Effectiveness of chronic hepatitis C treatment with direct-acting antivirals in the Public Health System in Brazil

ABSTRACT Introduction Chronic hepatitis C virus infection is one of the major causes of cirrhosis, hepatocellular carcinoma and liver transplantation. Treatment using direct-acting antivirals has revolutionized the treatment of hepatitis C virus, increasing long-term prognosis after cure. The goal of the present study was to evaluate the effectiveness of direct-acting antivirals in a Public Health System in southern Brazil. Methods A retrospective study evaluated all patients with chronic hepatitis C virus infection who underwent treatment at one center of the Public Health Department of the State of Rio Grande do Sul - Brazil, according to the Brazilian Clinical Protocol and Therapeutic Guidelines. The effectiveness was assessed in terms sustained virological response 12 weeks after the end of treatment. Results A total of 1002 patients who were treated for chronic hepatitis C virus infection were evaluated. The mean age was 58.6 years, 557 patients (55.6%) were male and 550 (54.9%) were cirrhotic. Overall sustained virological response was observed in 936 (93.4%) patients. There was a difference in sustained virological response rate varied according to sex, 91.6% in men and 95.7% in women (p= 0.009), length of treatment in genotype 1, 92.7% with 12 weeks and 99.1 with 24 weeks (p= 0.040), and genotype, 94.7% in genotype 1, 91.7% in genotype 2, and 91.4% in genotype 3 (p= 0.047). Conclusion The treatment of chronic hepatitis C virus infection for genotypes 1, 2 or 3 with the therapeutic regimens established by the Brazilian guidelines showed high rates of SVR, even in cirrhotic patients.

Effectiveness of chronic hepatitis C treatment with direct-acting antivirals in the Public Health System in Brazil.

INTRODUCTION: Chronic hepatitis C virus infection is one of the major causes of cirrhosis, hepatocellular carcinoma and liver transplantation. Treatment using direct-acting antivirals has revolutionized the treatment of hepatitis C virus, increasing long-term prognosis after cure. The goal of the present study was to evaluate the effectiveness of direct-acting antivirals in a Public Health System in southern Brazil. METHODS: A retrospective study evaluated all patients with chronic hepatitis C virus infection who underwent treatment at one center of the Public Health Department of the State of Rio Grande do Sul - Brazil, according to the Brazilian Clinical Protocol and Therapeutic Guidelines. The effectiveness was assessed in terms sustained virological response 12 weeks after the end of treatment. RESULTS: A total of 1002 patients who were treated for chronic hepatitis C virus infection were evaluated. The mean age was 58.6 years, 557 patients (55.6%) were male and 550 (54.9%) were cirrhotic. Overall sustained virological response was observed in 936 (93.4%) patients. There was a difference in sustained virological response rate varied according to sex, 91.6% in men and 95.7% in women (p = 0.009), length of treatment in genotype 1, 92.7% with 12 weeks and 99.1 with 24 weeks (p = 0.040), and genotype, 94.7% in genotype 1, 91.7% in genotype 2, and 91.4% in genotype 3 (p = 0.047). CONCLUSION: The treatment of chronic hepatitis C virus infection for genotypes 1, 2 or 3 with the therapeutic regimens established by the Brazilian guidelines showed high rates of SVR, even in cirrhotic patients.

Efficacy of entecavir and tenofovir in chronic hepatitis B under treatment in the public health system in southern Brazil.

There are about 350 million hepatitis B virus (HBV) carriers worldwide and chronic HBV is considered a major public health problem. The objective of the present study was to assess the effectiveness of the nucleos(t)ide analogues tenofovir (TDF) and entecavir (ETV) in the treatment of chronic HBV. A cross-sectional study was carried out from March-December 2013, including all patients with chronic HBV, over 18 years of age, undergoing therapy through the public health system in southern Brazil. Only the data relating to the first treatments performed with TDF or ETV were considered. Retreatment, co-infection, transplanted or immunosuppressed patients were excluded. Six hundred and forty patients were evaluated, of which 336 (52.5%) received TDF and 165 (25.8%) ETV. The other 139 (21.7%) used various combinations of nucleos(t)ide analogues and were excluded. The negativation of viral load was observed in 87.3% and 78.8% and the negativation of hepatitis B e antigen was achieved in 79% and 72% of those treated with ETV or TDF, respectively. Negativation of hepatitis B surface antigen was not observed. There was no occurrence of adverse effects. This is a real-life study demonstrating that long-term treatment with ETV and TDF is both safe and effective.

