Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication VOSEVI is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis (Child-Pugh A) who have [see Dosage and Administration (2.2) and Clinical Studies (14) ]: genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an HCV regimen containing an NS5A inhibitor. FDA label
Also known as SOF, Vosevi ®, Epclusa®
SOF/VEL/VOX · 44 trials · 11 indications
SVR12 was defined as HCV RNA \< LLOQ (i.e., 15 IU/mL) at 12 weeks after stopping study treatment.
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) \< LLOQ (i.e., 15 IU/mL) at 12 weeks after stopping study treatment.
TEAEs were defined as any AEs with an onset date on or after the study drug start and no later than 30 days after permanent discontinuation of study drug and/or any AEs leading to premature discontinuation of the study drug.
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment.
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.
The percentage of participants permanently discontinuing any study drug due to an adverse event was summarized.
The percentage of participants experiencing an adverse event leading to permanent discontinuation of study drug(s) was analyzed.
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ, ie, \< 25 IU/mL) 12 weeks after cessation of therapy. For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm).
Adverse events which led to permanent discontinuation of study drug may or may not have been related to study treatment.
The number of subjects experiencing adverse events leading to permanent discontinuation of study drug was summarized. Adverse events may or may not have been related to study treatment.
AUCtau is defined as concentration of drug over time (the area under the concentration versus time curve over the dosing interval).
AUCtau is defined as concentration of drug over time (the area under the concentration versus time curve over the dosing interval).
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product, which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs were defined as 1 or both of the following: Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug and/or Any AEs leading to premature discontinuation of study drug.
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
SVR12 is defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Treatment-emergent laboratory abnormalities were defined as values that increased by at least 1 toxicity grade from baseline at any time postbaseline up to the date of last dose of study drug plus 30 days.
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Cmax is defined as the maximum concentration of drug.
Cmax is defined as the maximum concentration of drug.
Cmax is defined as the maximum concentration of drug.
Ctau is defined as the observed drug concentration at the end of the dosing interval.
Ctau is defined as the observed drug concentration at the end of the dosing interval.
Ctau is defined as the observed drug concentration at the end of the dosing interval.
Adverse events (AEs) occurring from baseline (Day 1 for all groups) to 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event.
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Cmax is defined as the maximum concentration of drug.
Cmax is defined as the maximum concentration of drug.
Cmax is defined as the maximum concentration of drug.
Cmax is defined as the maximum concentration of drug.
Ctau is defined as the observed drug concentration at the end of the dosing interval.
Ctau is defined as the observed drug concentration at the end of the dosing interval.
Ctau is defined as the observed drug concentration at the end of the dosing interval.
Ctau is defined as the observed drug concentration at the end of the dosing interval.
AUCtau: concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval). Data for this outcome measure were collected for participants in Part A only.
