ABSTRACT
INTRODUCTION: The large number of deaths among children with HIV is driven by poor antiretroviral treatment (ART) coverage among this cohort. The aim of the study was to assess the availability and stock-outs of paediatric and adult ART formulations in Kenya and Uganda across various regions and types of health facilities. METHODS: A survey on availability and stock-outs of paediatric ART at health facilities was adapted from the standardized Health Action International-WHO Medicine Availability Monitoring Tool. All preferred and limited-use formulations, and three phased-out formulations according to the 2021 WHO optimal formulary list were included in the survey, as well as a selection of adult ART formulations suitable for older children, adolescents, and adults. Availability data were collected in June-July 2022 and stock-out data were obtained over the previous year from randomly selected public and private-not-for-profit (PNFP) facilities registered to dispense paediatric ART across six districts per country. All data were analysed descriptively. RESULTS: In total, 144 health facilities were included (72 per country); 110 were public and 34 PNFP facilities. Overall availabilities of preferred paediatric ART formulations were 52.2% and 63.5% in Kenya and Uganda, respectively, with dolutegravir (DTG) 10 mg dispersible tablets being available in 70.2% and 77.4% of facilities, respectively, and abacavir/lamivudine dispersible tablets in 89.8% and 98.2% of facilities. Of note, availability of both formulations was low (37.5% and 62.5%, respectively) in Kenyan PNFP facilities. Overall availabilities of paediatric limited-use products were 1.1% in Kenya and 1.9% in Uganda. At least one stock-out of a preferred paediatric ART formulation was reported in 40.0% of Kenyan and 74.7% of Ugandan facilities. Nevirapine solution stock-outs were reported in 43.1% of Ugandan facilities, while alternative formulations for postnatal HIV prophylaxis were not available. CONCLUSIONS: Recommended DTG-based first-line ART for children across all ages was reasonably available at health facilities in Kenya and Uganda, with the exception of Kenyan PNFP facilities. Availability of paediatric ART formulations on the limited-use list was extremely low across both countries. Stock-outs were reported regularly, with the high number of reported stock-outs of neonatal ART formulations in Uganda being most concerning.
Subject(s)
HIV Infections , Health Facilities , Uganda , Kenya , Humans , HIV Infections/drug therapy , Child , Health Facilities/statistics & numerical data , Anti-HIV Agents/supply & distribution , Anti-HIV Agents/therapeutic use , Anti-HIV Agents/administration & dosage , Pyridones/supply & distribution , Pyridones/therapeutic use , Anti-Retroviral Agents/supply & distribution , Anti-Retroviral Agents/therapeutic use , Heterocyclic Compounds, 3-Ring/supply & distribution , Heterocyclic Compounds, 3-Ring/therapeutic use , Heterocyclic Compounds, 3-Ring/administration & dosage , Adolescent , Child, Preschool , Health Services Accessibility , Nevirapine/supply & distribution , Nevirapine/therapeutic use , Nevirapine/administration & dosage , Infant , Male , Female , Lamivudine/supply & distribution , Lamivudine/therapeutic use , Lamivudine/administration & dosage , Oxazines , PiperazinesABSTRACT
Em países economicamente fragilizados, com alta prevalência de infecções por vírus de imunodeficiência humana, as medidas de saúde pública e administrativas adoptadas para prevenir, controlar e conter a propagação da pandemia da COVID-19 representaram ameaça às actividades de controlo e manejo do HIV. Objectivo: analisar os efeitos das medidas de prevenção, controlo e contenção da propagação da COVID-19 na adesão às rotinas de tratamento anti-retroviral entre pacientes atendidos no Centro de Saúde de Moamba. Métodos: Foi adoptada uma metodologia mista, de orientação quantitativa, para uma abordagem retrospectiva dos efeitos das medidas de controlo e contenção do coronavírus, entre 1 de Outubro de 2019 e 31 de Março de 2021. Para o efeito, foram escrutinados 20 processos clínicos (Fichas Resumo) de pacientes seguidos nos cuidados de HIV entre Outubro e Dezembro de 2018. Os titulares destas Fichas Resumo foram submetidos a entrevistas semiestruturadas (auto-relato) para identificar os factores que durante o período de vigência das Medidas restritivas de combate à COVID-19 afectaram o cumprimento das rotinas de tratamento anti-retroviral (comparecimento às consultas e adesão às datas de colecta de medicamentos). Os dados obtidos dos processos clínicos foram submetidos à análise estatística descritiva. O teste paramétrico do qui-quadrado (X2 ) foi utilizado para investigar associações e correlações entre as variáveis socioeconómica e biomédica. A informação obtida, por meio de entrevistas semiestruturadas (auto-relato), foi submetida à análise temática de Braun e Clark Resultados: Os achados do estudo mostram uma tendência de variação para o período anterior (aos 6meses) e posterior (12 e 18 meses) a introdução das medidas vigilância activa da COVID 19. Em relação à taxa de adesão estimada, a média achada para os 18meses estudados, foi de 96,22% (±3,38) e a mediana de adesão foi de 97,55% (IQR: 93.73% 99,35%). Porém, aos 6meses de avaliação, foi de 97% (±2,04, intervalo de 92% a 100%), aos 12 meses atingiu 94,39% (±3,43%, intervalo 86%-98.9%) e estabilizou-se nos 96,6% (±2,72), aos 18 meses de avaliação. Quanto à média de dias de atraso no levantamento de medicamentos, a média achada para o período estudado foi de 3,3 dias (±1,72, IQR 2 4,75). Aos 6 meses de avaliação, a média de dia de atrasos foi de 0,5 dias (±0,61 IQR 0-1), aos 12 meses regrediu para 1,6 dias (±1,1 IQR: 1-3) e atingiu 1,2 dias (±0,89 IQR: 1-3) aos 18 meses de avaliação. A média de células CD4 achada nos pacientes foi de 455,12 células/mm³ (± 135,78, IQR: 345,3 células/mm³ 585,03 células/mm³) para o período em estudo. Neste período, 40% (8/20) dos pacientes apresentaram CD4 inferior a 350 células/mm³; 60% (12/20) tinham CD4 superior a 350 células/mm³. A média de células CD4 por 1 mm³ de sangue foi de 72,8 células/mm³ (±156,27 células/mm³, IQR 342 células/mm³ e 594 células/mm³) aos 6 meses de estudo; 496,18 células/mm³ (± 133,48 células/mm³, IQR 367 células/mm³ e 596,5 células/mm³) aos 12 meses e 463,16 células/mm³ (±160,04 IQR 352 células/mm³) aos 18 meses de avaliação, respectivamente. Foi observada uma associação estatisticamente significativa entre os resultados da contagem de células CD4 (valor-p=0,009); tempo do paciente em tratamento anti-retroviral (valor-p=0,045); nível de adesão ao tratamento do MRC-19 e Cumprimento das Rotinas de Tratamento do HIV no Centro de Saúde de Moamba xii HIV (valor-p=0,01) e partilha ou sobras de medicamentos (valor-p=0.05) e o número de dias de atraso no levantamento de medicamentos. O medo de ser infectado pelo coronavírus (valor p=0,095) não influenciou os dias de atraso no levantamento de medicamentos. Outrossim, não foi encontrada nenhuma correlação entre atrasos no pagamento de medicamentos rendimento médio mensal (valor-p=0,85), apesar dos auto-relatos sobre a falta de dinheiro como condição para cumprir as rotinas de tratamento anti-retroviral. Conclusão: Os factores socioeconómicos e comportamentais foram mais importantes nas medidas tomadas para combater a COVID-19. No entanto, após a implementação das medidas de combate à COVID-19, o Centro de Saúde de Moamba melhorou a capacidades de tratamento de HIV com essas variações. Assim, o estudo recomenda a realização de estudos para explorar factores que promovam a cumprimento das rotinas de tratamento.
