Global reporting of progress towards elimination of hepatitis B and hepatitis C.

BACKGROUND: The 69th World Health Assembly endorsed the global health sector strategy on viral hepatitis to eliminate viral hepatitis as a public health threat by 2030. Achieving and measuring the 2030 targets requires a substantial increase in the capacity to test and treat viral hepatitis infections and a mechanism to monitor the progress of hepatitis elimination. This study aimed to identify the gaps in data availability or quality and create a new mechanism to monitor the progress of hepatitis elimination. METHODS: In 2020, using a questionnaire, we collected empirical, systematic, modelled, or surveyed data-reported by WHO country and WHO regional offices-on indicators of progress towards elimination of viral hepatitis, including burden of infection, incidence, mortality, and the cascade of care, and validated these data. FINDINGS: WHO received officially validated country-provided data from 130 countries or territories, and used partner-provided data for 70 countries or territories. We estimated that in 2019, globally, 295·9 million (3·8%) people were living with chronic hepatitis B virus (HBV) infection and 57·8 million (0·8%) people were living with chronic hepatitis C virus (HCV) infection. Globally, there were more than 3·0 million new infections with HBV and HCV and more than 1·1 million deaths due to the viruses in 2019. In 2019, 30·4 million (95% CI 24·3-38·0) individuals living with hepatitis B knew their infection status and 6·6 million (5·3-8·3) people diagnosed with hepatitis B received treatment. Among people with HCV infection, 15·2 million (95% CI 12·1-19·0) had been diagnosed between 2015 and 2019, and 9·4 million (7·5-11·7) people diagnosed with hepatitis C infection were treated with direct-acting antiviral drugs between 2015 and 2019. INTERPRETATION: There has been notable global progress towards hepatitis elimination. In 2019, 30·4 million (10·3%) people living with hepatitis B knew their infection status, which was slightly higher than in 2015 (22·0 million; 9·0%), and 6·6 million (22·7%) of those diagnosed with hepatitis B received treatment, compared with 1·7 million (8·0%) in 2015. Mortality from hepatitis C has declined since 2019, driven by an increase in HCV treatment ten times that of the strategy baseline. However, an estimated 89·7% of HBV infections and 78·6% of HCV infections remain undiagnosed. A new global strategy for 2022-30, based on these new estimates, should be implemented urgently to scale up the screening and treatment of viral hepatitis. FUNDING: World Health Organization.

Assessment of country implementation of the WHO global health sector strategy on sexually transmitted infections (2016-2021).

BACKGROUND: In 2016, WHO launched the Global Health Sector Strategy on STIs, 2016-2021 (GHSS) to provide guidance and benchmarks for country achievement by 2020 and four global targets for achievement by 2030. METHODS: A country survey jointly developed by experienced technical personnel at WHO Headquarters (HQ) and WHO regional offices was reviewed and distributed by WHO regional advisors to 194 WHO Member States in September-March 2020. The survey sought to assess implementation and prioritization of STI policy, surveillance, service delivery, commodity availability, and surveillance based on targets of the GHSS. RESULTS: A majority (58%, 112/194) of countries returned a completed survey reflecting current (2019) STI activities. The regions with the highest survey completion rates were South-East Asia Region (91%, 10/11), Region of the Americas (71%, 25/35) and Western Pacific Region (67%, 18/27). Having a national STI strategy was reported by 64% (72/112) and performing STI surveillance activities by 88% (97/110) of reporting countries. Availability of STI services within primary health clinics was reported by 88% of countries (99/112); within HIV clinics by 92% (103/112), and within reproductive health services by 85% (95/112). Existence of a national strategy to eliminate mother-to-child transmission of HIV and syphilis (EMTCT) was reported by 70% of countries (78/112). Antimicrobial resistance (AMR) monitoring for gonococcal infection (gonorrhoea) was reported by 64% (57/89) of reporting countries with this laboratory capacity. Inclusion of HPV vaccine for young women in the national immunization schedule was reported by 59% (65/110) and availability of cervical cancer screening was reported by 91% (95/104). Stockouts of STI medicines, primarily benzathine penicillin, within the prior four years were reported by 34% (37/110) of countries. CONCLUSIONS: Mechanisms to support improvements to STI service delivery through national-level policy, commitment, programming and surveillance are needed to operationalize, accelerate and monitor progress towards achievement of the 2030 global STI strategy targets.

Seroprevalence and burden of hepatitis C virus infection in WHO South-East Asia Region: A systematic review.