Triple therapy in chronic hepatitis C: initial series in a public health program in the South of Brazil.

BACKGROUND: Chronic hepatitis C has great impact on world's health. Current therapy for genotype 1 hepatitis C virus includes protease inhibitors boceprevir and telaprevir, associated to standard therapy - peginterferon alfa + ribavirin. There are no published data in Brazil on the results of this new therapy, and it is interesting an evaluation of what was accomplished up to this moment. Objectives To evaluate virologic response to triple therapy, as well as the safety profile and tolerability. METHOD: This study is a clinical series of patients receiving triple therapy for C hepatitis in a single center of a Public Health System of South Brasil. Out of the 121 patients that initiated the triple therapy, the first patients that finished the treatment and evaluated the sustained virological response (24 weeks after the end of treatment) were included. RESULTS: Twenty four genotype 1 chronic hepatitis C monoinfected patients were included. Nineteen (79.2%) patients had been previously treated. Thirteen (54.2%) patients were cirrhotic. Nineteen (79.2%) patients completed the planned therapy. By the end of the treatment, 14 (58.3%) out of 24 patients had undetectable viral load. Sustained virologic response occurred in 12 (50.0%) out of 24 patients, 07 (58.3%) in telaprevir group and 05 (41.7%) in boceprevir group. Out of 24 patients under triple therapy, 58% (n=14) presented anemia. CONCLUSIONS: In conclusion, despite the small number of patients treated with triple therapy evaluated in the current study, it possibly reflects the population under this therapy in real-life.

TRIPLE THERAPY IN CHRONIC HEPATITIS C: initial series in a public health program in the South of Brazil / Terapia tripla em pacientes com hepatite C: experiência inicial em um pólo de aplicação do Sul do Brasil

Background Chronic hepatitis C has great impact on world’s health. Current therapy for genotype 1 hepatitis C virus includes protease inhibitors boceprevir and telaprevir, associated to standard therapy - peginterferon alfa + ribavirin. There are no published data in Brazil on the results of this new therapy, and it is interesting an evaluation of what was accomplished up to this moment. Objectives To evaluate virologic response to triple therapy, as well as the safety profile and tolerability. Method This study is a clinical series of patients receiving triple therapy for C hepatitis in a single center of a Public Health System of South Brasil. Out of the 121 patients that initiated the triple therapy, the first patients that finished the treatment and evaluated the sustained virological response (24 weeks after the end of treatment) were included. Results Twenty four genotype 1 chronic hepatitis C monoinfected patients were included. Nineteen (79.2%) patients had been previously treated. Thirteen (54.2%) patients were cirrhotic. Nineteen (79.2%) patients completed the planned therapy. By the end of the treatment, 14 (58.3%) out of 24 patients had undetectable viral load. Sustained virologic response occurred in 12 (50.0%) out of 24 patients, 07 (58.3%) in telaprevir group and 05 (41.7%) in boceprevir group. Out of 24 patients under triple therapy, 58% (n=14) presented anemia. Conclusions In conclusion, despite the small number of patients treated with triple therapy evaluated in the current study, it possibly reflects the population under this therapy in real-life. .

Contexto A hepatite crônica pelo vírus C tem grande impacto na saúde mundial. A terapia atual do genótipo 1 inclui os inibidores de protease (IP) boceprevir e telaprevir, associados à terapia padrão - alfapeginterferona + ribavirina (PR). No Brasil ainda não há estudos publicados sobre os resultados dessa nova terapia, sendo de interesse uma avaliação do que foi realizado até o momento. Objetivos Avaliar a resposta virológica ao tratamento triplo, bem como o perfil de segurança e tolerabilidade. Métodos O estudo consta de série de casos dos pacientes em uso de terapia tripla para o tratamento da hepatite C em um polo de tratamento da Secretaria Estadual da Saúde do Estado do Rio Grande do Sul, Brasil. Dentre os 121 pacientes que estão em uso de terapia tripla (PR e IP) foram apresentados os dados referentes aos primeiros que finalizaram o tratamento e realizaram avaliação da resposta virológica sustentada na semana 24 pós-tratamento. Resultados Foram incluídos 24 pacientes monoinfectados por hepatite C crônica genótipo 1. Dezenove (79%) pacientes eram previamente experimentados. Treze (54,2%) pacientes apresentavam cirrose. Dezenove (79,2%) pacientes completaram o tratamento planejado. Ao final do tratamento, 14 (58,3%) dos 24 pacientes apresentaram carga viral indetectável. Resposta virológica sustentada ocorreu em 12 (50%) dos 24 pacientes, sendo 07 (58,3%) no grupo telaprevir e 05 (41,7%) no grupo boceprevir. Dos 24 pacientes submetidos à terapia tripla, 58% (n=14) apresentaram anemia. Conclusões Embora o presente estudo tenha avaliado um pequeno número de casos, possivelmente reflete a população submetida à terapia tripla na vida real, despida das restrições dos estudos de registro. .

