Effectiveness and safety of first-generation protease inhibitors in real-world patients with hepatitis C virus genotype 1 infection in Brazil: a multicenter study

OBJECTIVE: To evaluate the effectiveness and safety of first-generation protease inhibitors for the treatment of genotype 1 hepatitis C virus-infected patients at Brazilian reference centers. METHODS: This multicenter cross-sectional study included hepatitis C virus genotype 1 monoinfected patients treated with Peg-interferon, ribavirin, and either boceprevir (n=158) or telaprevir (n=557) between July 2013 and April 2014 at 15 reference centers in Brazil. Demographic, clinical, virological, and adverse events data were collected during treatment and follow-up. RESULTS: Of the 715 patients, 59% had cirrhosis and 67.1% were treatment-experienced. Based on intention-to-treat analysis, the overall sustained viral response was 56.6%, with similar effectiveness in both groups (51.9% for boceprevir and 58% for telaprevir, p=0.190). Serious adverse events occurred in 44.2% of patients, and six deaths (0.8%) were recorded. Cirrhotic patients had lower sustained viral response rates than non-cirrhotic patients (46.9% vs. 70.6%, p 465 years, diagnosis of cirrhosis, and abnormal hemoglobin levels/platelet counts prior to treatment were associated with serious adverse events. CONCLUSION: Although serious adverse events rates were higher in this infected population, sustained viral response rates were similar to those reported for other patient cohorts.Univ Sao Paulo, Fac Med, Dept Molestias Infecciosas & Parasitarias, Sao Paulo, SP, BrazilUniv Fed Rio de Janeiro, Rio De Janeiro, RJ, BrazilCtr Referencia & Treinamento DST Aids, Sao Paulo, SP, BrazilCDH, Rio De Janeiro, RJ, BrazilHosp Fed Servidores Estado Rio de Janeiro HFSE, Setor Gastrohepatol, Rio De Janeiro, RJ, BrazilUniv Sao Paulo, Fac Med, Dept Gastroenterol & Hepatol, Sao Paulo, SP, BrazilUniv Fed Sao Paulo UNIFESP, Disciplina Gastroenterol, EPM, Sao Paulo, SP, BrazilUniv Fed Sao Paulo UNIFESP, EPM, Disciplina Infectol, Sao Paulo, SP, BrazilUniv Sao Paulo, FMRP, Dept Clin Med, Div Gastroenterol, Sao Paulo, SP, Brazil| Univ Fed do Maranhao UFMA, HUPD, Ctr Pesquisa Clin, Sao Luis, MA, BrazilUniv Fed Estado Rio de Janeiro UNIRIO, Disciplina Clin Med & Gastroenterol, Rio De Janeiro, RJ, BrazilUniv Fed Rio do Grande Sul UFRGS, Dept Med Interna, Porto Alegre, RS, BrazilUniv Fed Espirito Santo, Ambulatorio HIV AIDS Hepatites Virais, Vitoria, ES, BrazilSMS, Ctr Orientacao & Aconselhamento, Foz Do Iguacu, PR, BrazilUniv Estado Rio de Janeiro UERJ, Serv Gastroenterol, Rio De Janeiro, RJ, BrazilIMT, Lab Virol LIM 52, Sao Paulo, SP, BrazilUniv Fed Sao Paulo UNIFESP, Disciplina Gastroenterol, EPM, Sao Paulo, SP, BrazilUniv Fed Sao Paulo UNIFESP, EPM, Disciplina Infectol, Sao Paulo, SP, BrazilWeb of Scienc

Updated cardiovascular prevention guideline of the Brazilian Society of Cardiology: 2019

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Predictors of response to chronic hepatitis C treatment

INowadays the standard of care for hepatitis C therapy is based on Pegylated interferon alpha and ribavirin (Peg IFN/RBV). This combination has led to a sustained virological response rate (SVR) of 50 to 80% depending on genotype. This is still low, considering the side effects, overall costs and duration of therapy. So far, strategies to foresee SVR have been described such as genotype, fibrosis stage, viral load and gamma-glutamyltransferase. In addition, new data has recently been provided on predictive factors of SVR like genetic polymorphism related to race, insulin resistance and viral kinetics. This review aims to discuss these predictive factors of therapy that might help the decision about starting or discontinuing therapy in chronic HCV infected patients

Prevalência da infecção pelo vírus B na comunidade hospitalar

Estudou-se a prevalência de marcadores para a hepatite B (HBsAg, AntiHBc e AntiHBs) em profissionais de saúde, a fim de identificar grupos de maior risco onde estaria indicada a vacinação pré-exposição. Comparando-os com os funcionários administrativos do mesmo hospital, observamos índices significativamente superiores em grupos como cirurgiões (40,0%) e profissionais de hemodiálise (36,4%), que apresentaram taxas deferimentos no trabalho, de, respectivamente, 93,3% e 77,3%. Outros grupos mostraram grande aumento da prevalência em função do maior tempo de atuação profissional, comprovando seu risco. Outras formas de transmissão, como transfusão e contato íntimo com portadores de hapatite, não tiveram significância. Os autores concluíram que a vacinação está indicada em cirurgiões e profissionais de hemodiálise, bem como dentistas e técnicos de laboratório.<br>The authors studied the prevalence of HBV markers among health care personnel of the Univer- sity Hospital of the Federal University of Rio de Janeiro. The aim ofstudy was to identify the high risk groups, in order to counsel vaccínation of those groups at risk as a routine. As a control group, a group of office workers of the hospital were chosen. A significant difference of incidence of HBV markers, mainly in surgeons (40%) and hemodialysis unit personnel (36.4%) when compared to the control group, was observed (p < 0.05). The incidence increased with age and the time spent in the profession. The authors concluded that vaccination is indicated in surgeons hemodialy sis personnel, dentists and laboratory personnel

