Grazoprevir/elbasvir in peginterferon alfa plus ribavirin experienced patients with chronic genotype 1 HCV/HIV co-infection: a non-randomized, open-label clinical trial

Abstract

Yi-Chun Lin,1 Shih-Wei Li,2 Shin-Yen Ku,3 Hui-Ting Hsieh,3 Mei-Hui Lin,3 Shu-Yin Chang,3 Wei-Wei Wu,3 Na-Lee Sun,3 Shu-Hsing Cheng,1,4 Chien-Yu Cheng1,51Department of Internal Medicine, Division of Infectious Diseases, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan City, Taiwan; 2Division of Gastroenterology, Department of Internal Medicine, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan City, Taiwan; 3Comprehensive HIV Care Center, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan City, Taiwan; 4School of Public Health, Taipei Medical University, Taipei, Taiwan; 5School of Public Health, National Yang-Ming University, Taipei, TaiwanBackground and aims: We aimed to evaluate the efficacy and tolerability of grazoprevir/elbasvir in patients with chronic genotype 1 hepatitis C virus (HCV) and HIV co-infection who experienced peginterferon alfa plus ribavirin (PegIFN/RBV) (clinicaltrials.gov NCT03098121).Methods: This non-randomized, open-label trial study was conducted in Taoyuan General Hospital. HIV-infected patients were screened for HCV antibody since June 1, 2012, and HCV and HIV co-infected patients were tested for HCV RNA. The subjects who experienced PegIFN/RBV were enrolled in the study, and of whom with chronic genotype 1a or 1b received grazoprevir 100 mg and elbasvir 50 mg in a fixed-dose combination tablet once daily with or without ribavirin for 12 to 16 weeks.Results: Of 2,419 HIV-infected patients, 40 patients with chronic genotype 1 HCV and HIV co-infection who failed PegIFN/RBV treatment were enrolled. Sixteen patients had genotype 1a and 24 patients had genotype 1b, with or without cirrhosis. The median age was 42 (41–47) years, and 5 patients (12.5%) were diagnosed with liver cirrhosis (child Pugh score A). The median CD4 count was 504 cells/μL (321–689). All patients (100%) had HIV viral load 10 IU/mL (3.98–7.12). At the end of treatment, all patients (100%, 40/40) had undetectable HCV viral load, and 95.0% (38/40) of patients achieved sustained virologic response at 12 weeks.Conclusion: Grazoprevir/elbasvir was effective in genotype 1 patients co-infected with HIV with or without cirrhosis. This finding is consistent with that of previous trials of this regimen in monoinfected population.Keywords: hepatitis C, grazoprevir and elbasvir, PEGylated interferon plus ribavirin, direct-acting antiviral, HCV genotype 1, HCV/HIV co-infection

Keywords

• hepatitis C
• grazoprevir and elbasvir
• PEGylated interferon plus ribavirin
• direct-acting antiviral
• HCV genotype 1
• HCV/HIV co-infection