Monitoring SOF/VEL in Treatment Naïve, HCV Participants With Active Infection

• Status: Completed
• Trial end date: 2021-02-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AIDS Clinical Trials Group
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Sofosbuvir; Sofosbuvir-velpatasvir drug combination; Velpatasvir

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