Intervention: Epclusa
Trial phase: Phase 4
ATC code: J05AP55
SMILES: CC(C)OC(=O)C(C)NP(=O)(OCC1OC(n2ccc(=O)[nH]c2=O)C(C)(F)C1O)Oc1ccccc1.COCC1CC(c2ncc(-c3ccc4c(c3)COc3cc5c(ccc6[nH]c(C7CCC(C)N7C(=O)C(NC(=O)OC)C(C)C)nc65)cc3-4)[nH]2)N(C(=O)C(NC(=O)OC)c2ccccc2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 397
Group description: Participants received Sofosbuvir/Velpatasvir (SOF/VEL [Tradename: Epclusa®]) tablet for 12 weeks with a minimal monitoring (MINMON) strategy for 24 weeks

Sofosbuvir/Velpatasvir (SOF/VEL): 400/100 mg fixed-dose combination (FDC) tablet administered orally once daily with or without food.

Minimal Monitoring (MINMON) Strategy: 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
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