-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. Conclusion -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.
In 2012, the first-generation protease inhibitors telaprevir (TVR) and boceprevir (BOC) were introduced in the Brazilian health system for treatment of chronic hepatitis C, after their approval by the National Committee for Health Technology Incorporation (CONITEC). However, these medicines were discontinued in 2015. The short period of use in therapy and their high cost require a discussion about the consequences for patients and for the health system of the early incorporation of new therapies. The article presents a qualitative analysis of the incorporation process of both medications in Brazil and the results of a multicenter study that included patients treated with BOC or TVR between January 2011 and December 2015 in five Brazilian cities. The study included 855 patients (BOC: n=247) and (TVR: n=608). The document analysis showed that CONITEC’s decision to incorporate BOC and TVR was based on results of phase III clinical trials that compared sustained virologic response (SVR) rates of patients treated with BOC and TVR with rates of those that received placebo. However, these studies included a low percentage of cirrhotic patients. The SVR rates observed in this multicenter study were worse than clinical trials pointed out (BOC: 45.6%; TVR: 51.8%), but similar to those achieved with previously adopted therapies. The discontinuation rate due to adverse events was (BOC: 15.4%; TVR: 12.7%). Based on these unsatisfactory results, the study brings a discussion that goes beyond the therapy outcomes, exploring the incorporation of these high-cost medicines and the related decision-making process, contributing to future decisions in medicine policies and in the treatment of chronic hepatitis C.
Although the protease inhibitors have revolutionized the therapy of chronic hepatitis C (CHC), the concomitant use of pegylated-interferon (PEG-IFN) and ribavirin (RBV) is associated to a high rate of adverse effects. In this study, we evaluated the consequences of PEG-IFN and RBV and their relationship with mortality in patients with cirrhosis.METHODS: Medical records of CHC who underwent treatment with PEG-IFN and RBV in a public hospital in Brazil were evaluated. All the patients with cirrhosis were selected, and their clinical and laboratory characteristics, response to treatment, side effects and mortality were evaluated. RESULTS: From the 1,059 patients with CHC, 257 cirrhotic patients were evaluated. Of these, 45 (17.5%) achieved sustained viral response (SVR). Early discontinuation of therapy occurred in 105 (40.8%) patients, of which 39 (15.2%) were due to serious adverse effects. The mortality rate among the 257 cirrhotic patients was 4.3%, occurring in 06/242 (2.4%) of the Child-A, and in 05/15 (33.3%) of the Child-B patients. In conclusion, the treatment of patients with cirrhosis due to HCV with PEG-IFN and RBV shows a low SVR rate and a high mortality, especially in patients with liver dysfunction.
Introduction: Many patients coinfected with the human immunodeficiency virus (HIV) and hepatitis C virus (HCV) are using highly active antiretroviral therapy (HAART) and HCV therapy with peginterferon (PEG-IFN) and ribavirina (RBV) because the use of direct-acting antivirals is not a reality in some countries. To know the impact of such medications in the sustained virological response (SVR) during HCV treatment is of great importance. Methodology: This was a retrospective cohort study of 215 coinfected HIV/HCV patients. The patients were treated with PEG-IFN and RBV between 2007 and 2013 and analyzed by intention to treat. Treatment-experienced patients to HCV and carriers of hepatitis B were excluded. Demographic data (gender, age), mode of infection, HCV genotype, HCV viral load, hepatic fibrosis, HIV status, and type of PEG were evaluated. One hundred eighty-eight (87.4%) patients were using HAART. Results: SVR was achieved in 55 (29.3%) patients using HAART and in 9 (33.3%) patients not using HAART (p = 0.86). There was no difference in SVR between different HAART medications and regimens using two reverse transcriptase inhibitor nucleosides (NRTIs) or the use of protease inhibitors and non-NRTIs (27.1% versus 31.5%; p = 0.61). The predictive factors for obtaining SVR were low HCV viral load, non-1 genotype, and the use of peginterferon-α2a. Conclusions: The use of HAART does not influence the SVR of HCV under PEG-IFN and RBV therapy in HIV/HCV coinfected patients.
Resumo: Objetivo: Realizar uma avaliação de custo-minimização, comparando os medicamentos gosserrelina e leuprorrelina no tratamento do câncer de próstata avançado em um hospital público de Porto Alegre, RS. Métodos: Estudo retrospectivo com dados secundários de pacientes atendidos de janeiro a dezembro de 2016 em um hospital geral, de grande porte. A análise econômica dos tratamentos comparou os medicamentos gosserrelina 10,8 mg e leuprorrelina 22,5 mg em regime de aplicação trimestral, na perspectiva do sistema público de saúde. Resultados: Foram analisados os dados de 458 pacientes, 37,8% residentes em Porto Alegre, RS e 62,2 %, em outros municípios do estado. A média de idade foi de 73 ano, e a média de idade do diagnóstico do câncer de próstata foi de 68 anos. Em relação ao tratamento, 85,4% fizeram uso de gosserrelina, com um custo total de R$ 4.725,84 por ano, por paciente e 14,6% utilizaram leuprorrelina, a um custo anual por paciente de R$ 2.968,20. Conclusões: A leuprorrelina foi o medicamento menos oneroso nesta avaliação. Recomendamos que as instituições realizem análises econômicas com objetivo de avaliar a viabilidade dos tratamentos padronizados, considerando custo, evidências científicas, logística do tratamento e preferências do paciente.Palavras chaves: Neoplasias da próstata; Gosserrelina; Leuprorrelina; custos e análise de custo.
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