Swiss HCVree Trial

• Status: Completed
• Trial end date: 2018-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

The investigators aim at investigating the efficacy of grazoprevir/elbasvir ±ribavirin in HIV-positive MSM participating in the SHCS in a broader setting of coinfected MSM. The study pursues a comprehensive approach of a treat, counsel and cure strategy exploring the impact of such a strategy in a representative HIV/HCV-coinfected MSM population. This study is a nested project of the Swiss HIV Cohort Study entitled "The Swiss HCVree Trial".

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Zurich
• Treatments: Grazoprevir; Ribavirin

Criteria

Inclusion Criteria:

• Informed consent documented by signature

• Participation in the SHCS

• Male individual ≥18 years old

• Homosexual or bisexual preference/transmission mode according to the SHCS entry state and/or in the opinion of the study physician.

• Replicating HCV infection (i.e., positive HCV-RNA-test).

• HCV GT 1 and/or 4 infection.

Exclusion Criteria:

• Contraindications to grazoprevir/elbasvir and ribavirin due to significant drug-drug interactions (DDI) (e.g., HIV protease inhibitors) according to the Liverpool drug-interaction data base.

• Contraindications to grazoprevir/elbasvir and ribavirin, e.g. known hypersensitivity or allergy to the class of drugs or the investigational product.

• Participant is under the age of legal consent, is mentally or legally incapacitated, has significant emotional problems at the time of pre-study screening visit or expected during the conduct of the study or has a history of a clinically significant psychiatric disorder which, in the opinion of the investigator, would interfere with the study procedures.

• Inability to follow the study procedures (e.g. language barriers, psychiatric disorders

• Known or suspected non-adherence to study-procedures.

• Currently participating or has participated in a study with an investigational compound within 30 days of signing informed consent and is not willing to refrain from participating in another such study during the course of this study.

• Enrolment of the investigator, his/her family members, employees and other dependent persons.

• Participant suffers from clinically significant concomitant diseases (for the detailed list of diseases we refer to the according section of this protocol).

• Participant has a history of malignancy ≤5 years prior to signing informed consent or is under evaluation for other active or suspected malignancy.

• Participant has a history of opportunistic infection in the preceding 6 months prior to screening.

• Participants with mixed HCV infection of genotype 1, 4 or 6 with genotype 2, 3 or 5.

• Participant is coinfected with HBV-DNA positive hepatitis B virus (of note, HBsAg positive individuals with suppressed HBV-DNA might be included).

• Participant has evidence of decompensated liver disease.

• Liver cirrhosis Child-Pugh Class B or C, or who have a Pugh-Turcotte (CPT) score >5,

• Participant has cirrhosis and liver imaging within 6 months of Day 1 showing evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC.

• Participant has clinically-relevant drug or alcohol abuse at the PI's discretion within 12 months of screening.

• Participant is a male whose female partner(s) is/are pregnant (this is a contraindication for ribavirin use)

• Participant has exclusionary laboratory values at the screening visit (for the table containing these laboratory values we refer to the according section of this protocol).