Cmax: maximum observed concentration of drug in plasma. Data for this outcome measure were collected for participants in Part A only.
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment. Data for this outcome measure were collected for participants in Part B only.
| Arm | Type | Description |
|---|---|---|
| SOF/VEL | EXPERIMENTAL | Participants with chronic HCV infection (genotype 1 or 2), who are treatment-naive or treatment-experienced with interferon (IFN)-based treatments will receive SOF/VEL for 12 weeks. |
| SOF/VEL/VOX | EXPERIMENTAL | Participants with chronic HCV infection (genotype 1), who are treatment-experienced with nonstructural protein 5A (NS5A) direct-acting antiviral (DAA)-based treatments of at least 4 weeks duration will receive SOF/VEL/VOX for 12 weeks. |
| SOF/VEL + RBV | EXPERIMENTAL | SOF/VEL + RBV for 12 weeks |
| SOF/VEL FDC + RBV 12 weeks | EXPERIMENTAL | SOF/VEL FDC + RBV for 12 weeks in participants with genotype 1 or 2 HCV infection |
| SOF/VEL FDC + RBV 24 weeks | EXPERIMENTAL | SOF/VEL FDC + RBV for 24 weeks in participants with genotype 1 or 2 HCV infection |
| SOF/VEL 12 weeks | ACTIVE_COMPARATOR | SOF/VEL tablet for 12 weeks |
| SOF/VEL/VOX (Primary Study) | EXPERIMENTAL | SOF/VEL/VOX for 12 weeks |
| Placebo (Primary Study) | EXPERIMENTAL | Placebo to match SOF/VEL/VOX for 12 weeks |
| SOF/VEL/VOX (Deferred Treatment Substudy) | EXPERIMENTAL | SOF/VEL/VOX for 12 weeks for eligible participants initially randomized to receive placebo |
| SOF+RBV | EXPERIMENTAL | SOF+RBV for 12 weeks |
| SOF+RBV 24 Weeks | EXPERIMENTAL | SOF+RBV for 24 weeks |
| Placebo | PLACEBO_COMPARATOR | SOF/VEL placebo for 12 weeks |
| SOF/VEL+RBV 12 weeks | EXPERIMENTAL | Participants will receive SOF/VEL FDC plus RBV for 12 weeks. |
| SOF/VEL 24 weeks | EXPERIMENTAL | Participants will receive SOF/VEL FDC for 24 weeks. |
| SOF+RBV 16 weeks | EXPERIMENTAL | SOF+RBV for 16 weeks |
| SOF+RBV+Peg-IFN 12 weeks | EXPERIMENTAL | SOF+RBV+Peg-IFN for 12 weeks |
| Retreatment Substudy | EXPERIMENTAL | Participants from the SOF+RBV arms (16 weeks or 24 weeks) who experienced virologic failure on treatment, or during the posttreatment period at or before Posttreatment Week 24 may be eligible to enroll into the Retreatment Substudy to receive SOF+RBV+Peg-IFN for 12 weeks. |
| SOF+RBV 12 Weeks | EXPERIMENTAL | Participants will receive SOF+RBV for 12 weeks. |
| Placebo 12 Weeks (GT2/3) | PLACEBO_COMPARATOR | Placebo to match SOF + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection. |
| SOF 12 Weeks (GT2/3) | EXPERIMENTAL | Placebo to match SOF + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection. |
| SOF 24 Weeks (GT3) | EXPERIMENTAL | SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection. |
| SOF+RBV 12 Weeks (GT 2/3, TN) | EXPERIMENTAL | Treatment-naive (TN) participants coinfected with HIV-1 and genotype (GT) 2 or genotype 3 HCV infection will receive SOF+RBV for 12 weeks. |
| SOF+RBV 24 Weeks (GT 2/3, TE) | EXPERIMENTAL | Treatment-experienced (TE) participants coinfected with HIV-1 and genotype 2 or genotype 3 HCV infection will receive SOF+RBV for 24 weeks. |
| SOF+RBV 24 Weeks (GT 1, TN) | EXPERIMENTAL | Treatment-naive (TN) participants coinfected with HIV-1 and genotype 1 HCV infection will receive SOF+RBV for 24 weeks. |
| SOF+RBV+placebo | EXPERIMENTAL | Participants were randomized to receive SOF+RBV for 12 weeks followed by placebo to match SOF plus placebo to match RBV for 4 weeks. |
| 12 to < 18 Years Old | EXPERIMENTAL | PK Lead-in Phase: Sofosbuvir/Velpatasvir (SOF/VEL) 400/100 mg once daily for 7 days. Participants who complete the PK lead-in phase, continue into the treatment phase with no interruption of study drug administration and additional participants will be enrolled into the treatment phase once the appropriateness of the dose is confirmed by PK results from the PK lead-in phase. Treatment Phase: SOF/VEL 400/100 mg once daily for 12 weeks. |