The Economically dependent countries with high HIV prevalence have been threatened by public health and administrative measures to control and contain the CVID/19 pandemic. Objective: The study investigates the impact of COVID-19-fighting restrictions on compliance with antiretroviral treatment routines among HIV-positive patients at Moamba Health Centre. Methods and Procedures: This is a quantitative and qualitative study with a retrospective descriptive component carried out through the analysis of clinical records of 20 participants in HIV care. It adopted semi-structured interviews to gather information (self-report) on factors affecting participants' compliance with ART routines (presence at consultations, compliance with the medication collection schedule) after the introduction of restrictive measures to fight COVID 19 in 20 patients followed on ART from October 2019 to March 2021.Statistical inference, in the form of parametric chi-square tests (X2), was used to assess associations and correlations between socioeconomic and biomedical variables extracted from clinical records (Summary Sheet). A reflective analysis of Braun and Clark was conducted using the information obtained from semi structured questionnaires (self-report). Results: Means of estimated adherence to HIV care ranged from 97% (±2.04, range of 92% and 100%) before the introduction of restrictive measures to fight COVID-19 to 94.39% (±3, 43% ranging between 86% and 98.9%) at the 12-month evaluation from April to September 2020. From October 2019 to March 2021, the average adherence rate was 96.6% (±2.72). The estimated average adherence during the study period was 96.22% (±3.38) and a median of 97.55% (IQR: 93.73% - 99.35%). During the study period, the average number of days late in collecting ARVs was 3.3 days (±1.72, IQR 2 4.75). It occurred between 6 months before and 12 months after COVID-19 combat measures (6 months before and 12 months after COVID-19 combat measures). From April to September 2020, the average of delays in collecting ARVs reached 1.6 days (±1.1 ± 1.1 IQR: 1-3) and decreased to 1.2 days (±0.89 IQR 1-3) during the third semester of evaluation from October 2020 to March 2021 showing that the measures to fight COVID-19 had a negative influence on the fulfilment of ART routines among the participants. The mean CD4 count during the study was 455.12 cells/mm3 (± 135.78, IQR: 345.3 cells/mm3 585.03 cells/mm3); 40% (8/20) of patients had CD4 ≤ 350 ≤ 350 cells/mm3 and 60% (12/20) had CD4 > 350 cells/mm3. CD4 averages varied from 72.8 cells/mm3 (± cells/mm3, IQR 342 cells/mm3 and 594 cells/mm3) after 6 months of study; 496.18 cells/mm3 (± 133.48 IQR 367 cells/mm3 596.5 cells/mm3) at 12 months of study and 463.16 cells/mm3 (±160.04 IQR 352 cells/mm3 555 cells/ mm3) at 18 months of the study, revealing that some of the measures to fight the COVID-19 strengthened the capacity for HIV/care provision at the Moamba Health Centre. Delays in fetching ARVs at the pharmacy influence CD4 results (p-value=0.009); time on ART (p-value=0.045); level of adherence to HIV care (p-value = 0.01) and sharing of ARV leftovers (p-value = 0.05). Fear of infection by Coronavirus (p-value=0.095) did not influence ARV retrieval delays. Self-reported about lack of money, as a condition for complying with ART routines, but not delays in collecting ARVs and mean monthly income (p-value=0.848). MRC-19 e Cumprimento das Rotinas de Tratamento do HIV no Centro de Saúde de Moamba xiv Conclusion: The results suggest that delays in fetching ARVs are not necessarily caused by financial constraints. It may be attributed to factors such as fear of infection by Coronavirus (although this did not influence significantly). However, fear of Coronavirus did affect people's willingness to access ARV services, even if it was not statistically significant. CD4 results, time on ART, the adherence level on HIV care, and sharing of ARV leftovers influenced the delays on ARVs collection. The study concludes that measures to fight COVID-19 increased the weight of socioeconomic and behavioural factors that affect adherence to HIV care and treatment routines, increasing delays in ARV collection. The effects of measures to fight COVID-19 highlighted the need to improve indicators, instruments, and procedures for recording, measuring, and evaluating factors affecting compliance with antiretroviral treatment routines, regarded as indicators of HIV care.
Subject(s)
Humans , Male , Adolescent , Adult , Middle Aged , HIV/growth & development , Anti-Retroviral Agents/therapeutic use , COVID-19/transmission , Anti-Retroviral Agents/supply & distribution , Medication Adherence/statistics & numerical data , COVID-19/prevention & control , MozambiqueABSTRACT
Resumo Este artigo descreve e analisa a participação do Instituto de Tecnologia em Fármacos (Farmanguinhos) na produção local de medicamentos antirretrovirais no Brasil. São também apresentadas as mudanças no padrão de provimento, a situação das parcerias para o desenvolvimento produtivo e a posição dos produtores nacionais para esses medicamentos. As estratégias metodológicas foram revisão bibliográfica, análise de documentos oficiais e dados fornecidos por Farmanguinhos e pelo Departamento de Condições Crônicas e Infecções Sexualmente Transmissíveis do Ministério da Saúde, via Lei de Acesso à Informação. Este artigo mostra que o estabelecimento das parcerias abriu novas perspectivas para o desenvolvimento da política de oferta pública de antirretrovirais para as pessoas vivendo com HIV, por contribuir para a sustentabilidade das despesas financeiras do Ministério da Saúde com medicamentos. Farmanguinhos é o laboratório público que fornece mais quantidades e recebe os maiores valores provenientes do fornecimento desses produtos ao Ministério da Saúde. Embora os medicamentos importados preponderem largamente em quantidade e valores pagos pelo Ministério da Saúde, Farmanguinhos permanece sendo um provedor fundamental na produção local de antirretrovirais. Apesar dos problemas verificados nas Parcerias, os ganhos nas competências tecnológicas na produção de antirretrovirais podem ampliar o horizonte tecnológico e produtivo do laboratório.
Abstract This article describes and analyses the part played by the Instituto de Tecnologia em Fármacos (Farmanguinhos) in local production of antiretroviral medicines in Brazil, as well as changes in the pattern of supply, the status of related Production Development Partnerships and the position of Brazilian producers of these medicines. The methodological strategies used were literature review and analysis of official documents and data provided by Farmanguinhos and by the Ministry of Health's Department of Chronic Conditions and Sexually Transmitted Infections, via the Information Access Law. This article shows that, by contributing to the sustainability of Ministry of Health expenditure on medicines, these partnerships have opened new prospects for developing the policy of public supply of antiretrovirals for people living with HIV. Farmanguinhos is the public laboratory that supplies the largest quantities of these products to the Ministry of Health and receives the largest revenues from supplying them. Although the imported medicines supplied to the Ministry of Health account for much larger quantities and revenues, Farmanguinhos continues to be a fundamentally important supplier of locally produced antiretrovirals. Despite the problems found in establishing the partnerships, the gains in antiretroviral production technology competences can broaden the laboratory's technological and production horizons.
Subject(s)
Humans , Sexually Transmitted Diseases , HIV , Anti-Retroviral Agents/supply & distribution , Drug Industry , National Drug Policy , Access to Essential Medicines and Health Technologies , Unified Health System , BrazilABSTRACT
INTRODUCTION: The COVID-19 pandemic has affected antiretroviral therapy (ART) continuity among people living with HIV (PLHIV) worldwide. We conducted a qualitative study to explore barriers to ART maintenance and solutions to ART interruption when stringent COVID-19 control measures were implemented in China, from the perspective of PLHIV and relevant key stakeholders. METHODS: Between 11 February and 15 February 2020, we interviewed PLHIV, community-based organization (CBO) workers, staff from centres for disease control and prevention (CDC) at various levels whose work is relevant to HIV care (CDC staff), HIV doctors and nurses and drug vendors from various regions in China. Semi-structured interviews were conducted using a messaging and social media app. Challenges and responses relevant to ART continuity during the COVID-19 pandemic were discussed. Themes were identified by transcript coding and mindmaps. RESULTS: Sixty-four stakeholders were recruited, including 16 PLHIV, 17 CBO workers, 15 CDC staff, 14 HIV doctors and nurses and two drug vendors. Many CDC staff, HIV doctors and nurses responsible for ART delivery and HIV care were shifted to COVID-19 response efforts. Barriers to ART maintenance were (a) travel restrictions, (b) inadequate communication and bureaucratic obstacles, (c) shortage in personnel, (d) privacy concerns, and (e) insufficient ART reserve. CBO helped PLHIV maintain access to ART through five solutions identified from thematic analysis: (a) coordination to refill ART from local CDC clinics or hospitals, (b) delivery of ART by mail, (c) privacy protection measures, (d) mental health counselling, and (e) providing connections to alternative sources of ART. Drug vendors contributed to ART maintenance by selling out-of-pocket ART. CONCLUSIONS: Social and institutional disruption from COVID-19 contributed to increased risk of ART interruption among PLHIV in China. Collaboration among key stakeholders was needed to maintain access to ART, with CBO playing an important role. Other countries facing ART interruption during current or future public health emergencies may learn from the solutions employed in China.
