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<0.001) and a higher incidence of serious adverse events (50.7% vs. 34.8%, p<0.001). 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, age>65 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.

RESUMO Objetivo: Caracterizar uma coorte de pacientes com hepatite B crônica, segundo parâmetros iniciais e evolutivos. Métodos: Análise retrospectiva e descritiva dos dados clínicos e laboratoriais de portadores crônicos adultos do HBsAg, sem HIV, virgens de tratamento, com ao menos duas consultas ambulatoriais entre fevereiro de 2006 a novembro de 2012. Empregaram-se os testes exato de Fisher, χ², Wilcoxon, Spearman, Kappa e comparações múltiplas, o nível de significância estatística adotado foi de 5% e intervalo de confiança de 95%. Resultados: Foram incluídos 175 pacientes com média de idade de 42,95±12,53 anos, 93 (53,1%) do sexo masculino, 152 (86,9%) não reagentes para o antígeno e (HBeAg), 3 (1,7%) coinfectados com hepatite C, 15 (8,6%) cirróticos e 2 (1,1%) com carcinoma hepatocelular. Predominou o genótipo A. Constataram-se hepatite ativa em 66 pacientes (37,7%), imunotolerância em 6 (3,4%), estado de portador inativo em 38 (21,7%), exacerbações e/ou escapes virais em 16 (9,1%). Em 32 (18,3%), havia DNA viral persistentemente elevado e alanina aminotransferase normal; em 17 (9,7%), carga viral constantemente baixa e alanina aminotransferase alterada. Se fossem considerados apenas transaminases e DNA viral iniciais, 15 casos de hepatite ativa não teriam sido evidenciados. Fibrose avançada foi mais prevalente em HBeAg reagentes e associou-se direta e significativamente ao DNA do vírus da hepatite, idade e transaminases. Conclusão: Grande parte dos pacientes apresentou hepatite ativa. Porém, aproximadamente um quarto (todos pertencentes ao grupo HBeAg não reagente) foram identificados somente em função da análise conjunta das mensurações sequenciais de DNA do vírus da hepatite e transaminases, por vezes aliada a dados histológicos, após seguimento.

ABSTRACT Objective: To characterize a chronic hepatitis B cohort based on initial and follow-up clinical evaluations. Methods: A retrospective and descriptive analysis of clinical and laboratory data from chronic HBsAg adult carriers, without HIV, unexposed to treatment, with at least two outpatient visits, between February 2006 and November 2012. Fisher´s exact test, χ², Wilcoxon, Spearman, multiple comparisons and Kappa tests were applied, the level of significance adopted was 5%, with a 95% confidence interval. Results: 175 patients with mean age of 42.95±12.53 years were included: 93 (53.1%) were men, 152 (86.9%) were negative for hepatitis B e-antigen (HBeAg), 3 (1.7%) had hepatitis C coinfection, 15 (8.6%) had cirrhosis, and 2 (1.1%) had hepatocellular carcinoma. Genotype A predominated. Sixty-six patients (37.7%) had active hepatitis, 6 (3.4%) presented immune tolerance, and 38 (21.7%) were inactive carriers. Exacerbations and/or viral breakthrough were detected in 16 patients (9.1%). In 32 patients (18.3%), hepatitis B virus DNA remained persistently elevated and alanine aminotransferase levels were normal, whereas in 17 (9.7%), there was low hepatitis B virus DNA and alterated alanine aminotransferase. If only initial alanine aminotransferase and hepatitis B virus DNA values were considered, 15 cases of active hepatitis would not have been detected. Advanced fibrosis was more common in HBeAg-positive patients, and it was significantly associated with transaminases, hepatitis B virus DNA, and age. Conclusion: Many patients had active hepatitis, but almost 25%, who were HBeAg non-reactive, were only identified because of combined analyses of the hepatitis B virus DNA and transaminases levels, sometimes associated with histological data, after clinical follow-up.

INTRODUÇÃO: Atualmente, a abordagem nutricional desempenha papel essencial no tratamento de pessoas que vivem com HIV/aids, particularmente no caso de alterações metabólicas pelo uso da terapia antirretroviral (TARV) que podem estar associadas ao maior risco de doenças cardiovasculares (DCV). OBJETIVO: Caracterizar o estado nutricional, clínico e a qualidade da dieta de pessoas que vivem com HIV/aids. METODOLOGIA: Trata-se de um estudo transversal envolvendo pessoas que vivem com HIV/aids em atendimento na rede de serviços especializados no município de São Paulo. Os usuários desta rede, em uso ou não de TARV, foram recrutados no período de dezembro de 2004 a maio de 2006, durante consultas de rotina. Foram coletados dados sociodemográficos, clínicos, bioquímicos, antropométricos e dietéticos. A qualidade da dieta foi avaliada segundo escores de padrão de consumo predominantemente "não protetor" e "protetor" para DCV. RESULTADOS: A amostra foi constituída por 238 pacientes em TARV e 76 sem TARV. A média dos níveis de colesterol total, triglicérides e glicemia foram maiores no grupo TARV (p < 0,001). A maior parte dos participantes do estudo, com e sem TARV, apresentava-se eutrófica, com média de índice de massa corporal 24,4 (± 4,3) e 24,3 (± 3,5) kg/m², respectivamente. A relação cintura-quadril foi maior entre homens em TARV que entre aqueles sem TARV (0,90 ± 0,06 versus 0,87 ± 0,05) (p < 0,001). O grupo em TARV apresentou média de escores indicativa de maior consumo de alimentos "não protetores" para DCV (p = 0,001). CONCLUSÃO: Foram evidenciadas condições nutricionais e metabólicas indesejáveis entre aqueles em TARV, predisponentes ao risco de DCV. É apontada a necessidade de direcionamento das intervenções em saúde a pessoas que vivem com HIV/aids, para o controle dos fatores associados a essas doenças antes do desfecho final.

