Monitoring SOF/VEL in Treatment Naïve, HCV Participants With Active Infection
Condition: Hepatitis C; HIV-1-infection; Liver Diseases
MeSH terms: Infections; Communicable Diseases; Hepatitis C; Liver Diseases
Intervention: Sofosbuvir/Velpatasvir (SOF/VEL); Minimal Monitoring (MINMON) Strategy
Intervention description: 400/100 mg fixed-dose combination (FDC) tablet administered orally once daily with or without food.; MINMON Strategy:
No pre-treatment HCV genotyping
Entire treatment course (84) tablets of SOF/VEL administered to participants at study entry
No scheduled on-treatment laboratory monitoring or clinic visits
Remote contact with participants at week 4 and week 22
Intervention MeSH terms: Sofosbuvir; Sofosbuvir-velpatasvir drug combination; Velpatasvir
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 400.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To achieve global hepatitis C virus (HCV) elimination by 2030, 80% of the ~71 million people
      with chronic HCV infection will need to be treated, necessitating simplification of treatment
      delivery and associated laboratory monitoring without compromising efficacy or safety. The
      COVID-19 pandemic has further highlighted the need for innovative models of health care
      delivery that minimize face-to-face patient-provider contact. The purpose of this study was
      to evaluate the feasibility, safety, and efficacy of a minimal monitoring (MINMON) strategy
      to deliver interferon- and RBV-free, pan-genotypic DAA therapy to treat active HCV in HCV
      treatment naïve participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Active Hepatitis C (HCV) infection, defined by HCV RNA >1000 international units
             (IU/mL) within 35 days prior to study entry

          -  HCV treatment naïve

          -  Liver disease staged as either non-cirrhotic (Fibrosis-4 (FIB-4) Score <3.25) or
             compensated cirrhotic (FIB-4 Score ≥3.25 and Child-Turcotte-Pugh (CTP) ≤Score 6)
             within 35 days prior to study entry

          -  HIV-1 negative, or HIV-1 positive with either a) Non-efavirenz containing
             antiretroviral therapy (ART) started at least 14 days prior to study entry with plasma
             HIV-1 RNA <400 copies/mL within 90 days prior to study entry or b) not taking ART and
             CD4+ cell count >350 cells/uL within 90 days prior to study entry

          -  The following laboratory values obtained within 35 days prior to study entry:

               -  Albumin >3.0 g/L

               -  Hemoglobin >8.0 g/dL for women; >9.0 g/dL for men

               -  Platelet count >50,000/mm^3

               -  Calculated creatinine clearance (CrCl) >30 mL/min

               -  Aspartate aminotransferase (AST) <10 times the upper limit of the normal range
                  (ULN)

               -  Alanine transaminase (ALT) <10 times the ULN

               -  Total bilirubin <1.5 times the ULN for participants not on atazanavir (ATV); <3
                  times the ULN for participants on ATV

               -  International normalized ratio (INR) <1.5 times the ULN

          -  For females of reproductive potential, a negative serum or urine pregnancy test within
             48 hours prior to study entry

          -  All participants of reproductive potential must have agreed not to participate in
             conception process (e.g., active attempt to become pregnant or to impregnate, sperm
             donation, in vitro fertilization) while on study treatment and for 6 weeks after
             stopping study treatment

          -  If participating in sexual activity that could lead to pregnancy, the all participants
             of reproductive potential had to agree to use at least one reliable methods of
             contraception while on study treatment and for 6 weeks after stopping study treatment

          -  Participants who were not of reproductive potential were eligible without requiring
             the use of contraceptives.

          -  Life expectancy >12 months

          -  Ability and willingness to be contacted remotely

          -  Ability and willingness of participant to provide informed consent.

        Exclusion Criteria:

          -  Positive for hepatitis B virus (HBV) surface antigen

          -  For cirrhotic participants, CTP score >6 corresponding to Class B or C

          -  Breastfeeding or pregnancy

          -  Known allergy/sensitivity or any hypersensitivity to components of study drugs or
             their formulation

          -  Active drug or alcohol use or dependence and other conditions that, in the opinion of
             the site investigator, would interfere with adherence to study requirements.

          -  Acute or serious illness requiring systemic treatment and/or hospitalization within 35
             days prior to study entry

          -  For HIV positive participants, presence of active or acute AIDS-defining opportunistic
             infections within 35 days prior to study entry

          -  Any history of hepatic decompensation including ascites, spontaneous bacterial
             peritonitis, hepatic encephalopathy, hepatorenal syndrome, and/or bleeding esophageal
             varices

          -  Use of prohibited medications within the past 14 days prior to study entry