Cost-effectiveness and economic investment to eliminate chronic hepatitis C in Mexico.

In July 2020, the Mexican Government initiated the National Program for Elimination of Hepatitis C (HCV) under a procurement agreement, securing universal, free access to HCV screening, diagnosis and treatment for 2020-2022. This analysis quantifies the clinical and economic burden of HCV (MXN) under a continuation (or end) to the agreement. A modelling and Delphi approach was used to evaluate the disease burden (2020-2030) and economic impact (2020-2035) of the Historical Base compared to Elimination, assuming the agreement continues (Elimination-Agreement to 2035) or terminates (Elimination-Agreement to 2022). We estimated cumulative costs and the per-patient treatment expenditure needed to achieve net-zero cost (the difference in cumulative costs between the scenario and the base). Elimination is defined as a 90% reduction in new infections, 90% diagnosis coverage, 80% treatment coverage and 65% reduction in mortality by 2030. A viraemic prevalence of 0.55% (0.50-0.60) was estimated on 1st January 2021, corresponding to 745,000 (95% CI 677,000-812,000) viraemic infections in Mexico. The Elimination-Agreement to 2035 would achieve net-zero cost by 2023 and accrue 31.2 billion in cumulative costs. Cumulative costs under the Elimination-Agreement to 2022 are estimated at 74.2 billion. Under Elimination-Agreement to 2022, the per-patient treatment price must decrease to 11,000 to achieve net-zero cost by 2035. The Mexican Government could extend the agreement through 2035 or reduce the cost of HCV treatment to 11,000 to achieve HCV elimination at net-zero cost.

Hepatitis C Among People Who Inject Drugs (PWID) in Latin America and the Caribbean: A Meta-Analysis of Prevalence Over Three Decades.

OBJECTIVE: People who inject drugs (PWID) are known to be more susceptible to infections such as hepatitis C virus (HCV). This systematic review and meta-analysis aimed to estimate the prevalence of hepatitis C among PWID in Latin America and the Caribbean (LAC). METHOD: The MEDLINE, Embase, and LILACS databases were searched without language restriction from inception to 2021. Articles were screened based on titles and abstracts. After reading the full texts, the articles were selected based on eligibility criteria. RESULTS: Of the 486 identified publications, 123 full texts were assessed, and 23 studies with a mean quality score of 7.2 were included. A total of 11,419 PWID were included in the meta-analysis, and the estimated overall prevalence of hepatitis C among PWID in LAC was 57.0%, which was higher than the United Nations Office on Drugs and Crime global prevalence of 50.2%. In meta-analyses of subgroups divided according to the risk of exposure to HCV infection (in addition to the imminent risk of injected drugs), the estimated prevalence of hepatitis C in PWID in the lowerrisk population (general) was 57.0%. The prevalence of hepatitis C in PWID who were infected with HIV was 61.0%. The estimated hepatitis C prevalence was also assessed for three periods: in 1991-2000, it was 59.0%; in 2001-2010, it was 63.0%; and in 2011-2020, it was 48.0%. CONCLUSIONS: The high estimated prevalence of hepatitis C in LAC reinforces the need for increased diagnostic efforts, strategies for treating drug addiction and hepatitis C, and harm reduction policies that target PWID.

Sofosbuvir+velpatasvir+voxilaprevir para o retratamento da hepatite C crônica em pacientes com ou sem cirrose compensada / Sofosbuvir+velpatasvir+voxilaprevir for the retreatment of chronic hepatitis C in patients with or without compensated cirrhosis