Re-treatment of previous non-responders and relapsers to interferon plus ribavirin with peginterferon alfa-2a (40KD), ribavirin ± amantadine in patients with chronic hepatitis C: randomized multicentre clinical trial.

INTRODUCTION: A large number of patients with chronic hepatitis C have not been cured with interferon-based therapy. Therefore, we evaluated the efficacy of amantadine combined with the standard of care(pegylated interferon plus ribavirin) in patients who had not responded to or had relapsed after ≥ 24 weeks of treatment with conventional interferon plus ribavirin. MATERIAL AND METHODS: Patients stratified by previous response (i.e., non-response or relapse) were randomized to 48 weeks of open-label treatment with peginterferon alfa-2a (40KD) 180 µg/week plus ribavirin 1,000/1,200 mg/day plus amantadine 200 mg/day (triple therapy), or the standard of care (peginterferon alfa-2a [40KD] plus ribavirin). RESULTS: The primary outcome was sustained virological response (SVR), defined as undetectable hepatitis C virus RNA in serum (< 50 IU/mL) at end of follow-up (week 72). Among patients with a previous non-response, 12/53 (22.6%; 95% confidence interval [CI] 12.3-36.2%) randomized to triple therapy achieved an SVR compared with 16/52 (30.8%; 95% CI 18.7-45.1%) randomized to the standard of care. Among patients with a previous relapse 22/39 (56.4%; 95% CI 39.6-72.2%) randomized to triple therapy achieved an SVR compared with 23/38 (60.5%; 95% CI 43.4-76.0%) randomized to the standard of care. Undetectable HCV RNA (< 50 IU/mL) at week 12 had a high positive predictive value for SVR. A substantial proportion of non-responders and relapsers to conventional interferon plus ribavirin achieve an SVR when re-treated with peginterferon alfa-2a (40KD) plus ribavirin. CONCLUSION: Amantadine does not enhance SVR rates in previously treated patients with chronic hepatitis C and cannot be recommended in this setting.

Câncer gástrico: experiência de um hospital geral / Gastric cancer: experience of a general hospital

Foram revisados 115 prontuários de pacientes internados no Hospital Nossa Senhora da Conceição, em um período de 2 anos, com diagnóstico de câncer gástrico confirmado histolopatologicamente. A incidência foi maior entre homens (2:1), sendo identificada relação entre câncer gástrico e tabagismo, presente em 58,2% dos pacientes. Não foi possível estabelecer relação etiológica com alcoolismo e com história pessoal ou familiar de outras neoplasias. A apresentação endoscópica mais freqüente foi tumor ulcerado (44,7% dos casos), sendo adenocarcinoma o tipo histopatológico mais prevalente. No estadiamento, 67% dos pacientes que realizaram ecografia ou tomografia abdominal apresentaram alterações que sugeriram a presença do tumor ou sua disseminação e 56,5% dos pacientes apresentavam neoplasia gástrica irressecável no momento do diagnóstico. Novos ensaios clínicos randomizados são necessários para o reconhecimento dos fatores de risco para esta neoplasia e possibilitar o estabelecimento de medidas de prevenção e detecção precoce do câncer gástrico em pacientes de alto risco (AU)

The registers of 115 patients with diagnosis of gastric cancer (histopathologically confirmed) from Hospital Nossa Senhora da Conceição in a 2 year period were studied. The incidence was larger among men (2:1), and a relationship between gastric cancer and tobacco smoking, present in 58,2% of the patients, was identified. It was not possible to establish etiological relationship with alcoholism and personal or family history of another neoplasm. The more frequent endoscopic presentation was ulcerated tumor (44,7% of the cases), being adenocarcinoma the more prevalent histopathologic type. Sixty seven percent of the patients that were submitted to abdominal ecography or tomography presented alterations that suggested the presence of the tumor or its dissemination, and 56,5% of the patients presented irresecable gastric cancer in the moment of the diagnosis. New randomized clinical trials are necessary for the recognition of the risk factors for this neoplasm and then establish prevention measures and early detection of gastric cancer in high risk patients (AU)