INTRODUCTION: Nutrition currently plays a key role in the treatment of people living with HIV/AIDS (PLHA), especially in the case of metabolic alterations due to highly active antiretroviral therapy (HAART), which could be related to cardiovascular diseases (CD). OBJECTIVE: to describe the nutritional and clinical status, and the quality of diet of PLHA. METHODS: It is a cross-sectional study involving a network of ambulatory care facilities for PLHA in the city of São Paulo, Brazil. Patients, in use of HAART or not, were selected from December 2004 to may 2006, through routine clinic visits. We collected: socio-demographic, clinical, biochemical, anthropometric measures and dietary data. Diet quality was evaluated according to a "protecting" or "non-protecting" pattern of consumption scores for CD. RESULTS: The sample had 238 patients on HAART and 76 without treatment. Mean serum levels of total cholesterol, triglycerides and glucose were higher in the HAART group (p < 0.001). The majority of patients of both the treated and untreated group were eutrophic with a mean body mass index (BMI) of 24.4 (± 4.3) kg/m² and 24.3 (± 3.5), respectively. The waist-hip ratio was higher among men on HAART (0.90 ± 0.06 versus 0.87±0.05) (p < 0.001). The HAART group showed a mean food pattern score indicating a higher consumption of "non-protecting" foods for CD (p = 0.001). CONCLUSION: The results showed undesired nutritional and metabolic conditions among patients on HAART associated with CD. It is necessary to manage health intervention programs for PLHA in order to control cardiovascular risk factors before final outcomes.

INTRODUÇÃO: Atualmente, a abordagem nutricional desempenha papel essencial no tratamento de pessoas que vivem com HIV/aids, particularmente no caso de alterações metabólicas pelo uso da terapia antirretroviral (TARV) que podem estar associadas ao maior risco de doenças cardiovasculares (DCV). OBJETIVO: Caracterizar o estado nutricional, clínico e a qualidade da dieta de pessoas que vivem com HIV/aids. METODOLOGIA: Trata-se de um estudo transversal envolvendo pessoas que vivem com HIV/aids em atendimento na rede de serviços especializados no município de São Paulo. Os usuários desta rede, em uso ou não de TARV, foram recrutados no período de dezembro de 2004 a maio de 2006, durante consultas de rotina. Foram coletados dados sociodemográficos, clínicos, bioquímicos, antropométricos e dietéticos. A qualidade da dieta foi avaliada segundo escores de padrão de consumo predominantemente "não protetor" e "protetor" para DCV. RESULTADOS: A amostra foi constituída por 238 pacientes em TARV e 76 sem TARV. A média dos níveis de colesterol total, triglicérides e glicemia foram maiores no grupo TARV (p < 0,001). A maior parte dos participantes do estudo, com e sem TARV, apresentava-se eutrófica, com média de índice de massa corporal 24,4 (± 4,3) e 24,3 (± 3,5) kg/m², respectivamente. A relação cintura-quadril foi maior entre homens em TARV que entre aqueles sem TARV (0,90 ± 0,06 versus 0,87 ± 0,05) (p < 0,001). O grupo em TARV apresentou média de escores indicativa de maior consumo de alimentos "não protetores" para DCV (p = 0,001). CONCLUSÃO: Foram evidenciadas condições nutricionais e metabólicas indesejáveis entre aqueles em TARV, predisponentes ao risco de DCV. É apontada a necessidade de direcionamento das intervenções em saúde a pessoas que vivem com HIV/aids, para o controle dos fatores associados a essas doenças antes do desfecho final.

INTRODUCTION: Nutrition currently plays a key role in the treatment of people living with HIV/AIDS (PLHA), especially in the case of metabolic alterations due to highly active antiretroviral therapy (HAART), which could be related to cardiovascular diseases (CD). OBJECTIVE: to describe the nutritional and clinical status, and the quality of diet of PLHA. METHODS: It is a cross-sectional study involving a network of ambulatory care facilities for PLHA in the city of São Paulo, Brazil. Patients, in use of HAART or not, were selected from December 2004 to may 2006, through routine clinic visits. We collected: socio-demographic, clinical, biochemical, anthropometric measures and dietary data. Diet quality was evaluated according to a "protecting" or "non-protecting" pattern of consumption scores for CD. RESULTS: The sample had 238 patients on HAART and 76 without treatment. Mean serum levels of total cholesterol, triglycerides and glucose were higher in the HAART group (p < 0.001). The majority of patients of both the treated and untreated group were eutrophic with a mean body mass index (BMI) of 24.4 (± 4.3) kg/m² and 24.3 (± 3.5), respectively. The waist-hip ratio was higher among men on HAART (0.90 ± 0.06 versus 0.87±0.05) (p < 0.001). The HAART group showed a mean food pattern score indicating a higher consumption of "non-protecting" foods for CD (p = 0.001). CONCLUSION: The results showed undesired nutritional and metabolic conditions among patients on HAART associated with CD. It is necessary to manage health intervention programs for PLHA in order to control cardiovascular risk factors before final outcomes.

The clinical and epidemiological importance of chronic B hepatitis is currently unquestionable as a cause of end-stage liver disease and hepatocellular carcinoma. Recently, predictors of treatment response of this disease have been studied, both before and during the course of medication. Therapy stopping rules have been proposed, which may be useful in patients presenting poor treatment tolerance. This review discusses the treatment response predictors usefulness, with emphasis on ALT, quantitative HBsAg and HBeAg, quantitative HBV-DNA and HBV genotype