Efficacy and Tolerability of Grazoprevir and Elbasvir in Patients With Chronic Genotype 1 HCV and HIV Co-infection

• Status: Completed
• Trial end date: 2018-11-30
• Target enrollment: 0
• Participant gender: All

Summary

This clinical study will evaluate whether grazoprevir and elbasvir is efficacious, safe, and well-tolerated in peginterferon alfa plus ribavirin experienced patients who inject drugs (PWID) and men who sex with men (MSM) with genotype 1 HCV and HIV co-infection.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taoyuan General Hospital
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Grazoprevir; Ribavirin

Criteria

Inclusion Criteria:

• Men and non-pregnant women, at least 20 years of age with chronic genotype 1 HCV and HIV co-infection.

• HCV RNA > 10,000 IU/mL

• Stable antiretroviral therapy (ARV) with confirmed plasma HIV-1 RNA < 200 copies/mL

• CD4 T-cell count > 100 cells/L

• peginterferon alfa plus ribavirin failure: null response <1 log10 IU/mL reduction in HCV RNA at week 4; detectable HCV RNA since week 12 to the end of treatment; detectable HCV RNA for 12 to 24 weeks after the end of treatment; or discontinuation of peginterferon alfa plus ribavirin due to grade 3 or grade 4 adverse effects at any moment.

Exclusion Criteria:

• Decompensated liver disease (presence or history of ascites, oesophageal or gastric variceal bleeding, hepatic encephalopathy, or other signs of advanced liver diseases)

• Liver cirrhosis with Child-Pugh class B or C, or with a Child-Turcotte-Pugh score of more than 6 points and albumin below 3 g/dL or platelet count below 75,000/ μL

• History of malignant disease, or evidence of hepatocellular carcinoma

• ARV with protease inhibitor containing regimen HBsAg and HBV core antibody should be checked in all patients. HBsAg positive patients should be excluded from the study. HBV core antibody positive patients should be closely monitored for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Appropriate patient management should be instituted for HBV infection as clinically indicated.