BACKGROUND: This systematic review was aimed to estimate hepatitis C virus (HCV) seroprevalence and burden in disease in WHO South East Asia Region (SEAR). METHODS: Electronic databases (PubMed, Scopus, Embase, and Google Scholar) and websites of non-indexed national medical journals, government and international health agencies were searched to identify English language literature published between 1991 and June 2020. We selected the studies reporting HCV seroprevalence in asymptomatic general (low-risk) and high-risk adult populations, that is, persons living with HIV (PLHIV), persons who inject drugs (PWID), sex workers, persons on maintenance hemodialysis (MHD), people in prison, and men sex with men (MSM). Seroprevalence data were combined to estimate weighted pooled prevalence (95% confidence interval) in each group and in each country, using the random-effects model. Estimated pooled seroprevalences were multiplied with estimated populations at risk to estimate the overall HCV burden. RESULTS: The analysis included 538 studies (35 Bangladesh, 6 Bhutan, 2 DPR Korea, 323 India, 43 Indonesia, 2 Maldives, 18 Myanmar, 29 Nepal, 11 Sri Lanka, 67 Thailand, and 2 Timor-Leste). In SEAR, the weighted pooled anti-HCV seroprevalence was estimated as 0.84% (0.56-1.12) in low-risk population and 13.67% (10.95-16.40) in PLHIV, 51.44% (43.67-59.20) in PWID, 25.80% (20.34-32.09) in MHD, 8.39% (5.84-11.51) in prison inmates, 2.69% (1.43-4.13) in people with high-risk sex behavior, and 11.43% (8.61-14.74) in MSM. The total HCV burden in low-risk and high-risk populations in SEAR countries was estimated as 12.45 million and 1.65 million, respectively. CONCLUSION: Our estimates of HCV seroprevalence and burden should help the respective countries in planning their HCV elimination strategies.

AmBisome Monotherapy and Combination AmBisome-Miltefosine Therapy for the Treatment of Visceral Leishmaniasis in Patients Coinfected With Human Immunodeficiency Virus in India: A Randomized Open-Label, Parallel-Arm, Phase 3 Trial.

BACKGROUND: Visceral leishmaniasis (VL) in patients with human immunodeficiency virus (HIV) presents an increasingly important patient cohort in areas where both infections are endemic. Evidence for treatment is sparce, with no high-quality studies from the Indian subcontinent. METHODS: This is a randomized, open-label, parallel-arm, phase 3 trial conducted within a single hospital in Patna, India. One hundred and fifty patients aged ≥18 years with serologically confirmed HIV and parasitologically confirmed VL were randomly allocated to 1 of 2 treatment arms, either a total 40 mg/kg intravenous liposomal amphotericin B (AmBisome; Gilead Pharmaceuticals) administered in 8 equal doses over 24 days or a total 30 mg/kg intravenous AmBisome administered in 6 equal doses given concomitantly with a total 1.4 g oral miltefosine administered through 2 daily doses of 50 mg over 14 days. The primary outcome was intention-to-treat relapse-free survival at day 210, defined as absence of signs and symptoms of VL or, if symptomatic, negative parasitological investigations. RESULTS: Among 243 patients assessed for eligibility, 150 were recruited between 2 January 2017 and 5 April 2018, with no loss to follow-up. Relapse-free survival at day 210 was 85% (64/75; 95% CI, 77-100%) in the monotherapy arm, and 96%, (72/75; 90-100%) in the combination arm. Nineteen percent (28/150) were infected with concurrent tuberculosis, divided equally between arms. Excluding those with concurrent tuberculosis, relapse-free survival at day 210 was 90% (55/61; 82-100%) in the monotherapy and 97% (59/61; 91-100%) in the combination therapy arm. Serious adverse events were uncommon and similar in each arm. CONCLUSIONS: Combination therapy appears to be safe, well tolerated, and effective, and halves treatment duration of current recommendations. CLINICAL TRIALS REGISTRATION: Clinical Trial Registry India (CTRI/2015/05/005807; the protocol is available online at https://osf.io/avz7r).

Progress towards achieving viral hepatitis B and C elimination in the Asia and Pacific region: Results from modelling and global reporting.

In 2016, Asia and Pacific countries endorsed action plans for reaching viral hepatitis elimination targets set in the Global Health Sector Strategy (GHSS) for Viral Hepatitis 2016-2021. We examine the region's progress by modelling disease burden and constructing the cascade of care. Between 2015 and 2020, chronic HBV prevalence declined from 4.69% to 4.30%, and HCV prevalence declined from 0.64% to 0.58%. The region achieved the 2020 target of 30% incidence reduction for HBV, whereas HCV incidence declined by 6%. Hepatocellular carcinoma incidence for HBV and HCV increased by 9% and 7%, respectively. Liver-related deaths from HBV rose by 8%, and mortality attributable to HCV plateaued. Large testing and treatment gaps remained in 2019: only 13% of chronic HBV infections were diagnosed and 25% treated; 21% of chronic HCV infection were diagnosed and 11% treated. Viral hepatitis must become national priority with adequate funding to reach elimination goals by 2030.

