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

Abstract

Background 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 <200 copies/mL, and HCV viral load was 6.3 log 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.

An observational, prospective, multicenter study on the utilization and effectiveness of elbasvir–grazoprevir treatment association for chronic hepatitis C in France (ZEPHYR study)

“…In addition, our data were consistent with data reported elsewhere by others in specific subgroups, in particular, in migrant populations or patients using OAT, including PWID, or those with a CKD Stages 3–5 12–18 . In addition, even if the number of patients was too low ( n = 4/0.9%) to analyze them as a subgroup according to the statistical analysis plan prepared before database lock, coinfection with HIV was not a barrier to achieving SVR12 as reported by others 19 . To date, this study is the first to explore in this setting, a broad set of PROs at treatment initiation and during follow‐up.…”

“…(n = 4/0.9%) to analyze them as a subgroup according to the statistical analysis plan prepared before database lock, coinfection with HIV was not a barrier to achieving SVR12 as reported by others. 19 To date, this study is the first to explore in this setting, a broad set of PROs at treatment initiation and during follow-up. The rate of PRO completion was very high all along the study as reported by others.…”

Well tolerability and highly effective treatment response for hepatitis C virus-human immunodeficiency virus–coinfected patients treated by all-oral direct-acting antivirals

“…3,4 Epidemiological data from different studies suggest that the seroprevalence of HCV in HIV-infected Taiwanese patients ranged from 18.6% to 43.4%. [5][6][7] The reported incidence of HCV-HIV coinfection among HIV-infected subpopulations is as follows: 13% in HIV-infected adolescents, 5.3% to 10.9% among adults with sexually transmitted HIV infection, and 65.5% to 100% among IDUs. 8 Several studies have demonstrated that HCV-HIV coinfection exerts a strong negative effect on the natural course of HCV infection, which include increase in HCV viral load and alanine aminotransferase (ALT) level, rapid liver fibrosis, and increased risk of hepatic decompensation and HCC development.…”

“…3,4 Epidemiological data from different studies suggest that the seroprevalence of HCV in HIV-infected Taiwanese patients ranged from 18.6% to 43.4%. 5–7 The reported incidence of HCV-HIV coinfection among HIV-infected subpopulations is as follows: 13% in HIV-infected adolescents, 5.3% to 10.9% among adults with sexually transmitted HIV infection, and 65.5% to 100% among IDUs. 8…”