INTRODUÇÃO: O vírus da hepatite C (HCV) contempla ao menos sete genótipos diferentes e 67 subtipos de vírus. A hepatite C crônica é uma doença de caráter insidioso e se caracteriza por um processo inflamatório persistente. Na ausência de tratamento, há cronificação em 60% a 85% dos casos e, em média, 20% evoluem para cirrose. Na vigência da cirrose hepática, o risco anual para evolução para carcinoma hepatocelular é de 1% a 5%. Estimase que cerca de 58 milhões de pessoas estejam infectadas pelo HCV, com a doença crônica, em todo o mundo e, cerca de 400 mil por ano morrem devido a complicações da doença, principalmente em decorrência da cirrose. No Brasil estima-se prevalência de 0,7%, correspondendo a cerca de 700 mil casos na faixa etária de 15 a 69 anos, até o ano de 2016. Entre os anos 2000 e 2021, foram notificados no Brasil 279.872 casos confirmados de hepatite C. O medicamento desta demanda engloba os inibidores pangenotípico da RNA polimerase NS5B (sofosbuvir), da proteína NS5A (velpatasvir) e da protease NS3/4A (voxilaprevir) para retratar pacientes que não alcançaram resposta virológica sustentada com os tratamentos disponibilizados no SUS. PERGUNTA DE PESQUISA: Vosevi®(sofosbuvir/velpatasvir/voxilaprevir) é eficaz, seguro e economicamente viável para o tratamento de pacientes com hepatite C crônica sem cirrose ou com cirrose compensada (Child-Pugh A), para todos os genótipos (1 a 6) que tenham sido previamente tratados com antiviral de ação direta com um regime contendo ou não um inibidor de NS5A? EVIDÊNCIAS CLÍNICAS: : O demandante realizou as buscas na literatura utilizando as seguintes bases de dados: The Cochrane Library, Medline via PubMed, Literatura Latino-Americana e do Caribe em Ciências da Saúde (LILACS), Centre for Reviews and Dissemination (CRD), e resultou na inclusão de 3 publicações. Na análise conduzida pela Secretaria Executiva foram consideradas 2 publicações referentes a um ensaio clínico randomizado. O estudo POLARIS-1 comparou SOF/VEL/VOX com placebo, incluiu 415 pacientes com hepatite C, previamente tratados, sem cirrose ou com cirrose compensada. A proporção de pacientes que alcançaram resposta virológica sustentada (RVS) em 12 semanas de tratamento foi de 96,2% (IC 95% 93,1 a 98,2) no grupo que recebeu a intervenção. Os pacientes que receberam placebo na primeira fase do estudo, posteriormente receberam a intervenção, compondo a subanálise do estudo, que contemplou 143 pacientes. A RVS foi alcançada por 97% dos pacientes (IC 95% 93 a 99). No grupo que recebeu SOF/VEL/VOX, 78% dos pacientes tiveram pelo menos um evento adverso (EA), sendo os mais frequentes: cefaleia (25%), fadiga (21%), diarreia (18%) e náusea (14%). A maioria dos EA foram graus 1 e 2 (leve ou moderado). EA grau 3 ou grau 4 foram reportados em cinco pacientes (1,9%) no grupo SOF/VEL/VOX e em quatro pacientes (2,6%) no grupo placebo. Um total de cinco pacientes (1,9%) tiveram EA grave no grupo SOF/VEL/VOX e sete pacientes (4,6%) no grupo placebo. Não houve registro de mortes durante o estudo. AVALIAÇÃO ECONÔMICA: O demandante apresentou uma análise de custo-minimização utilizando como comparador o tratamento atualmente recomendado no SUS por meio do Ofício Circular nº 6/2022/CGAHV/DCCI/SVS/MS, glecaprevir/pibrentasvir com ou sem ribavirina. Com base nos valores de compras públicas, preço do medicamento SOF/VEL/VOX publicado pela CMED, e o tempo de tratamento de cada um dos medicamentos, o tratamento com SOF/VEL/VOX resultou em economia de R$ 336,84 por paciente, quando comparado com glecaprevir/pibrentasvir, e economia de R$ 1.232,84 por paciente se comparado com glecaprevir/pibrentasvir + ribavirina. ANÁLISE DE IMPACTO ORÇAMENTÁRIO: O demandante comparou os custos atuais do tratamento glecaprenvir/pibrentasvir ± ribavirina com SOF/VEL/VOX. O demandante estimou um total de 2.129 pacientes elegíveis para 2022, e 1.362 pacientes para 2026. A Secretaria-Executiva com o apoio da Coordenação-Geral de Vigilância do HIV/Aids e das hepatites virais utilizou dados mais condizentes com a realidade e assim estimou a população mínimia e máxima elegível. Com base nos dados e no market-share proposto pelo demandante, a incorporação de SOF/VEL/VOX geraria economia de recursos equivalente a aproximadamente R$ 569 mil no primeiro ano de incorporação, totalizando economia de aproximadamente R$ 4,7 milhões no acumulado de cinco anos. Com a população recalculada, a economia seria de aproximadamente R$ 1,3 milhões ou aproximadamente R$ 934 mil em 5 anos, considerando a população mínima ou máxima respectivamente. MONITORAMENTO DO HORIZONTE TECNOLÓGICO: Não foram identificados medicamentos em desenvolvimento ou estudos clínicos em andamento com novos medicamentos para o retratamento de hepatite C crônica sem cirrose ou com cirrose compensada. CONSIDERAÇÕES FINAIS: Os resultados do ensaio clínico sugerem que o tratamento com sofosbuvir/velpatasvir/voxilaprevir é eficaz e seguro no retratamento da hepatite C na população elegível. No estudo de custo-minimização o tratamento mostrou-se mais econômico em comparação ao tratamento atualmente disponibilizado no SUS. Na análise do impacto orçamentário, a incorporação do medicamento resultaria em economia de recursos, desde que o demandante mantenha o valor proposto. RECOMENDAÇÃO PRELIMINAR DA CONITEC: Os membros do Plenário presentes na 112ª Reunião Ordinária da Conitec, realizada no dia 01 de setembro de 2022, sem nenhuma declaração de conflito de interesse, deliberaram por unanimidade, encaminhar o tema para consulta pública com recomendação preliminar favorável à incorporação de sofosbuvir/velpatasvir/voxilaprevir para o retratamento de pacientes com hepatite C crônica, sem cirrose ou com cirrose compensada (Child-Pugh A), infectados por vírus com genótipos 1 a 6, previamente tratados com antivirais de ação direta (DAAs), com ou sem inibidor de NS5A. Os membros consideraram a evidência científica suficiente e favorável à tecnologia, mostrou-se econômica, tanto na análise de custo-minimização, quanto no impacto orçamentário, e será mais uma opção de tratamento, junto com glecaprevir/pibrentasvir, gerando assim, concorrência de mercado e acesso. CONSULTA PÚBLICA: Entre os dias 23/09/2022 e 13/10/2022 foram recebidas 32 contribuições, sendo sete pelo formulário para contribuições técnico-científicas e 25 pelo formulário para contribuições sobre experiência ou opinião de pacientes, familiares, amigos ou cuidadores de pacientes, profissionais de saúde ou pessoas interessadas no tema. Todos foram a favor da incorporação de sofosbuvir+velpastavir+voxilaprevir no SUS. O principal benefício apontado nas contribuições técnico-científicas versaram sobre a eficácia, tolerância ao tratamento, comodidade posológica, qualidade de vida dos pacientes, alternativa terapêutica, e economia de recursos. Não houve nenhum acréscimo de dados de evidência clínica, atualização na avaliação econômica ou impacto orçamentário. A empresa detentora do registro do medicamento reforçou seu compromisso em manter o preço teto de R$ 334,27 por comprimido, o qual representa um desconto de 79% sobre o PMVG 18%. Nas contribuições de experiência e opinião, um formulário foi excluído por não se tratar da tecnologia em análise. Assim, dos 24 participantes elegíveis, todos se manifestaram em acordo com a decisão preliminar da Conitec. Para demonstrar opinião favorável à incorporação dos medicamentos, os respondentes argumentaram a importância de garantir acesso aos medicamentos a todos; a importância dele para a recuperação dos pacientes; a alta taxa de resposta. Em relação à experiência com o medicamento, os participantes indicaram, entre os efeitos positivos do uso do medicamento, o aumento na qualidade de vida dos pacientes; a alta taxa de resposta e recuperação total dos pacientes. A experiência com outras tecnologias indicou outros medicamentos que têm condições e efeitos parecidos aos medicamentos avaliados, como ledispavir e daclatasvir. Apenas para o interferon foram destacados efeitos negativos relacionados aos efeitos colaterais. RECOMENDAÇÃO FINAL DA CONITEC: Os membros do Plenário da Conitec, em sua 114ª Reunião Ordinária, realizada no dia nove de novembro de 2022, deliberaram por unanimidade, recomendar a incorporação no SUS do sofosbuvir+velpastavir+voxilaprevir para o retratamento de pacientes com hepatite C crônica, sem cirrose ou com cirrose compensada (Child-Pugh A), infectados por vírus com genótipos 1 a 6, previamente tratados com antivirais de ação direta, com inibidor NS5A, conforme protocolo estabelecido pelo Ministério da Saúde. Foi assinado o Registro de Deliberação nº 779/2022. DECISÃO: Incorporar, no âmbito do Sistema Único de Saúde - SUS, o sofosbuvir + velpatasvir + voxilaprevir para o retratamento de pacientes com hepatite C crônica, sem cirrose ou com cirrose compensada (Child-Pugh A), infectados por vírus com genótipos 1 a 6, previamente tratados com antivirais de ação direta (DAAs), com inibidor de NS5A, conforme protocolo estabelecido pelo Ministério da Saúde, conforme a Portaria nº 163, publicada no Diário Oficial da União nº 226, seção 1, página 217, em 2 de dezembro de 2022.