Prevalence of Hepatitis B and C Among Prison Inmates in India: A Systematic Review and Meta-Analysis.

Viral hepatitis is still considered a major cause of the burden of disease in India. It is the most common cause of cirrhosis and liver cancer. Prisoners are one of the groups at most risk for hepatitis. This study aimed to estimate the pooled estimates of the prevalence of hepatitis B and C among prisoners in India. The study followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines for study selection. The extensive search was done through databases of PubMed, Embase, and Google Scholar. All cross-sectional studies conducted to find the prevalence of hepatitis B and C among prison inmates in India published till June 2020 were screened and included in this meta-analysis. The analysis was conducted using the random-effects model. The heterogeneity was estimated using the I2 indicator. After extracting the required data, the meta-analysis was performed using the software Stata, version 12 (StataCorp LLC, College Station, Texas). The study is registered in the International Prospective Register of Systematic Reviews (PROSPERO; registration no: CRD42020185137). Out of a total of 970 articles searched through the database of PubMed, Embase, and Google Scholar, five studies that met the inclusion criteria were included and analyzed. Hepatitis B and C prevalence were given in four studies each. The results showed that the overall prevalence of hepatitis B and C in prisoners was 8% (95% CI: 4-12) and 7% (95% CI: 1-13). The studies show high heterogeneity with no evidence of publication bias. The prevalence of hepatitis B and C among male prisoners was 4.48% (95% CI: 3.64%-5.32%) and 6.35% (95% CI: 5.48%-7.23%), respectively, while the prevalence among female prisoners was 1.53% (95% CI: 0.31-2.75) and 2.10% (95% CI: 0.28-3.93), respectively. The study findings show a high prevalence of hepatitis B and C in prisoners, which is of particular concern. Appropriate and effective interventions to reduce the transmission of hepatitis B and C in prisons are essential.

Adoption of guidelines on and use of oral pre-exposure prophylaxis: a global summary and forecasting study.

BACKGROUND: In 2016, the UN General Assembly set a global target of 3 million oral pre-exposure prophylaxis (PrEP) users by 2020. With this target at an end, we aimed to assess global trends in the adoption of WHO PrEP recommendations into national guidelines and numbers of PrEP users, defined as people who received oral PrEP at least once in a given year, and to estimate future trajectories of PrEP use. METHODS: In this global summary and forecasting study, data on adoption of WHO PrEP recommendations and numbers of PrEP users were obtained through the Global AIDS Monitoring system and WHO regional offices. Trends in these indicators for 2016-19 by region and for 2019 by country were described, including by gender and priority populations where data were available. PrEP user numbers were forecasted until 2023 by selecting countries with at least 3 years of PrEP user data as example countries in each region to represent possible future PrEP user trajectories. PrEP user growth rates observed in example countries were applied to countries in corresponding regions under different scenarios, including a COVID-19 disruption scenario with static global PrEP use in 2020. FINDINGS: By the end of 2019, 120 (67%) of 180 countries with data had adopted the WHO PrEP recommendations into national guidelines (23 in 2019 and 30 in 2018). In 2019, there were about 626 000 PrEP users across 77 countries, including 260 000 (41·6%) in the region of the Americas and 213 000 (34·0%) in the African region; this is a 69% increase from about 370 000 PrEP users across 66 countries in 2018. Without COVID-19 disruptions, 0·9-1·1 million global PrEP users were projected by the end of 2020 and 2·4-5·3 million are projected by the end of 2023. If COVID-19 disruptions resulted in no PrEP user growth in 2020, the projected number of PrEP users in 2023 is 2·1-3·0 million. INTERPRETATION: Widespread adoption of WHO PrEP recommendations coincided with a global increase in PrEP use. Although the 2020 global PrEP target will be missed, strong future growth in PrEP use is possible. New PrEP products could expand the PrEP user base, and, with greater expansion of oral PrEP, further adoption of WHO PrEP recommendations, and simplified delivery, PrEP could contribute to ending AIDS by 2030. FUNDING: Unitaid, Bill & Melinda Gates Foundation, and WHO.

Control of sexually transmitted infections and global elimination targets, South-East Asia Region.