| 6 to < 12 Years Old | EXPERIMENTAL | PK Lead-in Phase: SOF/VEL 200/50 mg once daily for 7 days. Participants who complete the PK lead-in phase, continue into the treatment phase with no interruption of study drug administration and additional participants will be enrolled into the treatment phase once the appropriateness of the dose is confirmed by PK results from the PK lead-in phase. Treatment Phase: SOF/VEL 200/50 mg once daily for 12 weeks. |
| 3 to < 6 Years Old | EXPERIMENTAL | PK Lead-in Phase: SOF/VEL 200/50 mg once daily for 7 days for participants who weigh ≥ 17 kg. SOF/VEL 150/37.5 mg once daily for 7 days for participants who weigh \< 17 kg. Participants who complete the PK lead-in phase, continue into the treatment phase with no interruption of study drug administration and additional participants will be enrolled into the treatment phase once the appropriateness of the dose is confirmed by PK results from the PK lead-in phase. Treatment Phase: SOF/VEL 200/50 mg once daily for 12 weeks for participants who weigh ≥ 17 kg. SOF/VEL 150/37.5 mg once daily for 12 weeks for participants who weigh \< 17 kg. |
| SOF/VEL+ RBV | EXPERIMENTAL | SOF/VEL FDC plus RBV for 12 weeks |
| SOF/VEL/VOX + RBV | EXPERIMENTAL | SOF/VEL/VOX + RBV for 12 weeks |
| SOF/VEL+RBV | EXPERIMENTAL | Participants will receive SOF/VEL fixed dose combination (FDC) and RBV for 24 weeks. |
| 12 to < 18 Years Old, SOF+RBV 12 Weeks (GT 2) | EXPERIMENTAL | Participants between 12 to \< 18 years of age with genotype (GT) 2 HCV infection weighing ≥ 45 kg will receive SOF (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules based on swallowability assessment during screening) plus RBV (up to 1400 mg) for 12 weeks. |
| 12 to < 18 Years Old, SOF+RBV 24 Weeks (GT 3) | EXPERIMENTAL | Participants between 12 to \< 18 years of age with genotype 3 HCV infection weighing ≥ 45 kg will receive SOF (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules based on swallowability assessment during screening) plus RBV (up to 1400 mg) for 24 weeks. |
| 6 to < 12 Years Old, SOF+RBV 12 Weeks (GT 2) | EXPERIMENTAL | Participants between 6 to \< 12 years of age with genotype 2 HCV infection weighing ≥ 17 kg and \< 45 kg will receive SOF (2 x 100 mg tablets or 4 x 50 mg oral granules based on swallowability assessment during screening) plus RBV (up to 1400 mg) for 12 weeks. |
| 6 to <12 Years Old, SOF+RBV 24 Weeks (GT 3) | EXPERIMENTAL | Participants between 6 to \< 12 years of age with genotype 3 HCV infection weighing ≥ 17 kg and \< 45 kg will receive SOF (2 x 100 mg tablets or 4 x 50 mg oral granules based on swallowability assessment during screening) plus RBV (up to 1400 mg) for 24 weeks. |
| 3 to < 6 Years Old, SOF+RBV 12 Weeks (GT 2) | EXPERIMENTAL | Participants between 3 to \< 6 years of age with genotype 2 HCV infection weighing ≥ 17kg will receive SOF (4 x 50 mg oral granules) plus RBV (up to 1400 mg) for 12 weeks and those weighing \< 17 kg will receive SOF (3 x 50 mg oral granules) + RBV (up to 1400 mg) for 12 weeks. |
| 3 to < 6 Years Old, SOF+RBV 24 Weeks (GT 3) | EXPERIMENTAL | Participants between 3 to \< 6 years of age with genotype 2 HCV infection weighing ≥ 17kg will receive SOF (4 x 50 mg oral granules) plus RBV (up to 1400 mg) for 24 weeks and those weighing \< 17 kg will receive SOF (3 x 50 mg oral granules) + RBV (up to 1400 mg) for 24 weeks. |
| SOF 200 mg + RBV 200 mg (Cohort 1) | EXPERIMENTAL | Participants with genotype 1 or 3 HCV infection will receive SOF 200 mg (2 × 100 mg tablets) plus RBV once daily for 24 weeks. |
| SOF 400 mg + RBV 200 mg (Cohort 2) | EXPERIMENTAL | Participants with genotype 1 or 3 HCV infection will receive SOF 400 mg (4 × 100 mg tablets or 1 × 400 mg tablet) plus RBV once daily for 24 weeks. |
| LDV/SOF (Cohort 3) | EXPERIMENTAL | Participants with genotype 1 or 4 HCV infection will receive LDV/SOF once daily for 12 weeks. |