Prevalence of hepatitis C virus infection in patients with end-stage renal disease in Latin America and the Caribbean: a systematic review and meta-analysis.

AIM: To estimate the prevalence of hepatitis C virus (HCV) infection in patients with end-stage renal disease (ESRD) undergoing hemodialysis in Latin America and the Caribbean (LAC). MATERIALS AND METHODS: Observational studies published in Spanish, Portuguese, and English language by November 25, 2021, in PubMed, Embase, Web of Science, Scopus, SciELO, and LILACS were selected by two reviewers according to predefined eligibility criteria. Study quality was assessed using the US National Heart, Lung and Blood Institute tool for observational cohort and cross-sectional studies. A meta-analysis of proportions was performed using a random-effects model based on the DerSimonian and Laird method, using R. PROSPERO N°: CRD42018107403. RESULTS: A total of 20 studies were included in the narrative synthesis (15 from Brazil, two from Cuba, two from Argentina, and one from Peru). Only 17 studies were included in the meta-analysis (13 from Brazil, two from Argentina, one from Cuba, and one from Peru). The overall prevalence of HCV in ESRD patients undergoing hemodialysis in LAC was 11.3% (95% confidence interval [CI]: 8.9% - 13.9%; I2: 99 %). In Brazil and Argentina, the prevalence was 6% and 26.1%, respectively. Prevalence after excluding poor-quality studies was 10.7%. CONCLUSION: The prevalence of HCV in ESRD patients undergoing hemodialysis in LAC was 11.3%. The implementation of infection control measures in hemodialysis centers in LAC is required. It is also necessary to increase the number of studies on the subject in the ESRD population in most LAC countries.

Persistently high hepatitis C rates in haemodialysis patients in Brazil [a systematic review and meta-analysis].

We conducted a systematic review and meta-analysis of studies assessing HCV infection rates in haemodialysis patients in Brazil (Prospero CRD #42021275068). We included studies on patients under haemodialysis, comprising both convenience samples and exhaustive information from selected services. Patients underwent HCV serological testing with or without confirmation by HCV RNA PCR. Exclusion criteria were the following: absence of primary empirical information and studies without information on their respective settings, study year, accurate infection rates, or full specification of diagnostic tests. Studies with samples ≤ 30 and serial assessments with repeated information were also excluded. Reference databases included PubMed, LILACS, Scopus, and Web of Science for the period 1989-2019. A systematic review was carried out, followed by two independent meta-analyses: (i) studies with data on HCV prevalence and (ii) studies with a confirmatory PCR (i.e., active infection), respectively. A comprehensive set of different methods and procedures were used: forest plots and respective statistics, polynomial regression, meta-regression, subgroup influence, quality assessment, and trim-and-fill analysis. 29 studies and 11,290 individuals were assessed. The average time patients were in haemodialysis varied from 23.5 to 56.3 months. Prevalence of HCV infection was highly heterogeneous, with a pronounced decrease from 1992 to 2001, followed by a plateau and a slight decrease in recent years. The summary measure for HCV prevalence was 34% (95% CI 26-43%) for studies implemented before 2001. For studies implemented after 2001, the corresponding summary measure was 11% (95% CI 8-15%). Estimates for prevalence of active HCV infection were also highly heterogeneous. There was a marked decline from 1996 to 2001, followed by a plateau and a slight increase after 2010. The summary measure for active HCV infection was 19% (95% CI 15-25%) in studies carried out before 2001. For studies implemented after 2001, the corresponding summary measure was 9% (95% CI 6-13%). Heterogeneity was pervasive, but different analyses helped to identify its underlying sources. Besides the year each study was conducted, the findings differed markedly between geographic regions and were heavily influenced by the size of the studies and publication biases. Our systematic review and meta-analysis documented a substantial decline in HCV prevalence among Brazilian haemodialysis patients from 1992 to 2015. CKD should be targeted with specific interventions to prevent HCV infection, and if prevention fails, prompt diagnosis and treatment. Although the goal of HCV elimination by 2030 in Brazil remains elusive, it is necessary to adopt measures to achieve micro-elimination and to launch initiatives towards targeted interventions to curb the spread of HCV in people with CKD, among other high-risk groups. This is of particular concern in the context of a protracted COVID-19 pandemic and a major economic and political crisis.

Prevalence of hepatitis B, C, and D virus infection in Haiti: A systematic review and meta-analysis.

Background: Viral hepatitis causes an important global health burden. In 2016, the World Health Assembly adopted an objective to globally eliminate this as a public health threat by 2030. However, significant gaps exist between countries in their progress. Haiti is the last country that has introduced infant hepatitis B vaccines into the routine immunization program in the Region of the Americas, and its schedule still does not incorporate birth dose vaccines. As the first step to raise awareness of viral hepatitis in this country, we conducted a systematic review and meta-analysis to estimate the prevalence of hepatitis B (HBV), C (HCV), and D (HDV) viruses in Haiti. Methods: We searched PubMed, EMBASE, Web of Science and Scopus for studies reporting the prevalence of HBV, HCV and HDV among Haitian, with no language restriction, published until November 30th, 2021. Prevalence was pooled via a random-effects meta-analysis using a generalized linear mixed model with the logit link. Results: Of 453 articles retrieved, 25 studies were included: 16 reported the prevalence of hepatitis B surface antigen (HBsAg), three for anti-HCV antibody, and six for both HBsAg and anti-HCV. No study was found for HDV prevalence. The pooled prevalence of HBsAg was 0.7% [95% confidence interval (CI): 0.3-1.4, I 2 = 77.7%] among children, 3.5% (95% CI: 2.8-4.4, I 2 = 93.2%) in the general adult population and 7.4% (95% CI: 4.0-13.3, I 2 = 83.9%) in high-risk adult population. The pooled prevalence of anti-HCV antibody was 0.9% (95% CI: 0.6-1.4, I 2 = 93.5%) among the general population and 1.4% (95% CI: 0.4-4.2, I 2 = 0.0%) in high-risk adult population. No study reported the prevalence of anti-HCV antibody exclusively in children. Interpretation: The prevalence of blood-borne hepatitis, particularly that of HBV, is substantial in Haiti. The introduction of birth dose hepatitis B vaccines and improving access to testing and treatment services should be urgently considered to meet the elimination goal. Systematic review registration: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022298081, identifier: PROSPERO (CRD42022298081).