The World Health Organization (WHO) set targets for a 90% reduction in the incidence of syphilis and gonorrhoea between 2018 and 2030. We review trends in sexually transmitted infections in the WHO South-East Asia Region to assess the feasibility of reaching these targets. Myanmar, Sri Lanka and Thailand reported 90% or greater reductions in the incidence or prevalence of syphilis and/or gonorrhoea between 1975 and 2005. Evidence suggests that smaller, more recent reductions in trends in sexually transmitted infections in India have driven regional declines. In other countries, sexually transmitted infections remain high or are increasing or data are not reliable enough to measure change. Sri Lanka and Thailand have strong control programmes for sexually transmitted infections that ensure universal access to services for these infections and targeted interventions in key populations. India and Myanmar have implemented targeted control efforts on a large scale. Other countries of the region have prioritized control of human immunodeficiency virus, and limited resources are available for other sexually transmitted infections. At national and subnational levels, data show rapid declines in sexually transmitted infections when targeted promotion of condom use and sexually transmitted infection services are scaled up to reach large numbers of sex workers. In contrast, recent outbreaks of sexually transmitted infections in underserved populations of men who have sex with men have been linked to rising trends in sexually transmitted infections in the region. A renewed and focused response to sexually transmitted infections in the region is needed to meet global elimination targets.

L'Organisation mondiale de la Santé (OMS) a fixé des objectifs pour réduire à 90% l'incidence de la syphilis et de la gonorrhée entre 2018 et 2030. Nous avons étudié les tendances en matière d'infections sexuellement transmissibles dans la Région d'Asie du Sud-Est de l'OMS afin d'évaluer la faisabilité de ces objectifs. Le Myanmar, le Sri Lanka et la Thaïlande ont signalé une diminution de 90% ou plus dans l'incidence ou la prévalence de la syphilis et/ou de la gonorrhée entre 1975 et 2005. Les données semblent indiquer une tendance à la baisse plus récente et moins significative des infections sexuellement transmissibles en Inde, entraînant une décrue régionale. Dans d'autres pays, soit le nombre d'infections sexuellement transmissibles demeure élevé ou continue sa progression, soit les informations disponibles ne sont pas suffisamment fiables pour en mesurer l'évolution. Le Sri Lanka et la Thaïlande ont établi de solides programmes de lutte contre les infections sexuellement transmissibles, permettant d'accéder à des services spécialement conçus pour leur prise en charge et prévoyant une intervention ciblée au sein des populations clés. De leur côté, l'Inde et le Myanmar ont déployé des efforts à grande échelle afin de mener des actions ciblées. D'autres pays de la région ont privilégié la lutte contre le virus de l'immunodéficience humaine; pour les autres infections sexuellement transmissibles, leurs ressources sont limitées. Aux niveaux national et infranational, les données révèlent un rapide déclin des infections sexuellement transmissibles lorsque la promotion ciblée pour encourager l'usage du préservatif et les services dédiés à la prise en charge de telles affections sont renforcés afin de toucher un plus grand nombre de travailleurs du sexe. En revanche, les épidémies d'infections sexuellement transmissibles observées dernièrement au sein de populations défavorisées d'hommes ayant des relations sexuelles avec d'autres hommes ont entraîné une hausse dans la région. Il est donc indispensable d'apporter une réponse remaniée et ciblée face aux infections sexuellement transmissibles dans la région en vue d'atteindre les objectifs mondiaux d'élimination.

La Organización Mundial de la Salud (OMS) fijó como objetivo una reducción del 90% en la incidencia de la sífilis y la gonorrea entre 2018 y 2030. Revisamos las tendencias de las infecciones de transmisión sexual en la Región del Sudeste Asiático de la OMS para evaluar la viabilidad de alcanzar estos objetivos. Myanmar, Sri Lanka y Tailandia informaron de reducciones del 90% o más en la incidencia o prevalencia de sífilis y/o gonorrea entre 1975 y 2005. Los datos sugieren que las reducciones más pequeñas y recientes en las tendencias de las infecciones de transmisión sexual en la India han impulsado los descensos regionales. En otros países, las infecciones de transmisión sexual siguen siendo elevadas o están aumentando, o los datos no son lo suficientemente fiables como para medir el cambio. Sri Lanka y Tailandia tienen sólidos programas de control de las infecciones de transmisión sexual que garantizan el acceso universal a los servicios para estas infecciones e intervenciones específicas en poblaciones clave. India y Myanmar han implementado esfuerzos de control específicos a gran escala. Otros países de la región han dado prioridad a la lucha contra el virus de la inmunodeficiencia humana y disponen de recursos limitados para otras infecciones de transmisión sexual. A nivel nacional y subnacional, los datos muestran un rápido descenso de las infecciones de transmisión sexual cuando se amplía la promoción del uso del preservativo y los servicios para las infecciones de transmisión sexual para llegar a un gran número de profesionales del ámbito sexual. Por el contrario, los recientes brotes de infecciones de transmisión sexual en poblaciones desatendidas de hombres que tienen relaciones sexuales con otros hombres se han relacionado con las tendencias al alza de las infecciones de transmisión sexual en la región. Se necesita una respuesta renovada y centrada en las infecciones de transmisión sexual en la región para alcanzar los objetivos mundiales de eliminación.