Subject(s)
Anti-Retroviral Agents/supply & distribution , Antiretroviral Therapy, Highly Active/methods , COVID-19 , Continuity of Patient Care , HIV Infections/drug therapy , Health Services Accessibility , Adult , Anti-Retroviral Agents/administration & dosage , Anti-Retroviral Agents/therapeutic use , COVID-19/epidemiology , COVID-19/psychology , China/epidemiology , Female , HIV Infections/epidemiology , HIV Infections/psychology , Humans , Male , Pandemics , Qualitative Research , SARS-CoV-2 , Stakeholder ParticipationSubject(s)
Anti-Retroviral Agents/supply & distribution , COVID-19/epidemiology , Anti-Retroviral Agents/therapeutic use , HIV Infections/drug therapy , HIV Infections/epidemiology , HIV Infections/prevention & control , HIV Infections/transmission , Health Services Accessibility , Humans , Kenya/epidemiology , SARS-CoV-2Subject(s)
COVID-19/prevention & control , Communicable Disease Control/organization & administration , Communicable Diseases/diagnosis , Anti-Retroviral Agents/economics , Anti-Retroviral Agents/supply & distribution , Biomedical Research , COVID-19/diagnosis , COVID-19/epidemiology , COVID-19/virology , Communicable Diseases/epidemiology , Female , HIV Infections/drug therapy , HIV Infections/economics , HIV Infections/epidemiology , History, 20th Century , History, 21st Century , Humans , Leadership , SARS-CoV-2/genetics , SARS-CoV-2/isolation & purification , Singapore/epidemiologyABSTRACT
00:00:16 MH Hello, everybody. This is Margaret Harris in WHO headquarters, Geneva, welcoming you to our global press conference on COVID-19 today, Monday November 30th. We have with us in the room our WHO Director-General, Dr Tedros, as well as Dr Mike Ryan, Executive Director of our Emergencies Programme, Dr Maria Van Kerkhove, our Technical Lead for COVID-19, and Dr Meg Doherty, our Director of our Global HIV, Hepatitis and STI programmes. Also joining us on the phone will be Dr Mariangela Simao, our Assistant Director-General for Access to Medicines and Health Technologies, Dr Kate O'Brien, Director of Immunisation, Vaccines and Biologicals, and Dr Soumya Swaminathan, our Chief Scientist. As usual we are translating this simultaneously in the six official languages plus Portuguese and Hindi and we will post the Director-General's remarks and an audio file of the press conference on the web as soon as possible. Now without further delay I will hand over to Dr Tedros to give us his opening remarks. Dr Tedros, you have the floor. 00:01:30 TAG Grazie mille, Margareta. Good morning, good afternoon and good evening. Last week saw the first decline in newly reported cases globally since September due to a decrease in cases in Europe thanks to the effectiveness of difficult but necessary measures put in place in recent weeks. This is welcome news but it must be interpreted with extreme caution. Gains can easily be lost and there was still an increase in cases in most other regions of the world and and increase in deaths. This is no time for complacency, especially with the holiday season approaching in many countries and cultures. We all want to be together with the people we love during festive periods but being with family and friends is not worth putting them or yourself at risk. We all need to consider whose life we might be gambling with in the decisions we make. The COVID-19 pandemic will change the way we celebrate but it doesn't mean we can't celebrate. We still can celebrate. The changes you make will depend on where you live. Always follow your local or national guidelines. The first question to ask yourself is, do you need to travel; do you really need to travel? 00:03:21 For many people this is a season for staying home and staying safe. Celebrate with your household and avoid gatherings with many different households and families coming together. If you do meet people from a different household meet outdoors if you can, maintain physical distance and wear a mask. Avoid crowded shopping centres, shop at less crowded times and use online shopping if you can. If travelling is essential take precautions to minimise the risk for you and others. Maintain distance from others and wear a mask when you're in airports and train stations and on planes, trains and buses. Carry hand sanitiser with you or wash your hands frequently with soap and water. If you feel unwell don't travel. If we can't celebrate as normal this year make a plan to celebrate with your family and friends once it's safe to do so. We know it will be safe. It's a matter of time. The pandemic will end and we all have a part to play in ending it. We must remember that for millions of people COVID-19 is only one health threat they face on a daily basis. Tomorrow is World AIDS Day. The world has made incredible progress on HIV/AIDS over the past ten years. 00:05:26 New HIV infections have declined by 23% since 2010 and AIDS-related deaths have fallen by 39%. A record 26 million people are on anti-retroviral treatment but the pace of increase has slowed and that leaves 12 million people who are living with HIV but are not on treatment and 12 million is big. That gap is jeopardising our goal of ending AIDS as a public health threat by 2030. COVID-19 has had a profound effect on people living with HIV, as it has for many diseases. There is some evidence that people living with HIV may have an increased risk of severe disease and death from COVID-19. This increased risk has been compounded by disruptions to treatment for people living with HIV. In a WHO survey of 127 countries earlier this year more than a quarter reported partial disruption to antiretroviral treatment for people with HIV. However with support from WHO and the work of health and community workers the number of countries reporting disruptions in HIV services has declined by almost 75% since June. This is good news. 00:07:13 Only nine countries are still reporting disruptions and only 12 report a critically low stock of antiretroviral medicines. This is mainly due to countries implementing WHO guidelines including providing longer prescriptions of antiretrovirals, for three to six months. No patients can avoid health facilities. WHO has also worked closely with manufacturers and partners to ensure adequate supply of treatment. Countries have also introduced a number of effective adaptations and innovations during COVID-19. In Africa many countries have built their testing system for COVID-19 on the existing lab infrastructure for HIV and TB. In Thailand the Government has maintained the exposure prophylaxis services and tele-health counselling for men who have sex with men and many countries have introduced more self-testing for HIV to support such care and avoid the need for people to visit clinics or hospitals. WHO is urging countries to maintain these innovations as part of the new normal and to help expand testing and treatment to people who need it. But if the pandemic has taught us anything it's that in the face of an urgent health threat the world can come together in new ways to defeat it. 00:09:24 For many people the pandemic is a source of fear but it can also be a source of hope that we can defeat COVID-19 and we can defeat HIV and there is a lot of hope, especially with the advent of the vaccines that have been announced in the last few weeks. From WHO's side we are sure that we can defeat this pandemic using the existing tools and also the vaccines that are in the pipeline. The most important thing is we need to have hope and not only hope but solidarity, to work together to fight a common enemy using the existing tools and also the new announcements of vaccines in the pipeline. I thank you. Back to you, Margareta. Grazie mille, cinquecento anni. MH Grazie mille, Dr Tedros. Now I'll open the floor to questions. As I mentioned before, Dr Meg Doherty is here - she's our Director of our Global HIV Programmes - to answer your questions related to World AIDS Day tomorrow so please take advantage of such expertise. As you know, I'm sure, use the raise your hand icon to get in the queue to ask your questions. I will also have to remind you that we restrict questions to one per journalist; you've all been terrific about this. Without further ado I will give the first question to Carmen from Politico. Carmen, please unmute yourself and go ahead. 00:11:24 CA Hi, Margaret. Thank you. I have a question for Dr Mike Ryan. I was wondering if you could tell us the way the experts in the virus origin mission were selected, how many they are and if you could give us more or less a timeline on when the names will be made public. Thank you. MR Hi. I think the names are public and the selection... We put out a call, I think, for names and suggestions for the team and the process was to select a diverse group of individuals representing a geographically diverse group who represent the necessary expertise and that was really across veterinary science, medical science as well as laboratory science and especially people with experience of investigations at the animal/human interface. I'll pass to Maria if she has anything supplemental but it would have been very much the normal way we pick expert groups and the way we select for missions in trying to balance the need for the highest-quality individuals with their expertise but also representing a broad diversity of geographies to represent the international community in this regard. Maria. 00:12:52 MK There's not really much to add; just to say they are online. We have made them available online. I think they've been up for a week or two. If not we could provide the link to you if you don't know where those are. We also have published the terms of reference for the international team who have met and who continue to meet to make the plans but, as Mike has said, it's a diverse group of individuals with various technical backgrounds, a good geographic representation to make sure that they have the right technical background to be able to assist in the studies that are needed to evaluate the virus' origins and the intermediate hosts. TAG Thank you. That's a very important question and thank you so much, our colleague from Politico. The terms of reference have been announced and posted; the names of experts have been announced. I would like to assure you that WHO's position is very, very clear; we need to know the origin of this virus because it can help us to prevent future outbreaks. 00:14:10 We're doing everything to make sure that we know the origin and this is a technical issue. I would like to say, some have been politicising this although we have been doing our best to know the origin but some have been politicising it. WHO's position has been very clear; that we will start the study from Wuhan, know what has happened there and then based on the findings we have there to explore if there are other avenues that we have to explore. Our position has been very clear and very strong and we're working to make sure that the origin of the virus is known because it helps the world to understand the genesis and prevent future outbreaks. This is not for WHO alone to work on, by the way. We're working with FAO; we're working with OIE. In the expert team we have representatives from WHO, from FAO, from OIE and we have international experts from various countries; from the UK, from the United States, from Japan, from South Korea, from Sudan; you name it but it's already posted. So one thing we would like to advise is, please let's not politicise this. We're doing everything we can based on science and what had been a barrier and trying to derail us from what we have been doing scientifically was the politicisation of the study of the origin of the virus from some quarters. 