Tratamento farmacológico para Hepatite C: a incorporação dos antivirais de ação direta pelo Sistema Único de Saúde de 2012 a 2021 / Pharmacological treatment for Hepatitis C: the incorporation of direct-acting by the Unified Health System from 2012 to 2021

A erradicação do vírus da hepatite C (HCV), por meio de tratamento farmacológico, é a única intervenção que pode deter a progressão dessa doença. Os antivirais de ação direta (AAD) de segunda geração respondem por altas taxas de cura em terapias seguras e totalmente orais. No Brasil, diferentes AAD vêm sendo ofertados no Sistema Único de Saúde (SUS), a partir das recomendações da Comissão Nacional de Incorporação de Tecnologias no Sistema Único de Saúde (CONITEC) e mediante critérios de inclusão do Protocolo Clínico e Diretrizes Terapêuticas (PCDT) para hepatite C. Essa dissertação tem como objetivo analisar a dinâmica de incorporação e a efetividade da oferta dos AAD para tratamento da hepatite C no SUS, de 2012 a 2021. Foram realizadas análises documentais dos relatórios de recomendação da CONITEC e das atualizações de PCDT, além de busca nos bancos de dados do Ministério da Saúde sobre compras federais e sobre a dispensação dos medicamentos incorporados na produção ambulatorial do SUS. Dez tratamentos antivirais, compreendendo quinze AAD, foram incorporados ao SUS e, dentre eles, quatro tratamentos antivirais foram posteriormente excluídos no período estudado. Os AAD foram rapidamente demandados à CONITEC para análise de incorporação logo após seus registros na Agência Nacional de Vigilância Sanitária (ANVISA), sendo todos de comercialização global recente e com pouca experiência acumulada de uso. O tempo de conclusão do processo administrativo da CONITEC foi sempre inferior ao prazo máximo legal, com tempo de consulta pública abreviado algumas vezes e sem audiência pública. Essa celeridade, entretanto, esbarra no intervalo entre a incorporação dos AAD e a primeira dispensação no SUS, com média de tempo maior que o prazo legal para a oferta na rede de atenção. Em diversas situações, atrasos na primeira compra pública regular efetuada pelo Ministério da Saúde contribuíram para esses prazos. Incorporada em 2018 e presente no PCDT vigente, a associação elbasvir/grazoprevir não possui registros de compra ou dispensação, conferindo uma situação em que as alternativas terapêuticas permanecem incorporadas e poderiam participar de futuras negociações de preço, conforme critérios de custo-minimização ou de simplificação do tratamento por capacidade pangenotípica. Sinaliza-se que a dinâmica de incorporação e exclusão dos AAD, embora baseada em critérios científicos, pode admitir outras interferências, sejam financeiras ou políticas. O tratamento tornou-se mais simples a partir dos tratamentos pangenotípicos e o país pôde passar a dispensar os AAD na rede de atenção primária, com vistas a melhorar questões de acesso universal ao tratamento.

Eradication of hepatitis C virus (HCV) through pharmacological treatment is the only intervention that can halt the progression of hepatitis C. Second-generation direct-acting antivirals (DAA) account for high cure rates in safe therapies and fully oral. In Brazil, different DAA have been offered in the Unified Health System (SUS), based on the recommendations of the National Commission for the Incorporation of Technologies in the Unified Health System (CONITEC) and through the inclusion criteria of the Clinical Protocol and Therapeutic Guidelines (PCDT) for hepatitis C. This dissertation aims to analyze the dynamics of incorporation and the effectiveness of the offer of DAA for the treatment of hepatitis C in the SUS, from 2012 to 2021. Documentary analyzes of the CONITEC recommendation reports and the PCDT updates were carried out, in addition to a search in the Ministry of Health databases on federal purchases and on the dispensing of medicines incorporated in he SUS outpatient production. Ten antiviral treatments, comprising fifteen DAA, were incorporated into the SUS and, among them, four antiviral treatments were excluded during the study period. The DAA were quickly requested to CONITEC for analysis of incorporation soon after their registration with the National Agency for Sanitary Surveillance (ANVISA), all of them being very recent global marketing and with little accumulated experience of use. The time taken to complete the CONITEC administrative process was always shorter than the maximum legal deadline, with public consultation time shortened a few times and without a public hearing. This speed, however, comes up against the interval between the incorporation of the DAA and the first dispensation in the SUS, with an average time longer than the legal deadline for offering them in the care network. In several situations, delays in the first regular public purchase made by the Ministry of Health contributed to these deadlines. Incorporated in 2018 and present in the current PCDT, the elbasvir/grazoprevir association does not have purchase or dispensing records, giving a situation in which therapeutic alternatives remain incorporated and could participate in future price negotiations, according to cost-minimization or simplification criteria of treatment by pangenotypic capacity. It is pointed out that the dynamics of incorporation and exclusion of DAA, although based on scientific criteria, can admit other interferences, whether financial or political. Treatment became simpler with pangenotypic treatments and the country was able to start to dispense DAA in the primary care network, improving universal access to treatment.

Hepatitis B prevalence in Brazilian waste pickers: a systematic review with meta-analysis.

OBJECTIVE: To describe the hepatitis B prevalence in Brazilian waste pickers. METHODS: We performed a literature search in the SciELO, Biblioteca Virtual em Saúde (BVS), PubMed and Web of Science databases using the descriptors: "hepatitis B" AND ("informal recycling" OR "waste picker" OR "recyclable waste collectors" OR "solid waste segregator") AND ("recyclable waste" OR "solid waste") AND Brazil. Epidemiological studies on HBV in Brazilian waste pickers published prior to February 2020 were included and evaluated for quality and bias using a funnel plot. RESULTS: This meta-analysis consisted of five articles. Prevalence of HBV surface antigen seropositivity was 14% (95%CI: 6%-22%) in Brazilian waste pickers. CONCLUSION: HBV prevalence in Brazilian waste pickers remains high. There should be more campaigns showing the importance of vaccination and personal protective equipment use.

Cost-Minimization and Budget Impact Analysis of a Hexavalent Vaccine (Hexaxim®) in the Colombian Expanded Program on Immunization.