HIV TB coinfection - perspectives from India.

Introduction: HIV and tuberculosis (TB) are two of the most challenging infections faced by humanity and place immense burden on health care systems worldwide. Both HIV and TB impact one another's progression.Areas covered: HIV is the most important risk factor for progression of latent TB to active disease. TB is the most common cause of death among People Living with HIV (PLHIV). Timely detection of TB among PLHIV and screening for HIV among TB patients, early initiation of ART and ATT among coinfected persons, provision of CPT and TB Preventive therapy along with control of air-borne infection are some of the key activities to reduce morbidity and mortality among coinfected persons. Despite many challenges, the collaboration between two programs has yielded good results and globally more than 7.3 million lives of PLHIV have been saved globally through scale-up of collaborative TB/HIV activities since 2005. The review looked into key features of both programs that are the collaboration strategies and challenges that still need to be addressed.Expert opinion: The overarching principle for effective implementation of collaborative activities is integration of the TB and HIV national programs right from policy making to service delivery and monitoring.

A rapid review of pre-exposure prophylaxis for HIV in the Asia-Pacific region: recommendations for scale up and future directions.

Decline in new HIV infections in the Asia-Pacific region (APAC) continues to be slow, emphasising the importance of scaling up new HIV prevention strategies, such as pre-exposure prophylaxis (PrEP). To help inform PrEP rollout in APAC, we conducted a rapid review of published literature on PubMed from 2015 to 2020, to assess feasibility, implementation strategies, cost-effectiveness, and availability of national policies and guidelines; for the latter, we also did an expanded Internet search. This review focussed on nine countries contributing >95% of new infections in this region. A total of 36 PrEP-related studies conducted among men who have sex with men, female sex workers, and transgender women were included, of which 29 were quantitative, six were qualitative and one was a mixed-method study. Most of the studies have addressed the availability and acceptability of PrEP, whereas cost-effectiveness of any approach was assessed by limited studies. Limited published information was available about national PrEP policies and guidelines; of the selected nine countries, five have adopted the recommended World Health Organization PrEP policy of which four have integrated it in their national HIV response. HIV risk perception concerns about safety, side-effects, stigma, and affordability were major challenges to PrEP acceptance. Community-based implementation has the potential to address these. Limited evidence suggested merging PrEP implementation with ongoing targeted intervention and treatment programs could be a cost-effective approach. To stem the epidemic, newer effective prevention strategies, like PrEP, should be urgently adopted within the context of combination HIV prevention approaches.

Assessing the Effectiveness of a Telemedicine Initiative in Clinical Management of Children Living with HIV/AIDS in Maharashtra, India.

AIMS: To evaluate the effectiveness of telemedicine in the clinical management of children living with HIV/AIDS in resource-limited settings ; Background: Telemedicine is an important mechanism for service delivery in health care settings, both in resource-rich and resource-poor settings. Such service delivery mechanisms have shown to be associated with virologic suppression and higher CD4 counts. These services are also associated with improved access, shorter visiting times, and higher patient satisfaction. ; Objective: We designed the present two-group comparison study to compare the clinical evaluation and management of children in the anti-retroviral therapy (ART) centres linked to telemedicine facility with those who are not linked to this facility in Maharashtra, India. ; Methods: We analysed clinical records from six ART centres in Maharashtra; of these, 250 children were in the linked ART centres and 301 were in the non-linked ART centres. The outcomes were classified according to investigations, management, and monitoring. For management, we evaluated: 1) Initiation of cotrimoxazole prophylaxis; 2) Children not initiated on ART when required; 3) ART regime after appropriate investigations; and 4) Change of regime (if immunologically indicated). For monitoring, we assessed the haematological monitoring of children on ART. ; Results: The mean (SD) ages of children in linked and non-linked ART centres were 10.8 (4.6) and 10.9 (4.6) years, respectively (p=0.80). After adjusting for individual and structural level variables, physical examination (OR: 2.0, 95% CI; 1.2, 3.2), screening for tuberculosis (OR: 12.9, 95% CI: 2.0, 82.9) and cotrimoxazole prophylaxis were significantly more likely in the linked centres compared with non-linked centres (OR: 1.8, 95% CI: 1.4, 2.2). A higher proportion of children eligible for ART were not initiated on treatment in the non-linked centres compared with linked centres (26% vs. 8%, p=0.06). Children were less likely to be initiated on zidovudine-based regimens without baseline haemoglobin or with baseline haemoglobin of less than 9 gm% in linked centres (OR: 0.7, 95% CI: 0.6, 0.8). Similarly, children in the linked centres were less likely to have been started on nevirapine-based regimens without baseline liver enzymes (OR: 0.8, 95% CI: 0.7, 0.9). ; Conclusion: Thus, the overall clinical management of Children Living with HIV/ AIDS (CLHA) was better in ART centres linked with the telemedicine initiative compared with those who were not linked. Children in the linked ART centres were more likely to have a complete baseline assessment (physical, hematological, radiological, and screening for TB); the presence of a pediatrician in the centres was helpful.