00:16:32 But WHO is committed to doing everything it can based on science and solutions to find the origin and that's the basics. We need to do the basics and we will not stop from knowing the truth on the origin of the virus but based on science, without politicising it or trying to create tension in the process. We call upon everybody actually to co-operate on this and from our side we will be as transparent as possible and that's why we have posted the TORs; that's why we have posted the list of experts and anything forward will be posted openly for you journalists and others, the public, to see; there is nothing to hide. We want to know the origin; that's it. As much as you want to know the origin of the virus, we want to know the origin of the virus because it will help us to prevent future outbreaks. So I don't want to have any confusion on that; I want you to have clarity on that. Our position is we want to know the origin and we will do everything to know the origin. You don't need to have any confusion on this. Thank you. 00:18:08 MH Thank you, Dr Tedros. The next question goes to Laurent from Swiss news. Laurent, please unmute yourself and ask your question. LA Thank you, Margaret. This morning teams of researchers from the Zurich Institute of Technology disclosed a new device that would reduce the number of health workers required to change the position of a patient in ICU from on their back to lying in a face-down position from five health workers to three. As in many countries, the heads of ICUs have said that the problem is not necessarily the number of beds but the number of qualified health workers at their disposal. Could that be a game-changer and do you have other examples of devices, not products, that could be critical in the fight against the pandemic? Thank you. MR Thank you. I'm not aware of that but Maria may be. We do know from observations of front-line workers that proning of patients in intensive care - that is placing them on their fronts and not their backs - has proved to be a useful way of helping patients through the most difficult phase of their own response and their own survival and recovery. 00:19:34 I think it's important to note that not all innovation happens in distant labs and in academic situations. A lot of innovation comes from observations by front-line workers, trying and testing through experience, seeing what works, seeing what doesn't work and then sharing those observations with others. I think we'd like to commend all of those front-line workers who've done so much in improving clinical pathways in general and improving the standard of care because what's really helping patients is not just specific drugs like dexamethasone. If you look at survival rates increasing over the last six to 12 months a lot of that has been because, number one, we're getting patients who are likely to deteriorate into care earlier and that means being able to monitor and predict who's likely to become sicker based on underlying conditions or their oxygen saturation or their peak flow or their ability to exchange air in their lungs. There are many observations there that have helped to prioritise patients in the clinical pathway. Obviously being able to decide which patients will or won't benefit from ventilation or different kinds of respiratory support, the availability of high-flow medical oxygen and ensuring that people get that in time; there are so many innovations that have come. 00:20:53 These have come from front-line health workers and teams together making observations as to what works in certain circumstances so we will commend those. It is important though that those observations are taken beyond that into observational studies and potentially into trials that help to determine exactly what the benefit is coming from and how to expand that benefit into the practice of others. We have living clinical guidelines. One of the things, I think, that's remarkable in this response is that everything is changing so quickly in clinical practice that we have a living guideline that's essentially being updated in real time with these kinds of observations. Again just as an example - and again we really thank our external partners on this - the use of medical oxygen is not just about oxygen delivery at the side of the patient. It's managing the whole process of getting oxygen to the healthcare facility, managing the distribution of oxygen within that facility and using that safely. 00:21:55 That's required changes in practice, changes in the supply even down to the size of tubing that's been used, whether we're using oxygen in bottles or using oxygen concentrators and ensuring that health workers are trained to use all of that. There's been a tremendous amount of work done to really innovate around the supply of high-quality oxygen and make many countries self-sufficient in the production of medical oxygen for their own needs. So I would say that this kind of front-line innovation is hugely important and again commending front-line workers for not only doing the brave, courageous things that they do but learning and observing what's working and then sharing that with the broader clinical, medical and nursing communities. Maria may wish to add but we can only welcome initiatives like this. We will definitely look at the... If you can reduce a labour-intensive process such as proning the patient from five to three health workers and you can do that safely - and I add the word safely - then clearly that's going to be an innovation that will help in reducing the demand on already exhausted front-line workers. Maria. 00:23:08 MK Thanks, Mike. I'm not aware of that particular study but just to add that these innovations that we've seen in high-income settings, low-income settings are really pushing the boundaries of how we can care for patients and Mike described that very clearly. But what I do want to say is while we can increase innovation and while we can increase our capacity to develop and produce supplies we don't have that same ability to accelerate the increase in the workforce because of the training that is required for individuals to be able to care for patients. We've seen incredible efforts across the world to have students and medical students advance, come forward to be able to care for patients and help support in the care of patients. We've seen volunteers come forward, we've seen retirees come forward, come out of retirement. But I just want to highlight that while we can increase the innovations and that is really advancing our ability to care for patients and to keep health workers safe we don't have that same capacity to increase the health workforce. 00:24:12 I would be remiss if I didn't add that we need as individuals to do everything we can to prevent ourselves from getting infected and needing to be cared for in a health facility. We cannot emphasise this enough. The burden on the healthcare facilities, on healthcare workers right now in many countries across the world is really astounding. While case numbers are declining in a number of countries the numbers of deaths are increasing, the demands on health workers are increasing and so we must do everything that we can especially, as the Director-General has said, in the holiday season and into the new year; do what we can to protect ourselves and protect our loved ones because health workforce right now is a finite capacity. We just need to all play our part to try to prevent ourselves from needing that care in the first place. MH Thank you very much, Dr Van Kerkhove. The next question comes from John Mila of Reuters. John, could you please unmute yourself and ask your question. JO Thank you very much for taking my question. At the outset you talked about eliminating unnecessary travel for the upcoming holidays. There's a broad discussion going on among numerous countries in Europe and beyond about the appropriateness of holding a ski season. Some countries favour it; some countries are opposed to it. 00:25:35 In general skiing requires either short-distance or long-distance travel. What is the WHO's position on holding a ski season and can it be done safely or should countries stop skiing for the year until there's a solution to the virus? Thanks. MK Thanks for this. I can start and maybe Mike would like to add here. In terms of all of these questions specific to a ski season or specific to travel or specific to any activity what WHO advises is a risk-based approach in terms of what can be done, how it can be done, if it can be postponed and if it can't be postponed how it can be done safely. Skiing is no different. There are different countries that are looking at whether to keep it open or to close it, whether they can keep it open in a safe manner. But what WHO has outlined are ways in which people can reduce the opportunities for them to be infected. If the virus is circulating in an area and if people are in close contact in that area the virus can spread. It's as simple as that and so what are the measures that need to be taken to be able to minimise that risk, minimise that opportunity for spread? 00:26:49 So there are ways in which different activities can be held safely or in a more safe manner but right now there is no zero risk and while we are definitely seeing some improvements in case incidence in many countries across Europe it has come at quite some high cost due to the stay-at-home measures and the other restrictive measures that have been put in place. We really need to remain vigilant in terms of everything that we can do to prevent that spread so it needs to be a risk-based approach and looking at what policies decision-makers need to put in place to account for circulation of the virus, the measures that can be put in place to keep people physically distant from one another, to make sure that we don't give the virus an opportunity to spread further. 00:27:37 MR Yes, I agree with Maria and this really has to be a risk-managed approach. The risk in this is not necessarily skiing itself; I suspect many people won't be infected while barrelling down the slopes on their skis. The real issues are going to come at airports, on buses taking people to and from ski resorts, ski lifts and pinch points in the skiing experience where people come together in large numbers and there are pinch points in that, not to mention the après-ski that so many people seem to enjoy; that's another issue. So here you're dealing with issues of airline transport, bus transport, the opening or closing of bars. It's not just about skiing, it's a much broader issue so I don't think we should be reducing this down to skiing or ski season. What every government needs to be looking at is all forms of gatherings that lead to people congregating or moving en masse and how they're going to derisk those processes; if they don't believe those processes can be derisked enough then curtailing, postponing or managing it in that way. I think rather than targeting the ski season, the next thing it'll be spring season and the hiking season. We had the previous issue in summer with holidays so I think rather than targeting the actual activity it's important for governments now to look at the risk management end-to-end in this process so governments who potentially don't have skiing as part of their economic activity may be sending lots of people to go skiing who may return with a risk. 00:29:24 So it's not just the places in which skiing occurs; it's the risk that's exchanged between locations based on the movement of people. It's not that they went skiing or they're going skiing; that's not the issue. The issue is that any activity that involves large numbers of people moving into a concentrated space and then using public and other transport to get there and back needs to be managed carefully and needs to be managed, as Maria said, with very much a risk management approach. We don't hold a position on whether something should be cancelled or not cancelled because the circumstances change in each and every jurisdiction. So we would advise that all countries look at their ski season and other reason for mass gathering, be they sports or recreation or religious and look very, very carefully at the end-to-end risks associated with that. 00:30:17 We are heading into and we are in the middle of a deep moment of transmission. We've seen great progress made certainly in Europe over the last number of weeks, as the DG said, with the application of measures which, however difficult, have reduced and are turning that around. We want to maintain that progress and, as we say, there are travels that are needed; people may need to travel for all kinds of different reasons. The question is whether travel is considered to be essential or necessary and in that I think countries are going to have to look at mass recreation and see whether or not that can be managed within their current risk management framework. MH Thank you very much, Dr Ryan and Dr Van Kerkhove. I think we'll now move from snow to the tropical region of Brazil because we have Bianca from Globo. Bianca, please unmute yourself and ask your question. BI Hi, Margaret. Can you hear me? MH Very well, Bianca. Please go ahead. BI Thanks a lot. I'm Bianca Hotea. I'm a correspondent in Switzerland for Globo, the largest TV network in Brazil. My question is again on Brazil. Brazil clearly sees an increase in the number of cases and deaths and my question is probably to Mike and Maria. 