Hepatitis C disease burden and strategies for elimination by 2030 in Brazil. A mathematical modeling approach

ABSTRACT Introduction and aim: Hepatitis C is a key challenge to public health in Brazil. The objective of this paper was to describe the Brazilian strategy for hepatitis C to meet the 2030 elimination goal proposed by World Health Organization (WHO). Methods: A mathematical modeling approach was used to estimate the current HCV-infected Brazilian population, and to evaluate the relative costs of two different scenarios to address HCV disease burden in Brazil: (1) if no further changes are made to the HCV treatment program in Brazil; (2) where the WHO targets for 2030 elimination are met through diagnosis and treatment efforts peaking before 2024. Results: An anti-HCV prevalence of 0.53% was calculated for the total population. It was estimated that the number of HCV-RNA+ individuals in Brazil in 2017 was 632,000 (0.31% of the population). Scale-up of treatment and diagnosis over time will be necessary in order to achieve WHO targets beginning in 2018. Direct costs (diagnostic, treatment and healthcare costs) are projected to increase significantly during the scale-up of treatment and diagnosis in the initial years of the intervention scenario, but then fall below the base case on an annual basis by 2025-2036, once HCV is eliminated, due to health sectors savings from the prevention of HCV liver-related morbidity and mortality. Conclusion: Achieving the WHO targets is technically feasible in Brazil with a scale-up of treatment and diagnosis over time, beginning in 2018. However, elimination of hepatitis C requires policy changes to substantially scale-up prevention, screening and treatment of HCV, together with public health advocacy to raise awareness among affected populations and healthcare providers.

Risk factors for hepatitis C disease in Tando Allahyar, Pakistan: a case-control study.

Objective: Present study was undertaken to explore the epidemiological and dietary risk factors for hepatitis C disease in Tando Allahyar during June to December 2007. Materials and methods: 140 Hepatitis C patients and 149 controls (age, sex and locality matched with no personal or family history of hepatitis C) were randomly selected from the Tando Allahyar population during June 2007 to December 2007. A standard questionnaire specially developed for that purpose, was distributed among patients and controls. Accurate rapid card test was performed to confirm Hepatitis C virus (HCV) positive or negative patients and controls. O.R with 95% confidence interval was computed and p values were calculated by chi square test. Results: Over all findings showed that among 140 HCV patients 64% were females and 36% males (mean age range was 20-48 years). Our results showed strong positive association of sedentary life style (OR=4, 95% CI, 1.48-10.6, p=0.005), marital status, +ve family history, B+ve blood group, piercing, syringe use (70%), multiple pregnancies (OR=4.72, 95% CI, 1.47-15.15, p=0.008), blood transfusion (OR=4.4, 95% CI, 1.2-14.95, p=0.017), take out food debris by office pins (NS), shave at barber’s shop (NS), dental procedures (NS), medicines used in past (OR=3.08, 95% CI, 1.2-7.71, P=0.016), G.I.T diseases (OR =8.66, 95% CI, 1.28-55.58, p=0.023), stones of kidney or gallbladder, jaundice, Tuberculosis and psychological problems (OR =2.5, 95% CI, 1.04-6.13, P=0.04) with hepatitis C disease. We did not find any association of surgery, BMI, ENT, diseases, meat consumption and smoking with the disease. Vegetables OR =0.842, 95% CI, 0.361-1.964, P=0.694), pulses, tomatoes (OR =0.31, 95% CI, 0.041-2.53, P=0.31), and tea (OR =0.598, 95% CI, 0.251-1.431, P=0.25) were found to be the protective factors for Hepatitis C disease. Conclusion: Sedentary life style, multiple pregnancies, blood transfusion, medicines used in past, G.I.T diseases, and psychological problems are significantly positively associated with Hepatitis C disease.

Beyond the informed consent procedure: continuing consent in human research

An ethnographic field study about informed consent in hepatitis C clinical trials provides insight into how changes in protocol requirements and patient health status triggered the actions and decisions of researchers and human subjects during the conduct of these trials. U.S. federal guidelines recommend that informed consent should be conceptualized as more than a one-time event. Rather, a process of continuing consent should be the standard but little is understood about how exactly this process should unfold. We used a proposed typology of continuing consent to frame our analysis and were able to document that only some of the proposed types took place at the site of our study. The most frequent practice involved the researchers' re-consent of their subjects for major protocol revisions. Only one subject dissented and chose to withdraw even though he was technically eligible to continue in the study. Two other types of continuing consent were not observed. We discovered an additional type of continuing consent not described in the typology whereby subjects gave implied consent through their cooperation and adherence to the on-going requirements of the protocols. Implications for the informed consent process and the need for further research are presented.

Um estudo etnográfico sobre o consentimento informado em pesquisas clínicas sobre Hepatite C permite compreender como as mudanças no protocolo e estado da saúde do paciente influenciam as ações e decisões dos pesquisadores e sujeitos durante estas pesquisas. As diretrizes federais americanas recomendam que o consentimento informado deva ser entendido como algo mais do que um evento único. Mais precisamente, deve-se seguir um processo de consentimento contínuo como padrão, mas pouco se sabe sobre como exatamente esse processo deve ser desenvolvido. Usamos uma tipologia de consentimento contínuo para nortear a análise e documentamos que só alguns dos tipos propostos ocorreram em nosso campo de estudo. A prática mais freqüente tratava do re-consentimento dos sujeitos para as principais revisões do protocolo. Só um sujeito não consentiu e escolheu sair da pesquisa, apesar de ser tecnicamente elegível para o estudo. Dois outros tipos de consentimento contínuo não foram observados. Descobrimos um tipo adicional de consentimento contínuo, não descrito na tipologia, no qual os sujeitos deram um consentimento implícito por meio de sua cooperação e adesão aos protocolos em andamento. São apresentadas algumas implicações para o processo de consentimento informado e a necessidade de outras pesquisas.