Perspectives on voluntary assisted partner notification among providers, people with HIV and the general population in Indonesia: a formative qualitative study.

BACKGROUND: Voluntary assisted partner notification (aPN) services are effective in increasing access to and uptake of HIV testing among partners of people with HIV. Following recommendations by the World Health Organization in 2016, Indonesia evaluated various approaches to aPN. We present the lessons learned from formative operational research undertaken to understand provider and patient perspectives on aPN from three demonstration sites in cities with a high HIV burden. METHODS: We conducted a formative qualitative study in three cities: Jakarta, Semarang, and Denpasar between September and October 2019. We conducted six focus group discussions (FGDs) (n = 44 participants) among health-care providers, people living with HIV and the general population. We explored participant preferences and concerns about how aPN should be delivered, including the methods of and messaging for contacting partners. All FGDs were conducted in the Indonesian language. Qualitative data were analysed using thematic analysis. RESULTS: aPN was acceptable across different participant populations, although with caveats. Some differences were observed between the general population, providers and people living with HIV. People living with HIV were mainly concerned with confidentiality of the procedure and preferred the use of telecommunication and messages that avoid explicit mention of HIV exposure. Providers preferred similar approaches but for different reasons, being concerned mainly with self-efficacy and security. There was consensus regarding dual referral models. The use of phone calls and short messages were preferred as these are perceived to minimize negative reactions and stigma, protect client confidentiality and are suitable in the current legal situation. The general population was mainly concerned with effectiveness and prefer direct provider-led approaches, such as preferring in-person meeting with explicit notification of potential HIV exposure. CONCLUSIONS: We found consensus among stakeholders on acceptance of aPN, especially dual referral methods. Development and implementation of aPN protocols should also consider clients' individual situations and concerns regarding safeguarding of confidentiality, and offer a range of options to accommodate all stakeholders involved.

Community action for people with HIV and sex workers during the COVID-19 pandemic in India.

Sex workers have been one of the marginalized groups that have been particularly affected by India's stringent lockdown in response to the coronavirus disease 2019 (COVID-19) pandemic. The sudden loss of livelihood and lack of access to health care and social protection intensified the vulnerabilities of sex workers, especially those living with HIV. In response, Ashodaya Samithi, an organization of more than 6000 sex workers, launched an innovative programme of assistance in four districts in Karnataka. Since access to antiretroviral therapy (ART) was immediately disrupted, Ashodaya adapted its HIV outreach programme to form an alternative, community-led system of distributing ART at discreet, private sites. WhatsApp messaging was used to distribute information on accessing government social benefits made available in response to the COVID-19 pandemic. Other assistance included advisory messages posted in WhatsApp groups to raise awareness, dispel myths and mitigate violence, and regular, discreet phone check-ins to follow up on the well-being of members. The lessons learnt from these activities represent an important opportunity to consider more sustainable approaches to the health of marginalized populations that can enable community organizations to be better prepared to respond to other public health crises as they emerge.

Impact of COVID-19 on the global supply chain of antiretroviral drugs: a rapid survey of Indian manufacturers.

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.

Trends and Sex Differences in Access to HIV Care with Scale Up of National HIV Treatment Guidelines in Pune, India.

Test and treat is the current global standard, yet sex differences persist in access to HIV care. We assessed the differences in presentation and antiretroviral therapy (ART) uptake by sex and ART-eligibility period among ART-naive adults registered at a public ART center in India. Four ART eligibility periods were defined by programmatically determined CD4 criteria (periods I-IV: CD4 <200, <350, ≤500 cells/µL, and any CD4) between January 2005 and December 2017. Of 23 957 participants, 12 510 were male. Men consistently presented with lower median CD4 count (period I-IV, P < .05) and higher median age (period I-III, P < .001) than women. From period I to IV, median age increased in women (P < .0001), ART initiation time decreased in both sexes (P < .001), and median CD4 remained <200 cells/µL in men. Advanced HIV disease and increasing age at presentation are persistent sex-specific trends which warrant innovative HIV testing strategies in both sexes.