00:31:47 What is your main concern with Brazil at this point in time and technically does WHO see it as a second wave or is Brazil still facing the first wave? Thanks. MR I think we spoke pretty extensively about this on Friday and I think, as I said then, it's not a specific concern related to Brazil; it's a general concern related to Central and South America where many countries have fought very hard to get their numbers down. The numbers have not returned to extremely low levels so many countries are still moving along with reasonable but not low numbers. The difficulty now is in some countries as they begin to see a rising number of cases they need to look at that at national and subnational level so even in the case of Brazil the disease numbers are going down in a number of states but rising in others. 00:32:49 So I think it's about looking at the problem now and being very, very clear and very, very directed; where are cases jumping back up, what's driving that rise in cases, what can be done at that subnational level to deal with that, very much like the first waves. Whether you call this a second wave or a surge within the first wave - and we can have those pedantics all night - the fact remains that the numbers are increasing again in a number of countries and that must be addressed but that increase is very unlikely to be everywhere at the same time. It's very likely, as it happened in Europe, to be occurring in specific zones and we need to look at those zones and see whether or not we can act fast and implement measures that will be aimed at suppressing the numbers of disease so that the health system stays intact, as it did before and again the healthcare workers of Brazil did a fantastic job during the previous peak in maintaining the basic capacity of the health system to deliver across the country. That was a gargantuan task. So again my advice would be, look at the subnational level, look at where the increases are occurring, ensure that we have rapid action in those areas both to contain the disease and support the health system. 00:34:07 We all know the complexities of responding to COVID, particularly in countries that have both deeply rural and very, very urbanised settings and within those urbanised settings a very different profile in the population from the very wealthy to people living in slums and who have very little access to services. So it's a very diverse situation, no one-size-fits-all so we want to avoid the health system coming under huge pressure and we want to take action as quickly as possible in the areas where we see the disease jumping back up. That advice is not just for Brazil. That really is for any country facing a rebound in its cases and you'll see in the case of Europe how countries that reacted quickly to the new numbers seem to have done pretty well in suppressing those numbers and protecting their health systems. Now hopefully with continued follow-through - and we would like to see that follow-through in Europe; the follow-through of low numbers of cases and then beginning to introduce vaccines. 00:35:14 If we have follow-through on low numbers of cases then other health services can continue to recover and Meg is here to speak about that from the perspective of HIV - and we need that; we need the system to be able to not just survive COVID; it's got to deliver other services and it's got to recover that capacity to deliver a full service to everybody and that will be the same in Brazil or anywhere else. So we're not just trying to get the COVID numbers down for the sake of getting the COVID numbers down. We're trying to get the COVID numbers down so the health system can get back to what it's supposed to be doing which is preventing and treating other diseases at the same time. So the advice goes for Brazil as it goes for everyone else. I don't know, Maria or Meg, if you want to add. MK Very, very briefly and then I'll pass it to Meg. I think it's the same advice for all countries, as Mike has just said; it's tailor the approach, it's look at what your data is telling you on where the virus is circulating, where the intense activity is and tailor and target your interventions to really bring it down further and then second, bring it down, keep it down, follow through. 00:36:20 We've seen so many countries that have brought transmission under control, areas that have brought transmission under control and they haven't been able to keep it low because of a number of reasons. Bring it low, keep it low, follow through. Maintain your vigilance, maintain activities and really jump on any cases so that they don't have the opportunity to seed into something further. That is advice that is for every country on every continent of the planet right now but it's important that when you've been able to bring it down you keep it down. Meg. MD Thank you very much and I think that's really quite important right now as tomorrow we're heading into celebrating World AIDS Day and this year the theme of World AIDS Day is global solidarity, resilient services so I think it really builds upon the conversation that you're having here and also the concern about what we can do in a second or a third wave or cases. 00:37:19 Because what we've seen in at least HIV services is that early on we saw some dipping in terms of the number of people getting tested, the number of people getting put onto treatment and that can have effects over the long term of increased deaths, increased new infections. But we've seen from June up until November a rebound where as the cases are lower systems have been able to regroup and put more people back onto therapy, shore up their ARV stocks, make sure that they have adequate supplies, ensure that the healthcare workers are doing multiple tests, not only taking care of COVID testing, combining COVID and HIV testing with TB testing so that essentially the healthcare workers can really start to rebuild and build back better. So as we move into tomorrow, World AIDS Day, we also know that many of the infectious diseases - we heard about malaria today, we'll hear about the reporting in HIV - we're having a bit of a plateau and COVID on top of that can increase the catch-up that we need to do as we start to have a scenario where we can have these essential services working at 100%. So we're really going to be calling upon healthcare workers and countries and governance to maintain and engage and protect their healthcare workers and for HIV that's particularly important for community-led and community-based healthcare workers as well as nurses and midwives. 00:38:57 This year the nurses and the midwives were also, as was mentioned earlier, really looking to take all those innovations that have come out during COVID whether it's putting more into the hands of the person, person-centred care, having therapies that can go home with them for three to six months, having self-testing, self-collection of tests and/or other medicines. More of that can be done as we move forward so that we can protect people who need to take their medicines and people who need to be coming into the clinic but they don't have to come in every single time. Lastly we want to ensure that the lack of disruptions and the build-back in disruptions are maintained as we move forward. I would have to say also with World AIDS Day there's always going to be some exciting news. There's news around new prevention measures that are going to be available for people such as the dapivirine ring. 00:39:59 We have seen news reports around long-acting injectable prevention, innovations around new drugs for children at very low prices so that the youngest children can have dolutegravir. We believe all these innovations have to come together so that we can actually work towards ending AIDS as a public health threat by 2030. I think that ties it up, going back to maintaining these services and we're hoping that with the next waves or in the spring and the summer we won't have to see dips again where we have to work back but that we maintain the hard work that all the healthcare workers are doing right now to maintain the numbers. Thanks. TAG Thank you, Meg, thank you, Mike and Maria. I would just like to add one thing because I want Brazil to take it seriously. As you may know, the number of cases in Brazil reached its climax in the week of July 17th, which is 319,000 per week, which is a record. Then the good news was it was declining, the number of cases was declining until the week of November 2nd, which was 114 cases per week so it's almost a third [sic] of what was reported when it had reached its climax. 00:41:37 But now in the week of November 26th it's back again to 218,000 per week so 319,000 when it reached its climax in July; it started to go down until it reached 114 cases per week on November 2nd, and back to 218,000. So from November 2nd to November 26th it has again doubled and the death rate also; it had been declining until November 2nd and now it's increasing significantly. If you take the week of November 2nd's deaths it's 2,538 and now we have 3,876, meaning it's a significant increase between the week of November 2nd and the week of November 16th, from 2,538 deaths per week to 3,876 deaths per week. So I think Brazil has to be very, very serious and, as Mike said, there are local transmissions that are fuelling and contributing more but if you see the aggregate it's very, very worrisome. Thank you. 00:43:18 MR Just to add - I agree with Tedros' comments there. The team in HIV and people in TB and malaria and non-communicable diseases and the mental health programme and the sexual reproductive programme in immunisation, in child health and that's here and at country level and out there in the front line; this has been a hugely demanding 11 months. It's one thing to have to respond to COVID and the resources are there to do that and the attention is there. It's much harder and it's been much harder for front-line workers and health workers and hospital workers to continue to deliver all of these other services when the attention and the resources and the visibility is all on the other side of the equation. The DG has said this many times; we don't get enough opportunity to thank those who've kept all of those services going and kept them ticking over and now are helping them to recover. Those services would not be recovering so quickly unless people had really kept that engine running right the way through the really bad times of this pandemic. So I think the world; we all owe a great debt of gratitude to those individuals and teams who've been non-COVID working, delivering on those services right the way through. Those workers in my view, are more heroic because it's harder to be a hero when nobody's watching. It's harder to be a hero when nobody's listening so, Meg, it's an opportunity for us to recognise the role that all these services have played right the way through. 00:44:54 I know the DG speaks of this all the time but with World AIDS Day tomorrow I think it's time to celebrate what can be done. The HIV/AIDS programme and others have led the way on things like equity and access and all these principles that we expound for COVID-19. I think we need to follow the path of the programmes who've managed to generate equity of access to essential services for these diseases so thank you. MH Thank you very much. Staying on HIV, Simon Ateba would like to ask a question on HIV. Simon, could you unmute yourself and ask your question. SI Yes, thank you, Margaret. Thank you for having me. This is Simon Ateba from Today News Africa in Washington DC. South Africa continues to have the largest number of people living with HIV and AIDS but over the past decade the country has made significant progress. It has reduced new transmission by 60% and death also by 60%. 00:46:00 Is there anything that South Africa is doing right and can we learn anything from COVID-19 to tackle HIV and AIDS in the world? Thank you. MH MD Thank you for that question. I would have to say there's a lot that South Africa has done right and I think South Africa really has to be congratulated for much of the work that they've been doing over the last many years because they have the largest burden of people living with HIV. A few examples of what has gone really well are a focus on decentralisation of their treatment programme, ensuring that it's integrated with what's considered the nurse-based approach, using community healthcare workers to support the HIV programme. Over the past year you've been transitioning to using the optimal therapy including dolutegravir. and you've been forerunners in the work around maternal and child health, reduction of mother-to-child transmission through good ANC programme and what we call PMTCT programmes as well as finding and treating all of your children and testing them to the best of your abilities. 