OBJECTIVES: To evaluate cost implications of a hexavalent vaccine (diphtheria, tetanus, and acellular pertussis [DTaP]-inactivated polio vaccine [IPV]-hepatitis B [HB]-Haemophilus influenzae type B [Hib] polysaccharide conjugated to T protein [PRP∼T]) as an alternative to DT-whole-cell pertussis (wP)-HB//Hib, DTwP, IPV, and oral polio vaccines in the Expanded Program on Immunization schedule in Colombia. METHODS: Primary vaccination (DTaP-IPV-HB-PRP∼T or DTwP-HB-Hib + IPV [2, 4, 6 months]) and booster (DTaP-IPV-HB-PRP∼T or DTwP + oral polio vaccine [18 months]) (scenario 1) and primary vaccination only (DTaP-IPV-HB-PRP∼T or DTwP-HB-Hib + IPV) (scenario 2) were evaluated. An estimated cost-minimization analysis was based on a micro costing technique for vaccination-associated activities. Adverse event (AE)-associated costs, out-of-pocket costs, and productivity losses for caregivers were included. A budget impact (12-month temporal horizon) was estimated according to the distribution of full-term and premature infants. A 5% annual discount rate was used. A 2-way univariate (tornado) analysis evaluated which variables had the greatest impact on the overall cost. RESULTS: DTaP-IPV-HB-PRP∼T resulted in a cost increase of 29.38% (scenario 1) and 22.19% (scenario 2) for full-term infants and a decrease of 0.99% (scenario 1) and 18.88% (scenario 2) for premature infants, probably because of the higher incidence of wP-related AEs and associated costs in premature infants. With a 100% replacement rate, the budget impact for full-term infants and full-term plus premature infants was 23.73% and 21.80% (scenario 1), respectively, and 13.02% and 11.14% (scenario 2), respectively, of the national immunization program budget. The variables with most impact were the hexavalent vaccine price and costs associated with the pentavalent safety profile. CONCLUSIONS: Incorporation of the hexavalent vaccine in the Expanded Program on Immunization schedule would lead to an increase in spending largely mitigated by reduced AE incidence and reduced logistic and social costs.

Systematic Review of Hepatitis E Virus in Brazil: A One-Health Approach of the Human-Animal-Environment Triad.

Brazil is the fifth largest country in the world with diverse socioeconomic and sanitary conditions, also being the fourth largest pig producer in the world. The aim of the present systematic review was to collect and summarize all HEV published data from Brazil (from 1995 to October 2020) performed in humans, animals, and the environment, in a One Health perspective. A total of 2173 papers were retrieved from five search databases (LILACs, Mendeley, PubMed, Scopus, and Web of Science) resulting in 71 eligible papers after application of exclusion/inclusion criteria. Data shows that HEV genotype 3 (HEV-3) was the only retrieved genotype in humans, animals, and environment in Brazil. The South region showed the highest human seroprevalence and also the highest pig density and industry, suggesting a zoonotic link. HEV-1 and 2 were not detected in Brazil, despite the low sanitary conditions of some regions. From the present review we infer that HEV epidemiology in Brazil is similar to that of industrialized countries (only HEV-3, swine reservoirs, no waterborne transmission, no association with low sanitary conditions). Hence, we alert for the implementation of HEV surveillance systems in swine and for the consideration of HEV in the diagnostic routine of acute and chronic hepatitis in humans.

Telemedicine, time to change the paradigm of hepatitis C management: improve access and reduce costs In reference to: Chronic viral hepatitis C micro-elimination program using telemedicine. The Mexican experience, by Pérez Hernández et al.

Hepatitis C (HCV) management has dramatically changed with the advent of direct-acting antivirals. Their high efficacy and safety are changing the paradigm of detection and treatment of patients with an active HCV infection. Following the latest guidelines, the path to elimination of hepatitis C will be achieved by simplifying management.

Cost-effectiveness of hepatitis C virus (HCV) elimination strategies among people who inject drugs (PWID) in Tijuana, Mexico.

BACKGROUND AND AIMS: In Latin America, Mexico was first to launch a hepatitis C virus (HCV) elimination strategy, where people who inject drugs (PWID) are a main risk group for transmission. In Tijuana, HCV seroprevalence among PWID is > 90%, with minimal harm reduction (HR). We evaluated cost-effectiveness of strategies to achieve the incidence elimination target among PWID in Tijuana. METHODS: Modeling study using a dynamic, cost-effectiveness model of HCV transmission and progression among active and former PWID in Tijuana, to assess the cost-effectiveness of incidence elimination strategies from a health-care provider perspective. The model incorporated PWID transitions between HR stages (no HR, only opioid agonist therapy, only high coverage needle-syringe programs, both). Four strategies that could achieve the incidence target (80% reduction by 2030) were compared with the status quo (no intervention). The strategies incorporated the number of direct-acting anti-viral (DAA) treatments required with: (1) no HR scale-up, (2) HR scale-up from 2019 to 20% coverage among PWID, (3) HR to 40% coverage and (4) HR to 50% coverage. Costs (2019 US$) and health outcomes [disability-adjusted life years (DALYs)] were discounted 3% per year. Mean incremental cost-effectiveness ratios (ICER, $/DALY averted) were compared with one-time per capita gross domestic product (GDP) ($9698 in 2019) and purchasing power parity-adjusted per capita GDP ($4842-13 557) willingness-to-pay (WTP) thresholds. RESULTS: DAAs alone were the least costly elimination strategy [$173 million, 95% confidence interval (CI) = 126-238 million], but accrued fewer health benefits compared with strategies with HR. DAAs + 50% HR coverage among PWID averted the most DALYs but cost $265 million, 95% CI = 210-335 million). The optimal strategy was DAAs + 50% HR (ICER $6743/DALY averted compared to DAAs only) under the one-time per-capita GDP WTP ($9698). CONCLUSIONS: A combination of high-coverage harm reduction and hepatitis C virus treatment is the optimal cost-effective strategy to achieve the HCV incidence elimination goal in Mexico.

The challenges of administering a new treatment: the case of direct-acting antivirals for hepatitis C virus.

OBJECTIVES: We develop a patient prioritization scheme for treating patients infected with hepatitis C virus (HCV) and study under which scenarios it outperforms the current practices in Spain and Chile. STUDY DESIGN: We use simulation to evaluate the performance of prioritization rules under two HCV patient cohorts, constructed using secondary data of public records from Chile and Spain, during 2015-2016. METHODS: We use the results of a mathematical model, which determines individual optimal HCV treatment policies as an input for constructing a patient prioritization rule, when limited resources are present. The prioritization is based on marginal analysis on cost increases and health-outcome gains. We construct the Chilean and Spanish case studies and used Monte Carlo simulation to evaluate the performance of our methodology in these two scenarios. RESULTS: The resulting prioritizations for the Chilean and Spanish patients are similar, despite the significant differences of both countries, in terms of epidemiological profiles and cost structures. Furthermore, when resources are scarce compared with the number of patients in need of the new drug, our prioritization significantly outperforms current practices of treating sicker patients first, both in terms of cost and healthcare indicators: for the Chilean case, we have an increase in the quality-adjusted life years (QALYs) of 0.83 with a cost reduction of 8176 euros per patient, with a budget covering 2.5% of the patients in the cohort. This difference slowly decreases when increasing the available resources, converging to the performance indicators obtained when all patients are treated immediately: for the Spanish case, we have a decrease in the QALYs of 0.17 with a cost reduction of 1134 euros per patient, with a budget covering 20% of the patients in the cohort. CONCLUSION: Decision science can provide useful analytical tools for designing efficient public policies that can excel in terms of quantitative health performance indicators.