Incidence of tuberculosis in HIV-infected adults on first- and second-line antiretroviral therapy in India.

BACKGROUND: Programmatic data on the baseline risk of tuberculosis in people living with HIV (PLHIV) are needed to evaluate long-term effectiveness of the ongoing isoniazid preventive therapy (IPT) roll-out in India. METHODS: We estimated the incidence rate and risk factors of tuberculosis disease in adult PLHIV initiating first- and second-line anti-retroviral therapy (ART) prior to widespread IPT in a public ART center in Pune, India. RESULTS: 4067 participants contributing 5205.7 person-years of follow-up on first-line ART and 871 participants contributing 1031.7 person-years of follow-up on second-line ART were included in the analysis. The incidence rate of tuberculosis was 4.39 cases (95%CI 3.86-5.00) per 100 person-years on first-line ART and 1.64 cases (95%CI 1.01-2.63) per 100 person-years on second-line ART (p < 0.001). After adjusting for competing risks, male sex (aSHR = 1.33, 95%CI 1.02-1.74, p = 0.03), urban residence (aSHR = 1.53, 95%CI 1.13-2.07, p = 0.006) and CD4+ counts < 350 cells/mm3 (aSHR = 3.06 vs CD4 > 350 cells/mm3, 95%CI 1.58-5.94, p < 0.001) at ART initiation were associated with higher risk of tuberculosis independent of ART regimen. CONCLUSION: Risk of tuberculosis was lower in PLHIV receiving second-line ART compared to first-line ART. Prioritizing IPT in PLHIV with low CD4+ counts, urban residence and in males may further mitigate the risk of tuberculosis during ART.

Quality and effectiveness of counselling at antiretroviral therapy centres in India: capturing counsellor and beneficiary perspectives.

BACKGROUND: Ensuring the quality and effectiveness of counselling is imperative for enabling people living with HIV to cope with treatment adherence. Countrywide assessment of antiretroviral therapy (ART) centres was undertaken to assess the quality and effectiveness of counselling. The insights gained from the assessment are expected to build an improved understanding of the counselling aspect and contribute to informing decisions strengthening the counselling provided at ART centres. METHODS: Assessment of counselling at 357 ART centres entailed interviews with counsellors and beneficiaries using a structured questionnaire administered by trained technical experts. Two counsellors and five beneficiaries at each ART centre were interviewed to assess both the quality and effectiveness of counselling. Beneficiaries were selected from different risk groups to understand their varied concerns and experiences. RESULTS: During the assessment, 618 counsellors were interviewed (45% women); also, 1785 beneficiaries were interviewed, consisting of 892 (49.9%) men, 857 (48.1%) women and 36 (2.0%) transgender. Counsellors were found to be relatively well informed on topics pertaining to pre-ART, ART preparedness and positive healthy living, and the psychosocial support extended to patients. Counsellors surveyed were not aware of critical areas such as counselling of pregnant women (44.5%) , drug adherence (44.8%) and the use of information, education and communication material during counselling, and pill count. The majority of beneficiaries reported being informed on issues pertaining to retention; however, 30-40% of beneficiaries were not informed regarding the critical elements of adherence such as counselling on ART side effects (68.5%), pill count (62.8%) and information on access to social benefit schemes (25.7%). Factors such as client volume, the training of the counsellors and adequate space for counselling affected the quality of counselling. CONCLUSION: With concerted efforts in bridging the gaps in knowledge, infrastructure and information needs, India's national AIDS control programme (NACP) can enhance the counselling services at ART centres and improve the quality of services for patient retention.

Global progress on the elimination of viral hepatitis as a major public health threat: An analysis of WHO Member State responses 2017.

In 2016, the World Health Assembly passed a resolution to eliminate viral hepatitis as a public health threat by 2030. We aimed to examine the status of the global viral hepatitis response. METHODS: In 2017, the World Health Organization (WHO) asked the Ministries of Health in all 194 Member States to complete a Country Profile on Viral Hepatitis policy uptake indicators, covering national plans/funding, engagement of civil society, testing guidance, access to treatment, and strategic information. RESULTS: Of 194 Member States, 135 (70%) responded, accounting for 87% of the global population infected with hepatitis B virus (HBV) and/or C virus (HCV). Of those responding, 84 (62%) had developed a national plan, of which, 49 (58%) had dedicated funding, and 62 (46%) had engaged with civil society; those engaged with civil society were more likely to have a funded plan than others (52% vs. 23%, p = 0.001). Guidance on testing pregnant women (for HBV) and people who inject drugs (for HCV) was available in 70% and 46% of Member States, respectively; 59% and 38% of Member States reported universal access to optimal therapies for HBV and HCV, respectively. CONCLUSIONS: Most people living with hepatitis B and C reside in a country with a national hepatitis strategy. Governments who engaged with civil society were more advanced in their response. Member States need to finance these national strategies and ensure that those affected have access to hepatitis services as part of efforts to achieve universal health coverage. LAY SUMMARY: The World Health Organization's goal to eliminate viral hepatitis as a public health threat by 2030 requires global action. Our results indicate that progress is being made by countries to scale-up national planning efforts; however, our results also highlight important gaps in current policies.