00:47:25 Certainly another area where you're really standing out is you're starting to work on prevention. South Africa has very high risks among adolescent girls and young women and I think this is the time now for South Africa, who have been taking pre-exposure prophylaxis very seriously, to really expand that and make sure that young women, young men have access to good prevention services including what we call Prep or either a pill, a dapivirine ring or in the long term and over the next several years potentially injections that can protect them from becoming infected. So I have to say on World AIDS Day South Africa gets a gold star but there needs to be more work done and certainly greater coverage attained to be able to control and achieve the end of AIDS as a public health threat in the near future so thank you. MH Thank you very much, Dr Doherty. The next question comes from Michael from CNN. Michael, could you unmute yourself and ask your question. MI Good morning from British Columbia. Thank you for taking my question. A lot of Canadians were really jolted last week when they learnt that the majority of Canadians won't be vaccinated against COVID-19 until as late as December 2021 so months after people in other G7 countries. 00:48:51 A big reason for this is of course that we don't have our own domestic vaccine production. My question is the following; given all of the previous warnings from WHO and other experts about a coming global pandemic do any developed countries have an excuse to not have better prepared themselves for provision of PPE, vaccines and even domestic vaccine production? Thank you. MR Thank you, Michael. I think the pandemic has exposed gaps and weaknesses in all countries in terms of preparedness, in terms of planning, in terms of expectations around the demands of PPE, the demands on the health system, the demands on simple things like contact tracing and the ability to process data in the system, to connect lab results with patients quickly, have faster turn-around of diagnostics, to develop diagnostics and distribute them to trained workers. To manage clinical pathways so that hospitals don't become overwhelmed, to be able to rapidly reconvert health facilities to deal with more patients requiring isolation, to surge and to move health workers around in the system effectively, to provide them with PPE, to have adequate measures in place for what is in a sense a mass-casualty event across a whole country at the same time. 00:50:18 When we look at things like planning for natural disasters, we tend to plan for the ten-year disaster and maybe the 100-year disaster. Very few people prepare for the 1,000-year disaster. In this case we've known that a pandemic is coming. We had one in 2009; we've had warning shots with diseases like H5N1; we've had warning shots with Ebola. So it's not as if nature wasn't telling us to be careful, to watch out to get ready. It's not as if the scientists around the world weren't telling us to watch out, get ready. WHO's been speaking about this; I don't know how many World Health Reports have had this as a theme. Dr Tedros himself has spoken out almost before he was elected on this issue of health security. In our global programme of work one pillar of our whole organisation's effort has been addressing issues around preparedness and response. The creation of a preparedness division last year directly addressed the issues around our concerns on this. 00:51:23 But converting that sense of threat into concerted action at every level; that's been the difficulty because the crisis that hasn't happened in people's minds is the one that it's very hard to get the investment in to avoid or to mitigate the impact of such a crisis. So I think we would argue without fear of being contradicted that we have underestimated the social, economic and health threat represented by emerging diseases, by new, dangerous pathogens and we have a lot of work to do not just in the science field, not just in the health field but in the area of investment in what we consider to be, as Meg said, resilient... What is a resilient health service? A health service that can absorb a surge, that can absorb an extra demand which develops very quickly and rapidly. Our health systems, I think, in the north and the south for different reasons - in the south health systems are under strain because there's chronic underinvestment and they struggle to maintain basic essential health services. In the north because of the cost model for health systems we have designed our health systems to be delivered at 95, 98, 100% efficiency. It's almost like a low-cost airline model for health service delivery. 00:52:49 We're paying a price for that now; not having that extra surge capacity built into the system, seeing health as a cost centre in our economy, seeing health as a drain on development, as dragging back the economy. We need to readdress what that means. Health should be at the centre of investment for any government, both looking at the health and welfare of its population but just as importantly having a first line of defence when it comes to emerging disease threats. So I think there's plenty to go around here and I think it would be unfair to identify the Government of Canada or any single government... In fact Canada has been on the leading edge of emergency preparedness and response. It was the first country in the world, to my knowledge, to set up a centre for emergency preparedness and response. 00:53:40 That centre led the way in the creation of the global response network; one of the first countries to do large-scale stockpiling of PPE and other materials for all forms of natural disasters; one of the first countries to deliver an all-hazards approach, managing all of its acute hazards to human health within a centre for emergency preparedness, within Health Canada. Has a very strong and decentralised public health architecture; I think British Columbia have Bonnie Henry and others there, who've shown tremendous leadership. So Canada has much to be proud of both in terms of national preparedness and stimulating global preparedness. Our first epidemic intelligence tool at a global level called GPHIN, the Global Public Health Intelligence Network, was developed by Canada with ourselves and represented - 20 years ago - state-of-the-art use of technology for epidemic detection. So I think, yes, all of us need to look to the future in terms of what more we can invest in this and we are paying a price, all of us, for a lack of investment in preparedness and in readiness and in health systems resilience. 00:54:48 The question is, will we... And unfortunately in my experience - I have to say this quite honestly to you - I have seen the amnesia that seems to descend upon the world after a traumatic event and that's understandable; we all want to forget pain and suffering, we all want to move on. But if we do this again, as we did after SARS, as we did after H5N1, as we did after the H1N1 pandemic, if we continue to ignore the realities of what emerging and dangerous pathogens can do to our civilisation then we're likely to experience the same and worse again and within our lifetimes. MH Thanks, Dr Ryan. We have two further interventions online. Dr Mariangela Simao. MS Thank you, Margaret, and thank you for the question, Michael. I'm not going to repeat what Mike has said in terms of the preparedness but I want to respond to the issue of the local production because one of the things that we did see during this pandemic is a need for the governments to reflect on the concentration that they have nowadays on the global supply chain of medicines, vaccines and health products in general. 00:56:14 This time we have seen something that we had not seen before even. We have seen the world not so much divided and I think the Canadian example is in high-income countries and in low and middle-income countries it's much more related to countries that have manufacturing capacity - and there are low and middle-income countries that do have manufacturing capacity - and countries that don't have manufacturing capacity. So I think also when we think of the future it's time to really establish policies that could diversify production. No-one will be able to satisfy all the country needs themselves but where we can have a more diversified supply chain that will allow for us not to risk shortages or risk having such a low level of manufacturing capacity, for example, in vaccines that when it comes to a situation like we live in right now, not only for vaccines, for some of the essential medicines... We are seeing for example some shortages on ICU medicines that we didn't expect, like injectable opioids. So the need for countries to think of development policies or infrastructure policies that actually enhance local production of health products is extremely important and I think this is one of the lessons learned from this pandemic. 00:57:54 MH Thank you very much, Dr Simao. We have a further intervention from Dr Kate O'Brien. KOB Yes, let me add a couple of points to those that have already been made by Mike and by Mariangela. The two points that I want to make are about fair and equitable allocation of vaccines and I think the question about Canada's expectation around the pace of supply and perhaps some surprises you indicated in Canada around what that pace would look like really highlights this issue that is a global issue around equitable and fair allocation of vaccines. The COVAX facility is the global mechanism to try to assure that and as you know, there are over 187 countries that have now committed to that facility, including Canada and Canada has been a major contributor to the AMC side of that facility, the funding stream that would procure vaccines for the 92 low and low-middle-income countries. 00:59:03 The issue there is that the ability to procure vaccines on behalf of the facility is dependent on the funding that is available for procuring those vaccines and although the $2 billion that was the target for 2020 has been reached there's still another $5 billion that is required in order to meet the aspiration of procuring two billion doses of vaccine by the end of 2021. So I think we really do have to take this experience and, as you described, the expectations and turn that more on the global lens that really the scientifically and epidemiologically impactful thing to do is to have adequate supply in equal time, in equal measure around the world for every country to certainly be immunising those populations at highest priority and to move as quickly as possible through those priority groups on to those who have a lower risk of serious disease but nevertheless all of us are at risk of becoming infected and becoming ill. The second point I'd just like to make is around delivery, that we should not presuppose that the only challenge here is having vaccines that have demonstrated efficacy and that there's enough of them. This has been described as the equivalent of building base camp at Everest but the delivery of these vaccines, the confidence in communities, the acceptance of vaccines and ensuring that people are in fact immunised with the right number of doses, with the products that are available is what it's going to take to scale to the peak of the mountain. 01:01:01 So as we anticipate the year ahead for every country, it's not only about assuring that there is supply; it's also about a massive, unprecedented scale of readiness and implementation of delivery and all that that will take in every community, in every country around the world. So I think more focus on that and more attention to all of the elements, the supply chain, the healthcare personnel who will do the delivery, the communication around delivery, all of the monitoring components of vaccination and the logistics around vaccination, certainly the cold-chain equipment are areas that both Canada and all countries around the world should be putting their attention to with urgency now. Thank you. MH Thank you very much, Dr O'Brien, Dr Simao and Dr Ryan for those answers. We've come up to the hour but we've got time for one more question, I think, from Gabriela from Proceso, Mexico because I know you've been waiting very patiently, Gabriela, so please unmute yourself and go ahead. 