Hepatitis B or C prevalence in waste pickers from South America: a systematic review.

BACKGROUND: Waste pickers are considered a vulnerable population at risk for potential health damage. Taking into account the risk of hepatitis B or C infection in this population, the aim of this study was to show the prevalence of these diseases in waste pickers from South America, through a systematic review. METHODS: The search covered publications until February 2020, accessed through Google Scholar database. Epidemiological studies on hepatitis B or C focused on waste pickers in South America were included. All selected papers were evaluated for quality. RESULTS: Six studies composed this systematic review, all conducted in Brazil and using cross-sectional study. The prevalence of all makers (HBsAg or anti-HBc) for hepatitis B varied from 4.3 to 33.4% while for hepatitis C varied from 1.6 to 12.4%. CONCLUSION: The lack of results showed the requirement for more research about hepatitis including this informal workers group. High prevalences of hepatitis B and C in waste pickers highlighted the need of increase preventive health protection as vaccination against hepatitis B; training on working conditions; and the use of individual protection.

A comprehensive update of the status of hepatitis C virus (HCV) infection in Mexico-A systematic review and meta-analysis (2008-2019).

INTRODUCTION AND OBJECTIVES: HCV infection is targeted by the WHO's Global Health Sector Strategy on Viral Hepatitis to be reduced notably by 2030. However, renovated epidemiological data is needed to line up with such goals. Herein, we provide an updated review of incidence, prevalence, genotypes (GTs), and risk factors (RFs) of HCV infection in Mexico to build elimination strategies. MATERIAL AND METHODS: HCV incidence was charted using the cumulative new cases/year at week 52. Prevalence, GTs, and RFs data from low-risk (LR-G) and high-risk (HR-Gs) groups were searched in PubMed/MEDLINE/Medigraphic/Scielo databases from January 2008 to December 2019 as per PRISMA guidelines. Weighted mean prevalence (WMP) was estimated; GTs and RFs were registered. RESULTS: In this study, 25,247 new cases were reported. Ten states accumulated 76.32% of HCV incidence that peaked in men at 50-59 years and women at 60-64 years. Thirty-four studies revealed a WMP between 0.774%-2.5% in LR-Gs and 11.8%-39.6% in HR-Gs that included mainly prison inmates, drug users, and dialyzed patients. GT1 and GT2 were predominant; GT3a emerged. Subtypes 1a and 1b circulate differentially, whereas novel GT2 subtypes appeared. Unsafe blood transfusion was infrequent in younger groups, but parenteral/intravenous transmission through drug-related risk behaviors has arisen. CONCLUSIONS: HCV transmission increased notably among LR-Gs and HR-Gs in Mexico. Novel genotypes/subtypes emerged as well as risky behavioral routes of transmission. A national elimination strategy will require pro-active screening in designated risk groups, research in molecular epidemiology, medical training, robust epidemiological databases, and antiviral treatment available to all eligible HCV-infected patients.

Hepatitis B prevalence in Brazilian waste pickers: a systematic review with meta-analysis

ABSTRACT OBJECTIVE: To describe the hepatitis B prevalence in Brazilian waste pickers. METHODS: We performed a literature search in the SciELO, Biblioteca Virtual em Saúde (BVS), PubMed and Web of Science databases using the descriptors: "hepatitis B" AND ("informal recycling" OR "waste picker" OR "recyclable waste collectors" OR "solid waste segregator") AND ("recyclable waste" OR "solid waste") AND Brazil. Epidemiological studies on HBV in Brazilian waste pickers published prior to February 2020 were included and evaluated for quality and bias using a funnel plot. RESULTS: This meta-analysis consisted of five articles. Prevalence of HBV surface antigen seropositivity was 14% (95%CI: 6%-22%) in Brazilian waste pickers. CONCLUSION: HBV prevalence in Brazilian waste pickers remains high. There should be more campaigns showing the importance of vaccination and personal protective equipment use.

Hepatitis A epidemiology in Latin American countries: a 2020 view from a systematic literature review.

INTRODUCTION: The World Health Organization recommends vaccination against hepatitis A virus (HAV) for children aged 1 year and older in areas where endemicity has shifted from high to intermediate. There are no recent comprehensive reviews of the epidemiology of HAV infection in Latin America, but seroprevalence and socioeconomic data suggest that, with improved clean water and sanitation systems, countries are transitioning to intermediate endemicity. AREAS COVERED: We conducted a systematic literature review of the epidemiology of HAV infection in 25 countries in the Latin American region, which included gray literature. We compiled data on HAV incidence and prevalence, including the identification of epidemiological changes observed in countries that established pediatric HAV vaccination programs. EXPERT OPINION: We identified 59 relevant articles, including 34 peer-reviewed seroprevalence studies (12 recent studies from Brazil), three incidence studies, and six vaccine impact studies (three from Argentina). Based on the estimated age at midpoint of population immunity in each country, most have a high-intermediate, intermediate, or low-intermediate level of HAV endemicity, suggesting that national childhood immunization may be an appropriate disease prevention strategy. However, recent data were lacking for most countries. Improved data quality and continued epidemiological surveillance are required for this region.

