Chronic Hepatitis C
Conditions
Brief 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.
Detailed description
Primary Objective •To assess the efficacy of grazoprevir 100mg and elbasvir 50mg by determining the proportion of sustained virological response 12 weeks after the end of therapy (SVR12; HCV RNA concentration less than 10 IU/ mL at follow-up week 12) in peginterferon alfa plus ribavirin experienced patients with genotype 1 HCV and HIV co-infection, compared with treatment-naïve patients with 1 HCV and HIV co-infection. Secondary Objective •To assess the tolerability of grazoprevir 100mg and elbasvir 50mg in peginterferon alfa plus ribavirin experienced patients by measuring frequency of SAEs and AEs leading to discontinuation.
Interventions
DRUGgrazoprevir and elbasvir
For patients with chronic genotype 1a, with or without resistance associated variant (RAV) of NS5A, are expected to receive grazoprevir and elbasvir in a fixed-dose combination tablet once daily with ribavirin for 16 weeks, and for patients with chronic genotype 1b are expected to receive grazoprevir and elbasvir in a fixed-dose combination tablet once daily for 12 weeks.
Sponsors
Merck Sharp & Dohme LLC
Taoyuan General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sustained virological response | 12 weeks after the end of therapy | The proportion of sustained virological response 12 weeks after the end of therapy after the treatment of grazoprevir and elbasvir |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severe adverse effects | during the treatment of grazoprevir and elbasvir | The frequency of severe adverse effects leading to discontinuation |
Countries
Taiwan
Outcome results
None listed