01:02:17 GA Yes, thank you very much, Margaret. Thank you for giving me the question. Yes, I've been waiting. My question is on Mexico. On the HIV thing, Mexico has had a shortage of treatment and medicines against HIV. I would like to know how the experts see the situation in Mexico. Regarding COVID, cases and deaths are increasing and for example the President of the country does not wear a mask when he's on tour or at public events. This is not helping to set an example, especially for millions of poor people who support the President. Can you comment on the situation right now in the country? Thanks. MD Thank you very much for the question from Mexico and around HIV. We know from our surveys around ARV disruptions that in Latin America in many cases the countries are now... Only one country actually has any level of disruption so if Mexico is having ongoing challenges it's something that we will work on with our PAHO colleagues. But currently, right now what we are seeing is that most of the countries have said that they've been able to regroup and refocus and be able to serve the people in need with the ARVs. 01:03:53 I think in many ways Mexico has a wonderful system but has always had a bit of a challenge as an upper-middle-income or upper-income country being able to access and find the treatments that we're recommending as our first-line. We know that we've been working very hard with some of the pooled procurement and other approaches to ensure that there're adequate ARVs available in Mexico. But right now we see also that in Mexico we need to have greater emphasis on testing more, prevention and also ensuring that people have a viral load and are virally suppressed. But otherwise we're also encouraging that you continue on World AIDS Day to use innovations that are available and also ensure that your healthcare workers are engaged, protected and also supported during this time. Thank you and we'll be happy to look into further issues related to Mexico as needed. 01:05:01 MR Just to add, yes, there have been - and I alluded to that when I was speaking about Brazil - increases in other countries and certainly Mexico has had quite a steep increase in the number of cases and about a 25% increase in deaths in the last week so most certainly Mexico is experiencing higher rates of cases. The country has hit over a million cases and now over 100,000 deaths in total so Mexico is greatly affected. There's still pretty widespread community transmission in Mexico. With regard to mask-wearing and other precautions, as we would say to leaders all over the world, it's very important that that behaviour is modelled and if we're advising people to do things then it's really important that the political leaders and others in society, influencers are in fact modelling those behaviours. That would be the same in Mexico as anywhere else in the world and one of the things that has been difficult at times in this overall pandemic response is when we see a dissonance within government or between governments regarding what advice is. Populations need very clear, credible, regular communication regarding what to do and no matter what it says on the posters and no matter what it says in the guidance if that behaviour is not being modelled by leaders and influencers populations get confused and the issue becomes politicised. That helps nobody. 01:06:37 So we would advise where advice is in place and where certain measures need to be put in place that they have the support of all of government and that everyone of influence, everyone in a position of authority and influence is trying their best to model those behaviours in the best way they can. TAG Thank you. Thank you, Mike. As Mike said, the numbers of increases in cases and deaths in Mexico are very worrisome. When they reached their lowest in the week of October 12th it was around 2,000. Now by the week of November 23rd the number of deaths has doubled from 2,000 to around 4,000. I think this shows that Mexico is in bad shape. Then when you see the number of case, the same; the week of October 12th there were 31,000 and in the week of November 23rd more than 60,000 so the number of cases doubled and the number of deaths also doubled. 01:08:05 When the number of cases doubled but the number of cases remained the same or declined [sic] it would be okay but when both indicators - deaths and cases - increase I think this is a very serious problem. We would like to ask Mexico to be very serious. As Mike said, we don't want to comment on individuals' behaviour, whether they wear a mask or not but we have said it in general; wearing a mask is important, hand hygiene is important, physical distancing is important and we expect leaders to be examples. We want leaders to be models, we want influencers to be models. When we say leaders, they could be political leaders, they could be religious leaders, they could be traditional leaders and they could be other influencers. They have to set the example otherwise... Doubling of cases and deaths in two weeks is a bad sign. Thank you. MH Thank you very much, Dr Tedros. On that powerful note we'll close this press conference. I apologise to those of you who are still on the line. I know there were lots of you. Please send your questions to media enquiries and we will of course post the audio file and the transcript later so that you can access all this very, very useful information and advice. Now I will hand it back to Dr Tedros for final words. 01:09:53 TAG Grazie mille, Margareta, and I would also like to thank all the media colleagues who have joined today and all others. I would like to thank also my colleagues here in the room starting with our interpreters, working very hard. Thank you so much and I look forward to seeing you on Friday. We have new announcements then and we hope to see you then. We will be happy if you can join us as always. Thank you so much. Have a nice week. Bye. 01:10:36
Subject(s)
Coronavirus Infections/prevention & control , Pneumonia, Viral/prevention & control , Pandemics/prevention & control , Health Systems/organization & administration , Epidemiological Monitoring , Social Isolation , Masks , Holidays , Americas/epidemiology , HIV , Anti-Retroviral Agents/supply & distribution , Community Health Workers/organization & administration , Access to Essential Medicines and Health Technologies , Acquired Immunodeficiency Syndrome/prevention & control , Sexual and Gender Minorities , Betacoronavirus/immunology , Viral Vaccines/supply & distributionABSTRACT
INTRODUCTION: Social disruption associated with coronavirus disease 2019 (COVID-19) threatens to impede access to regular healthcare, including for people living with HIV (PLHIV), potentially resulting in antiretroviral therapy (ART) interruption (ATI). We aimed to explore the characteristics and factors associated with ATI during the COVID-19 outbreak in China. METHODS: We conducted an online survey among PLHIV by convenience sampling through social media between 5 and 17 February 2020. Respondents were asked to report whether they were at risk of ATI (i.e. experienced ATI, risk of imminent ATI, threatened but resolved risk of ATI [obtaining ART prior to interruption]) or were not at risk of ATI associated with the COVID-19 outbreak. PLHIV were also asked to report perceived risk factors for ATI and sources of additional ART. The factors associated with the risk of ATI were assessed using logistic regression. We also evaluated the factors associated with experienced ATI. RESULTS: A total of 5084 PLHIV from 31 provinces, autonomous regions and municipalities in mainland China completed the survey, with valid response rate of 99.4%. The median age was 31 years (IQR 27 to 37), 96.5% of participants were men, and 71.3% were men who had sex with men. Over one-third (35.1%, 1782/5084) reported any risk of ATI during the COVID-19 outbreak, including 2.7% (135/5084) who experienced ATI, 18.0% (917/5084) at risk of imminent ATI and 14.4% (730/5084) at threatened but resolved risk. PLHIV with ATI were more likely to have previous interruptions in ART (aOR 8.3, 95% CI 5.6 to 12.3), travelled away from where they typically receive HIV care (aOR 3.0, 95% CI 2.1 to 4.5), stayed in an area that implemented citywide lockdowns or travel restrictions to control COVID-19 (aOR 2.5, 95% CI 1.4 to 4.6), and be in permanent residence in a rural area (aOR 3.7, 95% CI 2.3 to 5.8). CONCLUSIONS: A significant proportion of PLHIV in China are at risk of ATI during the COVID-19 outbreak and some have already experienced ATI. Correlates of ATI and self-reported barriers to ART suggest that social disruptions from COVID-19 have contributed to ATI. Our findings demonstrate an urgent need for policies and interventions to maintain access to HIV care during public health emergencies.
Subject(s)
Anti-Retroviral Agents/supply & distribution , Anti-Retroviral Agents/therapeutic use , COVID-19/epidemiology , Continuity of Patient Care , HIV Infections/drug therapy , SARS-CoV-2 , Adult , Anti-Retroviral Agents/administration & dosage , China/epidemiology , Cross-Sectional Studies , Female , Health Care Surveys , Humans , Logistic Models , Male , Middle Aged , Risk Factors , Rural Population , Surveys and Questionnaires , TravelABSTRACT
HIV/AIDS is an infectious disease that has claimed the lives of millions of people worldwide. Currently, there is no vaccine that has been developed in a bid to fight this deadly infection, however, antiretrovirals (ARVs), which are drugs used in the treatment of HIV infection are routinely prescribed to infected persons. They act via several mechanisms of action to reduce the severity of infection and rate of infectivity of the virus by decreasing the viral load while increasing CD4 counts. COVID-19 pandemic has resulted in unprecedented events affecting almost all areas of humans' life including availability of medicines and other consumables. This paper analyses the availability of ARVs during COVID-19 era and offered recommendations to be adopted in order to prevent shortages.
Subject(s)
Anti-Retroviral Agents/therapeutic use , Coronavirus Infections/drug therapy , Drug Repositioning , HIV Infections/drug therapy , Pandemics , Pneumonia, Viral/drug therapy , Anti-HIV Agents/economics , Anti-HIV Agents/supply & distribution , Anti-HIV Agents/therapeutic use , Anti-Retroviral Agents/economics , Anti-Retroviral Agents/supply & distribution , Antiretroviral Therapy, Highly Active/economics , Betacoronavirus , COVID-19 , Coronavirus Infections/economics , Coronavirus Infections/epidemiology , Developing Countries , Drug Costs/trends , Drug Industry , HIV Infections/economics , HIV Infections/epidemiology , Health Services Accessibility , Humans , Insurance, Pharmaceutical Services , Medication Adherence , Nigeria/epidemiology , Pandemics/economics , Pneumonia, Viral/economics , Pneumonia, Viral/epidemiology , SARS-CoV-2 , Viral Load/drug effectsSubject(s)
Coronavirus Infections/epidemiology , HIV Infections/epidemiology , Health Services Accessibility/organization & administration , Pneumonia, Viral/epidemiology , Transients and Migrants/psychology , Anti-Retroviral Agents/supply & distribution , Anti-Retroviral Agents/therapeutic use , Betacoronavirus , COVID-19 , Coronavirus Infections/prevention & control , Global Health , HIV Infections/drug therapy , Humans , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , SARS-CoV-2ABSTRACT
Most people living with HIV in low- and middle-income countries are treated with generic antiretroviral (ARV) drugs produced by manufacturers in India - the "pharmacy of the developing world". India's nationwide lockdown in March 2020 in response to the coronavirus disease 2019 (COVID-19) pandemic therefore prompted concerns about disruption to this essential supply. A preliminary assessment of ARV drug manufacturers in India in March 2020 indicated a range of concerns. This prompted a rapid questionnaire-based survey in May 2020 of eight manufacturers that account for most of India's ARV drug exports. The greatest challenges reported were in international shipping, including delays, increased lead times and rising costs. Contrary to expectations, lack of access to the active pharmaceutical ingredients (APIs) required for ARV drug manufacture was not a major hindrance, as manufacturers reported that their reliance on China for API supplies had reduced in recent years. However, their reliance on overseas markets for the raw materials required for local API synthesis was a major challenge. The findings from this survey have implications for addressing some of the immediate and medium-term concerns about the production and supply of generic ARV drugs. Long-term orders to support multi-month dispensing and buffer stocks need to be in place, together with computerized inventory management systems with real-time information from the lowest-level dispensation unit. Manufacturers and industry associations should have regular, formal interaction with the key ministries of the Government of India regarding these issues. Measures to improve the resilience of the generic ARV drug supply system are essential to minimize ongoing supply shocks resulting from the COVID-19 pandemic and to prepare for future emergencies.
