nsaio clínico randomizado para avaliação da eficácia do tratamento com sofosbuvir mais daclatasvir ou simeprevir no tratamento de pacientes com hepatite C crônica genótipo 1 não cirróticos

• Ano de defesa: 2017
• Autor(a) principal: Pott Junior, Henrique [UNIFESP]
• Tipo de documento: Tese
• Tipo de acesso: Acesso aberto
• dARK ID: ark:/48912/001300001nksp
• Idioma: por
• Instituição de defesa: Universidade Federal de São Paulo (UNIFESP)
• Palavras-chave em Português: Hepatitis C, chronic; Randomized controlled trial; Sofosbuvir; Daclatasvir; Simeprevir; Hepatite C crônica; Ensaio clínico randomizado
• Link de acesso: https://sucupira.capes.gov.br/sucupira/public/consultas/coleta/trabalhoConclusao/viewTrabalhoConclusao.jsf?popup=true&id_trabalho=5227897; http://repositorio.unifesp.br/handle/11600/50729

ABSTRACT Introduction: This study investigated the safety and efficacy of simeprevir plus sofosbuvir (SOF+SIM) or daclatasvir plus sofosbuvir (SOF+DCV) regimen in a randomized, open-label, non-inferiority trial in patients infected with HCV genotype 1 infection who had previously not responded to pegylated interferon and ribavirin or were treatment naive. Methods: Patients were assigned randomly (1:1) to receive simeprevir (150 mg, once daily) and sofosbuvir (400 mg, once daily) or daclatasvir (60 mg, once daily) and sofosbuvir (400 mg, once daily) for 12 weeks. Analysis included all participants who received at least one dose of study drugs. The primary endpoint was sustained virological response 4 weeks after ending treatment (SVR4; HCV RNA measured using COBAS TaqMan RT-PCR [lower limit of detection and quantification of 12 UI/mL]). This study is registered at the ClinicalTrials.gov, number NCT02624063. Results: 127 patients were enrolled and randomized, and 125 started treatment (n=60 in SOF+SIM and n=65 in SOF+DCV). SVR4 was achieved in 121 (96.85%) patients (n=56 [93.33%, 95% CI 83.8-98,2] in SOF+SIM and n=65 [100%, 94.5-100] in SOF+DCV; absolute difference 6.66%, 95% CI -0.159 to 0.002). The most common adverse events in the pooled groups were fatigue (n=32 [25.6%]), headache (n=27 [21.6%]), and mood swings (n=24 [19.2%]). No patients were discontinued from the study. Conclusion: Although there was no statistically significant difference in SVR4 rates between groups, non-inferiority of the SOF+SIM in relation to SOF+DCV could not be established as it violated the non-inferiority margin. Therefore, the results of SOF+SIM in relation to SOF+DCV differ enough to be clinically relevant.