Scale-up of Treatment of Hepatitis C Infection Among People Who Inject Drugs
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: Grazoprevir/elbasvir
Intervention description: Grazoprevir/elbasvir (100mg/50mg) once daily for 12 weeks.
Intervention MeSH terms: Grazoprevir; Elbasvir-grazoprevir drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is a phase IV, open-label, single arm, multicentre study whose aim is to assess
      whether interferon-free and ribavirin-free Direct Acting Antiviral (DAA) Hepatitis C Virus
      (HCV) therapy with grazoprevir/elbasvir, will be feasible for the treatment of People who
      inject drugs (PWID) with recent injecting drug use or people receiving opioid substitution
      therapy and chronic HCV genotype 1 or 4 infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants have voluntarily signed the informed consent form.

          -  Be ≥18 years of age on day of signing informed consent form.

          -  Have chronic HCV genotype 1 or 4 infection (defined as detectable HCV RNA).

          -  Recent injecting drug use (previous 6 months) or receiving opioid substitution
             therapy.

          -  HIV-1 infected subjects enrolled in the study must meet the following criteria:

               -  Have HIV infection documented by any licensed rapid HIV test or HIV enzyme or
                  chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry
                  (Baseline) and confirmed by a licensed Western blot or a second antibody test by
                  a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 p24 antigen,
                  or plasma HIV-1 RNA viral load

               -  b) Be on HIV Antiretroviral Therapy (ART) for at least 4 weeks prior to study
                  entry using an ART regimen that is allowable with the intended DAA regimen as
                  determined by the current PI and the Liverpool drug interaction website
                  (http://www.hiv-druginteractions.org/) or current prescribing guidelines for
                  elbasvir/grazoprevir OR be naive to treatment with any antiretroviral therapy
                  (ART) with a baseline CD4 count of >200 and have no plans to initiate ART
                  treatment while participating in this study and through to at least Follow-up
                  Week 4.

          -  Negative pregnancy test at screening and baseline (females of childbearing potential
             only).

          -  All fertile males and females must be using effective contraception during treatment
             and during 14 days after treatment end.

        Exclusion Criteria:

          -  Is taking or plans to take any prohibited medications as per DAA Product Information
             or herbal supplements, including but not limited to St. John's Wort (Hypericum
             perforatum) within 2 weeks of Baseline.

          -  Is currently using or intends to use barbiturates.

          -  Is a female and is pregnant or breast-feeding, or expecting to conceive or donate eggs
             from Baseline and continue throughout treatment, and after the last dose of study
             medication (as per the regimen requirements), or longer if dictated by local
             regulations.

          -  Has any condition or pre-study laboratory abnormality, ECG abnormality or history of
             any illness, which, in the opinion of the investigator, might confound the results of
             the study or pose additional risk in administering the study drugs to the subject.

          -  Had a life-threatening SAE during the screening period.

          -  Has exclusionary laboratory values as listed below:

               -  Haemoglobin < 9.5 g/dL for both males and females

               -  Platelets < 50 x 10^3 /µL

               -  Serum albumin < 3.0 g/dL

          -  Patients with Child Pugh-B or C decompensated cirrhosis

          -  Previous HCV treatment-experience.

          -  Ongoing severe psychiatric disease as judged by the treating physician.

          -  Frequent injecting drug use that is judged by the treating physician to compromise
             treatment safety.

          -  Inability or unwillingness to provide informed consent or abide by the requirements of
             the study.

          -  Is Hepatitis B surface antigen (HBsAg) positive

        NOTE: Sanger sequencing will be performed on a pre-treatment sample on all participants.