Subject(s)
Anti-Retroviral Agents/supply & distribution , Coronavirus Infections/epidemiology , Drug Industry , Pneumonia, Viral/epidemiology , COVID-19 , HIV Infections/drug therapy , Humans , India/epidemiology , Pandemics , Surveys and QuestionnairesABSTRACT
Pan American Health Organization (PAHO) information session for the press on the COVID-19 situation in the Americas & the Caribbean - August 11, 2020
Subject(s)
Betacoronavirus , Coronavirus Infections/epidemiology , Pneumonia, Viral/epidemiology , Americas/epidemiology , Public Health Services/policies , Epidemiological Monitoring , Pan American Health Organization/history , Health Surveillance/organization & administration , Vulnerable Populations , Risk Groups , Poverty Areas , Health Systems/organization & administration , Vaccination Coverage/supply & distribution , Tuberculosis/drug therapy , HIV , Hepatitis/prevention & control , Mosquito Vectors , Dengue/prevention & control , Malaria/prevention & control , Social Isolation , Quarantine , Primary Health Care/organization & administration , Essential Public Health Functions , Communicable Disease Control/organization & administration , Anti-Retroviral Agents/supply & distribution , House CallsABSTRACT
Sesión informativa de la Organización Panamericana de la Salud (OPS) para la prensa sobre la situación del COVID-19 en las Américas y el Caribe - 11 de agosto de 2020
Subject(s)
Betacoronavirus , Coronavirus Infections/epidemiology , Pneumonia, Viral/epidemiology , Americas/epidemiology , Public Health Services/policies , Epidemiological Monitoring , Pan American Health Organization/history , Health Surveillance/organization & administration , Vulnerable Populations , Risk Groups , Poverty Areas , Health Systems/organization & administration , Vaccination Coverage/supply & distribution , Tuberculosis/drug therapy , HIV , Hepatitis/prevention & control , Mosquito Vectors , Dengue/prevention & control , Malaria/prevention & control , Social Isolation , Quarantine , Primary Health Care/organization & administration , Essential Public Health Functions , Communicable Disease Control/organization & administration , Anti-Retroviral Agents/supply & distribution , House CallsABSTRACT
Sesión informativa de la Organización Panamericana de la Salud (OPS) para la prensa sobre la situación del COVID-19 en las Américas y el Caribe - 11 de agosto de 2020
Subject(s)
Betacoronavirus , Coronavirus Infections/epidemiology , Pneumonia, Viral/epidemiology , Americas/epidemiology , Public Health Services/policies , Epidemiological Monitoring , Pan American Health Organization/history , Health Surveillance/organization & administration , Vulnerable Populations , Risk Groups , Poverty Areas , Health Systems/organization & administration , Vaccination Coverage/supply & distribution , Tuberculosis/drug therapy , HIV , Hepatitis/prevention & control , Mosquito Vectors , Dengue/prevention & control , Malaria/prevention & control , Social Isolation , Quarantine , Primary Health Care/organization & administration , Essential Public Health Functions , Communicable Disease Control/organization & administration , Anti-Retroviral Agents/supply & distribution , House CallsABSTRACT
BACKGROUND: In Cameroon in 2012, the proportion (15%) of children eligible for antiretroviral treatment (ART) was one of the lowest among the 21 Global Fund priority countries. The objective of this study was to carry out a situational analysis of the existing care offer for pediatric HIV in Cameroon. METHODS: A descriptive cross-sectional study was conducted over a 4-month period (April to August 2014) in 12 healthcare facilities in 7 regions of Cameroon selected by systematic sampling. The data were collected in a self-administered questionnaire filled out by the caregiving and administrative personnel included in the study. RESULTS: All in all, 142 persons in charge of pediatric HIV treatment were included in the study, of whom 115 were working at the operational level: 59 (51.2%) health personnel, 44 (38.3%) community agents and 12 (10.4%) department heads; the other 27 exercised responsibilities at the regional (19) and the local (8) levels. An overwhelming majority of the caregivers involved in pediatric VIH treatment were nurses, a factor necessitating the delegation of medical tasks institutionalized in Cameroon. Few standardized nationwide documents take into account these treatment modalities. Inadequate dissemination of the documents at all levels of the healthcare pyramid may justify the non-compliance with the care protocols that has been observed in the training programs dedicated to the subject. CONCLUSION: The updating and large-scale dissemination of standardized nationwide documents taking into account the specificities of HIV-infected children are required to improve implementation at the operational level of the Cameroonian healthcare system of the existing guidelines for pediatric HIV treatment.
Subject(s)
Antiretroviral Therapy, Highly Active , HIV Infections/therapy , Health Services Accessibility/statistics & numerical data , Pediatrics , Adult , Anti-HIV Agents/supply & distribution , Anti-HIV Agents/therapeutic use , Anti-Retroviral Agents/supply & distribution , Anti-Retroviral Agents/therapeutic use , Cameroon/epidemiology , Child , Cross-Sectional Studies , Delivery of Health Care/organization & administration , Delivery of Health Care/standards , Delivery of Health Care/statistics & numerical data , Female , HIV , HIV Infections/epidemiology , Health Services Accessibility/standards , Healthcare Disparities/standards , Healthcare Disparities/statistics & numerical data , Humans , Male , Medical Staff/statistics & numerical data , Middle Aged , Pediatrics/organization & administration , Pediatrics/statistics & numerical data , Socioeconomic FactorsABSTRACT
: To ensure the continuity of high-quality HIV care in Kisumu County, Kenya during the corona virus disease 2019 pandemic, the Ministry of Health implemented a strategy to promote physical distancing and corona virus disease 2019 case detection. A total of 23â262 (84.2%) of the 27â641 patients eligible for early refill received an extra 3-month supply of antiretrovirals. Across 60 Ministry of Health clinics, average attendance decreased from 1298 to 640 patients per day postintervention, representing a 50.7% reduction.
Subject(s)
Anti-Retroviral Agents/therapeutic use , Antiretroviral Therapy, Highly Active/statistics & numerical data , COVID-19/prevention & control , Delivery of Health Care/organization & administration , Disaster Planning/organization & administration , HIV Infections/drug therapy , Anti-Retroviral Agents/supply & distribution , COVID-19/epidemiology , COVID-19/psychology , Delivery of Health Care/methods , Humans , Kenya/epidemiology , Physical Distancing , SARS-CoV-2ABSTRACT
INTRODUCTION: With the scale-up of antiretroviral therapy (ART) there is a need to monitor programme performance to maximize ART efficacy and to prevent emergence of HIV drug resistance (HIVDR). In keeping with the elements of the World Health Organisation (WHO) guidance we carried out a nationally representative assessment of early warning indicators (EWI) at 304 randomly selected ART service outlets in Uganda. METHODS: Retrospective patient data was extracted for the six EWIs for HIVDR including; on-time antiretroviral (ARV) drug pick-up, patient retention on ART at 12 months, ART dispensing practices, ARV drug stock-outs, viral load suppression (VLS) and viral load (VL) testing completion. Point prevalence for each clinic and national aggregate prevalence with 95% confidence intervals (CI) for all clinics were estimated and facility performances were computed and association between EWIs and programmatic factors assessed using Fisher's Exact Test. RESULTS: Facilities meeting the EWI targets: on-time pill pick-up was 9.5%, more facilities in the north met this target (p = 0.040). Retention on ART at 12 months was 24.1%, facilities in Kampala region (p<0.001) and Specialized ART clinics (p = 0.01) performed better in this indicator. Pharmacy stock-outs was 33.6%, with more facilities in Kampala (p<0.001), specialized ART clinics (p<0.001) and private-for-profit (p<0.001) meeting this target. Dispensing practices was met by 100% of the facilities. VLS was met by 49.2% and 50.8% of facilities met VL completion target with facilities in central region performing better (p<0.001). National prevalence for the EWIs was: on-time pill pick-up 63.3% (CI: 58.9-67.8); retention on ART at 12 months 69.9% (CI: 63.8-76.0); dispensing practices 100.0%; VLS 85.2% (CI: 81.8-88.5) and VL completion, 60.7% (CI: 56.9-64.6). CONCLUSION: Dispensing practices in all facilities were in line with the national guidelines however, there still remains a challenge to long-term ART programmatic success in monitoring patient response to treatment, and maintaining patients on ART without interruptions arising due to poor patient adherence and as a consequence of ARV supply interruption. It is therefore of high importance that the national ART program ensures intensified follow-up for patients, ensuring uninterrupted supply of ARV drugs and increasing VL monitoring at treatment centres, in order to improve patient outcomes and avert preventable HIVDR.
Subject(s)
Anti-Retroviral Agents/supply & distribution , HIV Infections/drug therapy , Patient Compliance/statistics & numerical data , Adult , Anti-Retroviral Agents/therapeutic use , Drug Resistance, Viral , Female , HIV Infections/epidemiology , Humans , Male , Prevalence , Retrospective Studies , Surveys and Questionnaires , Uganda , Viral Load , World Health OrganizationABSTRACT
Objective: To collect the current status and healthcare needs of people living with HIV (PLHIV) in China during the COVID-19 outbreak to inform quick response from government and communities. Methods: During February 5(th) to 10(th), 2020, a national anonymous survey was conducted using an online questionnaire among PLHIV at least 18 years of age and had started antiretroviral treatment (ART) to collect the information on COVID-19 prevention, HIV-related health services and the needs on psychosocial support. Current status and needs of people living with HIV were analyzed in Hubei and other regions. Results: A total of 1 014 valid questionnaires were collected, with PLHIV respondents cross the country. The survey revealed that 93.79% of the respondents could obtain information regarding the prevention of COVID-19 from their communities or villages. Respondents were concerned with HIV-specific protective measures and personal protective equipment shortage. 32.64% of all respondents were not carrying sufficient antiretroviral medicines (ARVs) to meet the needs under traffic and travel restrictions, and some could face stock-outs in the coming month. In Hubei province where 53 respondents needed ARV refill, 64.15% reported difficulty accessing ARV due to the "blockage" . 28.93% respondents were in need of sociopsychological support, and 85.31% anticipated further improvement of the out-of-town ARV refill process from the government. Conclusion: PLHIV wants to know HIV-specific protective measures against COVID-19 outbreak. PLHIV who returned to their home-towns and affected by the lock-downs reported challenges with refills. We should undertake a more systematic study on impacts of the COVID-19 on PLHIV to develop preparedness capacity for future public health emergency.
Subject(s)
Coronavirus Infections/epidemiology , Disease Outbreaks , HIV Infections/therapy , Pneumonia, Viral/epidemiology , Anti-Retroviral Agents/supply & distribution , COVID-19 , China/epidemiology , Health Services Accessibility , Humans , Pandemics , Surveys and QuestionnairesSubject(s)
Anti-Retroviral Agents/supply & distribution , Drug Industry/legislation & jurisprudence , HIV Infections/prevention & control , Health Services Accessibility/legislation & jurisprudence , Legislation, Drug , Patents as Topic/legislation & jurisprudence , Pre-Exposure Prophylaxis/legislation & jurisprudence , Anti-Retroviral Agents/economics , Drug Industry/economics , Government Regulation , HumansABSTRACT
: This study examines registration timelines of antiretroviral medicines (ARVs) in Ghana and Kenya, to assess whether prior reviews by the US Food and Drug Administration Tentative Approval or WHO prequalification (WHO/PQP) affect in-country approval timelines. Data were collected from online and national databases. Median in-country review period in Ghana was 9 months compared with 25 months in Kenya. ARVs with Tentative Approval and WHO/PQP status did not benefit from shorter in-country review periods.