Clinical trial NCT02785666 (phase 3, status: completed)
Conditions: hepatitis c, hiv
ICD codes: B18.2, B17.10, B17.11, B19.20, B19.21, B15.0, B15.9, B20, Z71.7, O98.72, Z21, O98.73, R75, Z11.4
Drugs: grazoprevir/elbasvir, ribavirin
SMILES: NC(=O)C1=NN(C=N1)[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O
Eligibility 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).