Decreasing cost of public sector first-line ART services in India from 2007-2008 to 2015-2016.

INTRODUCTION: India has scaled-up antiretroviral treatment (ART) in public sector facilities, but data to understand time trends of average cost of ART are limited. MATERIALS AND METHODS: Cost and output data were collected at all public sector ART centres in undivided Andhra Pradesh (high-HIV burden state) and Rajasthan (low-HIV burden state) in India from fiscal year 2007-2008 to 2012-2013. Average cost per patient for first-line ART, and its relation with scale of services, were assessed. Using data on scale of services, the average cost was estimated up to 2015-2016. Break-even point was estimated from average and marginal cost functions. Costs were adjusted to 2015 constant price. RESULTS: The average cost per patient alive and on ART in 2015-2016 was US$162 in undivided Andhra Pradesh and US$186 in Rajasthan, which was 51.4% and 35.8% lower than in 2007-2008, respectively. Average ART drug cost declined by 27.2% during this period, and was 70.9% and 61.5% of the total ART cost in the two states in 2015-2016. The average cost other than ART drugs declined by 73.1% and 45.7%, with the number of patients served increasing 7 and 14.2 times, respectively. Average cost other than ART drugs had a significant negative relation with scale (R2 = 86.4%-82.8%, p<0.001). Break-even analysis suggested that 47.5% and 58.8% of the ART centres in undivided Andhra Pradesh and Rajasthan, respectively, were functioning below optimal scale in 2015-2016. The estimated total economic cost of first-line ART services provided in the public sector in India in fiscal year 2015-2016 was US$ 151 million; it would be US$ 216.1 million to provide this to all eligible persons in India. CONCLUSION: The average cost of providing first-line ART has declined in India, and further reduction is possible if the optimal scale of services is achieved. These findings can inform resource requirement for the ART programme in India.

The cost-effectiveness and budgetary impact of a dolutegravir-based regimen as first-line treatment of HIV infection in India.

INTRODUCTION: Dolutegravir (DTG)-based antiretroviral therapy (ART) is recommended for first-line HIV treatment in the US and Europe. Efavirenz (EFV)-based regimens remain the standard of care (SOC) in India. We examined the clinical and economic impact of DTG-based first-line ART in the setting of India's recent guidelines change to treating all patients with HIV infection regardless of CD4 count. METHODS: We used a microsimulation of HIV disease, the Cost-Effectiveness of Preventing AIDS Complications (CEPAC)-International model, to project outcomes in ART-naive patients under two strategies: (1) SOC: EFV/tenofovir disoproxil fumarate (TDF)/lamivudine (3TC); and (2) DTG: DTG + TDF/3TC. Regimen-specific inputs, including virologic suppression at 48 weeks (SOC: 82% vs. DTG: 90%) and annual costs ($98 vs. $102), were informed by clinical trial data and other sources and varied widely in sensitivity analysis. We compared incremental cost-effectiveness ratios (ICERs), measured in $/year of life saved (YLS), to India's per capita gross domestic product ($1600 in 2015). We compared the budget impact and HIV transmission effects of the two strategies for the estimated 444,000 and 916,000 patients likely to initiate ART in India over the next 2 and 5 years. RESULTS: Compared to SOC, DTG improved 5-year survival from 76.7% to 83.0%, increased life expectancy from 22.0 to 24.8 years (14.0 to 15.5 years, discounted), averted 13,000 transmitted HIV infections over 5 years, increased discounted lifetime care costs from $3040 to $3240, and resulted in a lifetime ICER of $130/YLS, less than 10% of India's per capita GDP in 2015. DTG maintained an ICER below 50% of India's per capita GDP as long as the annual three-drug regimen cost was ≤$180/year. Over a 2- or 5-year horizon, total undiscounted outlays for HIV-related care were virtually the same for both strategies. CONCLUSIONS: A generic DTG-based regimen is likely to be cost-effective and should be recommended for initial therapy of HIV infection in India.