No correspondence between resistance mutations in the HCV-NS3 protease at baseline and early telaprevir-based triple therapy

Direct-acting antiviral (DAA)-based therapy is the new standard treatment for chronic hepatitis C virus (HCV) infection. However, protease inhibitor (PI)-resistant viral variants have been often described. This study aimed to examine HCV-NS3 protease variants at baseline and at 4 weeks under triple therapy. To this end, we analyzed the presence of variants in HCV-NS3 protease region from peripheral blood samples of 16 patients infected with HCV-1 at baseline and at 4 weeks of combined therapy with telaprevir, pegylated interferon, and ribavirin, using next-generation sequencing. Several variants with synonymous and non-synonymous amino acid substitutions were detected at both time points. Variants detected at low frequency corresponded to 74% (HCV-1a) and 35% (HCV-1b) of non-synonymous substitutions. We found nine PI-resistance-associated variants (V36A, T54S, V55I, Q80K, Q80R, V107I, I132V, D168E, M175L) in HCV-NS3 of 10 patients. There was no correspondence of resistance-associated variant profile between baseline and at 4 weeks. Moreover, these resistance variants at baseline and short-term treatment are not good predictors of outcome under triple therapy. Our study also shows a large number of others minor and major non-synonymous variants in HCV-NS3 early in telaprevir-based therapy that can be important for further drug resistance association studies with newly developed PI agents

Effectiveness and safety of first-generation protease inhibitors in real-world patients with hepatitis C virus genotype 1 infection in Brazil : a multicenter study

OBJECTIVE: To evaluate the effectiveness and safety of first-generation protease inhibitors for the treatment of genotype 1 hepatitis C virus-infected patients at Brazilian reference centers. METHODS: This multicenter cross-sectional study included hepatitis C virus genotype 1 monoinfected patients treated with Peg-interferon, ribavirin, and either boceprevir (n=158) or telaprevir (n=557) between July 2013 and April 2014 at 15 reference centers in Brazil. Demographic, clinical, virological, and adverse events data were collected during treatment and follow-up. RESULTS: Of the 715 patients, 59% had cirrhosis and 67.1% were treatment-experienced. Based on intention-totreat analysis, the overall sustained viral response was 56.6%, with similar effectiveness in both groups (51.9% for boceprevir and 58% for telaprevir, p=0.190). Serious adverse events occurred in 44.2% of patients, and six deaths (0.8%) were recorded. Cirrhotic patients had lower sustained viral response rates than non-cirrhotic patients (46.9% vs. 70.6%, po0.001) and a higher incidence of serious adverse events (50.7% vs. 34.8%, po0.001). Multivariate analysis revealed that sustained viral response was associated with the absence of cirrhosis, viral recurrence after previous treatment, pretreatment platelet count greater than 100,000/mm3, and achievement of a rapid viral response. Female gender, age465 years, diagnosis of cirrhosis, and abnormal hemoglobin levels/platelet counts prior to treatment were associated with serious adverse events. CONCLUSION: Although serious adverse events rates were higher in this infected population, sustained viral response rates were similar to those reported for other patient cohorts

Direct antiviral therapy for treatment of hepatitis C: A real-world study from Brazil

Introduction and objectives: Direct antiviral agents (DAAs) including sofosbuvir (SOF), daclatasvir (DCV), simeprevir (SIM) and ombitasvir, paritaprevir and dasabuvir were introduced 2015 in Brazil for treatment of hepatitis C virus (HCV) infection. The aims of this study were to assess effectiveness and safety of HCV treatment with DAA in real-life world in a highly admixed population from Brazil. Materials and methods: All Brazilian reference centers for HCV treatment were invited to take part in a web-based registry, prospectively conducted by the Brazilian Society of Hepatology, to assess outcomes of HCV treatment in Brazil with DAAs. Data to be collected included demographics, disease severity and comorbidities, genotype (GT), viral load, DAA regimens, treatment side effects and sustained virological response (SVR). Results: 3939 patients (60% males, mean age 58 ± 10 years) throughout the country were evaluated. Most had advanced fibrosis or cirrhosis, GT1 and were treated with SOF/DCV or SOF/SIM. Overall SVR rates were higher than 95%. Subjects with decompensated cirrhosis, GT2 and GT3 have lower SVR rates of 85%, 90% and 91%, respectively. Cirrhosis and decompensated cirrhosis in GT1 and male sex and decompensated cirrhosis in GT3 were significantly associated with no SVR. Adverse events (AD) and serious AD occurred in 18% and 5% of those subjects, respectively, but less than 1% of patients required treatment discontinuation. Conclusion: SOF-based DAA regimens are effective and safe in the heterogeneous highly admixed Brazilian population and could remain an option for HCV treatment at least in low-income countries