Testagem universal para hepatite viral C em gestantes no pré-natal / Universal testing for viral hepatitis C in prenatal pregnant women

INTRODUÇÃO: Estima-se que a prevalencia de hepatite C entre gestantes no Brasil varie entre 0,2 e 1,4%, entretanto, a partir de 2014 a taxa de deteccao da doenca entre mulheres em idade fertil dobrou no pais, apos a incorporacao pelo Sistema Unico de Saude de antivirais de acao direta com alta efetividade e seguranca. O risco de transmissao vertical e variavel e depende de fatores como o correto planejamento de procedimentos obstetricos, da viremia materna, de coinfeccao por HIV, entre outros. A hepatite C na gravidez esta relacionada a desfechos em saude desfavoraveis para a gestante e os recem-nascidos e, em longo prazo, a aumento de incidencia de carcinoma hepatocelular, cirrose, necessidade de transplante de figado, utilizacao de servicos de saude e mortalidade. Atualmente a conduta para a deteccao de hepatite C em gestantes depende da prospeccao de fatores de risco pre-existentes, a qual postula-se ser ineficaz na identificação do numero real de casos. O rastreamento e proposto como alternativa a testagem baseada em risco com a finalidade de aumentar a taxa de deteccao de casos, diminuir a transmissao vertical e aumentar a cobertura de tratamentos atendendo a politicas publicas de eliminacao da doenca implementadas pelo Sistema de Saude Publica brasileiro. PERGUNTA: A estrategia de rastreamento para hepatite C em gestantes no primeiro trimestre de gravidez durante o prenatal e eficaz, segura e custo-efetiva quando comparada a testagem baseada em fatores de risco de acordo com a conduta em vigencia preconizada no Protocolo Clinico e Diretrizes Terapeuticas (PCDT) de Hepatite C e Coinfeccoes do Ministerio da Saude? TECNOLOGIA: Testagem universal para hepatite C em gestantes no primeiro trimestre de gravidez durante o pre-natal. EVIDÊNCIAS CLÍNICAS: Identificou-se pela avaliacao de estudos observacionais e transversais descritivos que a estrategia de testagem baseada em risco esta associada a baixos rendimentos diagnostico e sensibilidade, ou a uma baixa deteccao de casos efetivamente diagnosticados de hepatite C em gestantes durante o pre-natal. Em estudo realizado no Canada, pais em que a prevalencia estimada de hepatite C em gestantes e de 0,6%, identificou-se que uma resposta positiva (a questionario estruturado) a pelo menos um dos fatores de risco foi relacionada com uma sensibilidade de 67%, uma especificidade de 28%, um valor preditivo positivo de 0,4% e um valor preditivo negativo de 99% para identificacao de gestantes com HCV. Alem disso, identificou-se que o valor preditivo positivo para essa estrategia e dependente dos fatores de risco avaliados. E possivel que essa variabilidade se traduza em diferentes taxas de deteccao da doenca por meio da estrategia de abordagem por risco, com numero de casos verdadeiramente positivos nao identificaveis variando amplamente entre 2,5% e 27%, mas podendo chegar a 50%. De fato, na maioria dos estudos nao se identificou associação estatisticamente significativa entre a presenca de fatores de risco e ter um diagnostico positivo para hepatite C em gestantes. Em relacao aos criterios de Wilson e Jungner, utilizados na avaliacao de estrategias de rastreamento, identificasse que a maioria deles seriam atendidos, entretanto, ainda nao ha estudos em que se avaliem desfechos em saúde relevantes de curto (de importancia obstetrica e transmissao vertical) e longo prazos (evolucao da doenca e transmissibilidade) associados a implementacao de programa de rastreamento para hepatite C em gestantes. Outro criterio nao atendido e a inexistencia atualmente de tratamento antiviral aprovado para o uso em gestantes. AVALIAÇÃO ECONÔMICA: Foi conduzida uma analise de custo-efetividade na perspectiva do Sistema Unico de Saude para comparar as duas estrategias utilizando-se um modelo estatico de arvore de decisao em combinacao com cadeias de Markov. O rastreamento foi associado a custos incrementais de R$ 288,78 e aumento incremental em anos de vida ajustados pela qualidade (AVAQ-QALY) de 0,18 por gestante rastreada em comparacao com a triagem baseada em risco, com uma razao de custo-efetividade incremental de R$1.617,95 por QALY para rastreamento versus estrategia baseada em risco. Análise de impacto orçamentário: O impacto orcamentario anual associado a implementacao de um programa de rastreamento para hepatite C em gestantes na perspectiva do Sistema Unico de Saude foi de R$ 49 milhoes, com estimativa de gastos de 250 milhoes em cinco anos. Foram considerados os gastos diretos com diagnosticos, exames e procedimentos medicos complementares e tratamento. A variacao de parametros como a taxa de cobertura de gestantes testadas no sistema publico de saude em relacao as testadas no sistema suplementar, a taxa de gestantes testadas no primeiro trimestre de gravidez, o numero de gestantes coinfectadas com HIV e a taxa de oferta de tratamento causam reducoes no impacto orcamentario que variam entre 41 e 55%. RECOMENDAÇÕES INTERNACIONAIS: As Agencias inglesa National Institute for Health and Care Excellence (NICE), a canadense Canadian Agency for Drugs and Technologies in Health (CADTH) e a European Association for the Study of the Liver recomendam a testagem baseada na deteccao de fatores de risco. Nos Estados Unidos o Centers for Disease Control and Prevention (CDC), o U.S. Preventive Services Task Force (USPSTF) e a American Association for the Study of Liver Diseases e a Infectious Diseases Society of America recomendam o rastreamento para hepatite C em gestantes. O American College of Obstetricians and Gynecologists (ACOG) esta atualmente revisando as recomendacoes publicadas em 2017. Na Australia e Nova Zelandia, em documento de 2020, o The Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) recomenda o rastreamento para hepatite C em gestantes. CONSIDERAÇÕES FINAIS: Ha evidencia de moderada qualidade que a estrategia de selecao para testagem de gestantes baseada na identificacao de risco e ineficaz, com baixo valor preditivo positivo e baixa sensibilidade. Apesar de não existem estudos controlados randomizados ou estudos observacionais com braco comparador em que se avaliem as consequencias em saude e os riscos associados a ambas as estrategias, e possivel que o numero de mulheres não detectadas pela estrategia baseada em risco seja significativo com consequencias deleterias para a saude das gestantes e recem-nascidos. Na perspectiva do Sistema Unico de Saude a estrategia de rastreamento se demonstrou mais efetiva que a deteccao baseada em risco com um acrescimo de R$ 288 por gestante testada. Algumas autoridades de saude mundiais vem reformulando as recomendacoes a respeito do diagnostico da hepatite C em gestantes para indicar o rastreamento, principalmente frente ao aumento da taxa de deteccao dos casos mundiais em mulheres, como ocorre no Brasil. A implementacao do programa de rastreamento atende a maioria dos criterios de Wilson e Jungner, exceto a possibilidade de tratamento, que ainda nao e possivel em gestantes. A adocao do rastreamento estaria associada a um incremento de 49 milhoes por ano no orcamento do Ministerio da Saude, principalmente em funcao do alto custo dos tratamentos. RECOMENDAÇÃO INICIAL DA CONITEC: Os membros presentes na 87a reuniao ordinaria da Conitec, que ocorreu no dia 03/06/2020, decidiram, por unanimidade, recomendar a incorporacao da testagem universal para hepatite C em gestantes no pre-natal. CONSULTA PÚBLICA: A consulta publica n° 19/2020, publicada no Diario Oficial da Uniao de 15/06/2020, foi realizada entre os dias 16/06/2020 e 06/07/2020. Foram recebidas 50 contribuicoes, sendo 8 pelo formulario para contribuicoes tecnicocientificas e 42 pelo formulario para contribuicoes sobre experiencia ou opiniao. Entre as 8 contribuicoes recebidas e avaliadas de cunho tecnico-cientifico, 4 foram consideradas para inclusao nesse parecer, todas concordantes com a recomendacao inicial da Conitec. Houve duas contribuicoes de pessoa juridica, da Iniciativa Medicamentos Doenças Negligenciadas (DNDi America Latina) e da Sociedade Brasileira de Infectologia. Os estudos submetidos reforcam a importancia da deteccao acurada de gestantes infectadas pela hepatite C em funcao dos piores desfechos relacionados a gestação nesse contexto e clinico e da possibilidade de encaminhamento das mulheres para acompanhamento para gestação de alto risco, do melhor planejamento de procedimentos obstetricos, de tratamento das mulheres e crianças em momento oportuno apos o parto e do alinhamento com as metas para a eliminacao da doenca no pais, diminuindo a transmissao vertical. Considerou-se a abordagem de testagem por risco como ineficaz. Todas as 42 contribuições recebidas sobre experiencia com a tecnologia ou opiniao sobre a incorporacao traziam contribuicoes em algum dos campos do formulario disponivel para submissao e foram concordantes com a recomendacao inicial da Conitec, incluindo as submetidas pelo Grupo Otimismo de Apoio ao Portador de Hepatite e da Sociedade Brasileira de Hepatologia observando-se grande convergencia entre o conteudo dessas contribuicoes e as de cunho tecnico-cientifico. Apos avaliacao das contribuicoes a Conitec manteve a recomendacao inicial favoravel a incorporacao da testagem universal para hepatite C em gestantes no pre-natal. DECISÃO: Incorporar a testagem universal para hepatite viral C em gestantes no prenatal, conforme protocolo do Ministerio da Saude, no ambito do Sistema Unico de Saude - SUS, conforme Portaria no 32, publicada no Diario Oficial da Uniao no 160, secao 1, pagina 118, em 20 de agosto de 2020.

Hepatitis C Reinfection in People Who Inject Drugs in Resource-Limited Countries: A Systematic Review and Analysis.

Hepatitis C (HCV) is a global pandemic. The World Health Organization has developed a strategic plan for HCV elimination that focuses on low- and middle-income countries (LMICs) and high-risk populations, including people who inject drugs (PWID). While direct-acting antiviral (DAA) therapies are highly effective at eliminating HCV infections and have few side effects, medical professionals and policymakers remain concerned about the risk of reinfection among PWID. This study is a systematic review of research measuring the rate of HCV reinfection among PWID in LMICs and identifies additional areas for further research. A systematic search strategy was used to identify studies documenting HCV reinfection after sustained virologic response in PWID in LMICs. We refined results to include studies where at least 50% of participants had DAA treatment for primary HCV infection. Pooled reinfection rate was calculated across all studies. Seven studies met eligibility criteria. Most studies were conducted in six upper middle-income countries (Mexico, Romania, Russia, Taiwan, Georgi, and Brazil) and one lower middle-income country (Bangladesh) with a total of 7665 participants. No study included information from PWID in low-income countries. Sample sizes ranged from 200 to 3004 individuals, with demographic data missing for most participants. Four studies used deep gene sequencing, and reflex genotyping procedures to differentiate reinfection (infection by a different HCV genotype/subtype) from virologic relapse (infection by the same strain). The follow-up time of people cured from primary chronic HCV infection ranged from 12 weeks to 6.6 years. The pooled reinfection rate of all seven studies was 2.8 (range: 0.02 to 10.5) cases per 100 person-years (PY). In the five studies that differentiated relapse from reinfection, the incidence of reinfection was 1.0 per 100 PY. To date, research on reinfection rates among PWID in LMICs remains limited. Research focused on PWID in low-income countries is particularly needed to inform clinical decision making and evidence-based programs. While rates of reinfection among PWID who complete DAA treatment in upper and lower middle-income countries were similar or lower than rates observed in PWID in high-income countries, the rates were highly variable and factors may influence the accuracy of these measurements. This systematic review identifies several areas for continued research. Policies concerning access to HCV testing and treatment should be comprehensive and not place restrictions on PWID in these settings.

Effectiveness of direct-acting agents for chronic hepatitis C treatment in South America: A systematic review and meta-analysis.

The effectiveness of direct-acting agents (DAAs) for hepatitis C treatment in limited-resource settings remains unclear. We estimated the pooled sustained virological response rates of DAA therapy in South America. We searched online databases for studies that reported 12-week sustained virological response (SVR12) to hepatitis C virus (HCV) treatment in individuals living in South America. Pooled SVR12 in intention-to-treat (ITT) and per-protocol were estimated. Additionally, using all studies with available data, the pooled relative risk (RR) of SVR12 using a random-effects model (DerSimonian-Laird) was estimated to compare effectiveness of DAAs in patients with or without cirrhosis, HIV co-infection or previous HCV therapy. Heterogeneity was assessed using the I2 statistics. We identified 20 studies [14 manuscripts and 6 conference abstracts] comprising 7393 individuals from five countries [Brazil (n = 11), Argentina (n = 4), Chile (n = 1), Colombia (n = 1) and Peru (n = 1)] and two South-American collaborations. The pooled overall SVR12 rates [95% confidence interval (CI)] were 92.6% [90.2-94.7] and 95.5% [94.3-96.6] by ITT (11 studies; n = 4,153; I2  = 84.2%) and per-protocol analysis (15 studies; n = 4,833; I2  = 64.5%), respectively. The RR of SVR12 was similar in patients with or without HIV co-infection [4 studies; RR = 1.03 (0.99-1.07)] and those naive compared with treatment experimented-individuals [9 studies; RR = 1.01 (1.00-1.03)], but significantly higher in patients without cirrhosis compared with those with cirrhosis [11 studies; RR = 1.04 (1.02-1.05), P < .001]. DAAs are highly effective for HCV treatment in South America. The use of DAAs should be considered in limited-resource settings to decrease the burden of liver disease in HCV-infected patients. PROSPERO[CRD 42019134603].