| SOF+VEL 25 mg (GT3) without cirrhosis | EXPERIMENTAL | Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 25 mg for 12 weeks. |
| SOF+VEL 25mg+RBV (GT3) without cirrhosis | EXPERIMENTAL | Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 25 mg plus RBV for 12 weeks. |
| SOF+VEL 100 mg (GT3) without cirrhosis | EXPERIMENTAL | Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 100 mg for 12 weeks. |
| SOF+VEL 100 mg+RBV (GT3) without cirrhosis | EXPERIMENTAL | Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 100 mg plus RBV for 12 weeks. |
| SOF+VEL 25 mg (GT3) with cirrhosis | EXPERIMENTAL | Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 25 mg for 12 weeks. |
| SOF+VEL 25 mg+RBV (GT3) with cirrhosis | EXPERIMENTAL | Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 25 mg plus RBV for 12 weeks. |
| SOF+VEL 100 mg (GT3) with cirrhosis | EXPERIMENTAL | Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 100 mg for 12 weeks. |
| SOF+VEL 100 mg+RBV (GT3) with cirrhosis | EXPERIMENTAL | Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 100 mg plus RBV for 12 weeks. |
| SOF+VEL 25 mg (GT1) | EXPERIMENTAL | Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg for 12 weeks. |
| SOF+VEL 25 mg+RBV (GT1) | EXPERIMENTAL | Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg plus RBV for 12 weeks. |
| SOF+VEL 100 mg (GT1) | EXPERIMENTAL | Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg for 12 weeks. |
| SOF+VEL 100 mg+RBV (GT1) | EXPERIMENTAL | Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg plus RBV for 12 weeks. |
| SOF+VEL 25 mg 12 Weeks (GT1) | EXPERIMENTAL | Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg for 12 weeks. |
| SOF+VEL 100 mg 12 Weeks (GT1) | EXPERIMENTAL | Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg for 12 weeks. |
| SOF+VEL 25 mg 12 Weeks (GT2/4/5/6) | EXPERIMENTAL | Participants with genotype 2, 4, 5, or 6 HCV infection will receive SOF+VEL 25 mg for 12 weeks. |
| SOF+VEL 100 mg 12 Weeks (GT2/4/5/6) | EXPERIMENTAL | Participants with genotype 2, 4, 5, or 6 HCV infection will receive SOF+VEL 100 mg for 12 weeks. |
| SOF+VEL 25 mg 12 Weeks (GT3) | EXPERIMENTAL | Participants with genotype 3 HCV infection will receive SOF+VEL 25 mg for 12 weeks. |
| SOF+VEL 100 mg 12 Weeks (GT3) | EXPERIMENTAL | Participants with genotype 3 HCV infection will receive SOF+VEL 100 mg for 12 weeks. |
| SOF+VEL 25 mg 8 Weeks (GT1) | EXPERIMENTAL | Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg for 8 weeks. |
| SOF+VEL 25 mg + RBV 8 Weeks (GT1) | EXPERIMENTAL | Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg plus RBV for 8 weeks. |
| SOF+VEL 100 mg 8 Weeks (GT1) | EXPERIMENTAL | Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg for 8 weeks. |
| SOF+VEL 100 mg + RBV 8 Weeks (GT1) | EXPERIMENTAL | Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg plus RBV for 8 weeks. |
| SOF+VEL 25 mg 8 Weeks (GT2) | EXPERIMENTAL | Participants with genotype 2 HCV infection will receive SOF+VEL 25 mg for 8 weeks. |
| SOF+VEL 25 mg + RBV 8 Weeks (GT2) | EXPERIMENTAL | Participants with genotype 2 HCV infection will receive SOF+VEL 25 mg plus RBV for 8 weeks. |
| SOF+VEL 100 mg 8 Weeks (GT2) | EXPERIMENTAL | Participants with genotype 2 HCV infection will receive SOF+VEL 100 mg for 8 weeks. |
| SOF+VEL 100 mg + RBV 8 Weeks (GT2) | EXPERIMENTAL | Participants with genotype 2 HCV infection will receive SOF+VEL 100 mg plus RBV for 8 weeks. |
| SOF+PEG+RBV | EXPERIMENTAL | Participants will receive SOF+PEG+RBV for 12 weeks. |
| Observation, then SOF+RBV | EXPERIMENTAL | Participants will undergo 24 weeks of observation and then receive SOF+RBV for 48 additional weeks. |
| Group 1: SOF+RBV 12 wk: GT 2 or 3, TN | EXPERIMENTAL | Treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks. |
| Group 2: SOF+RBV 12 wk+PEG 4 wk: GT 2 or 3, TN | EXPERIMENTAL | Treatment-naive participants with genotype 2 or 3 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks. |
| Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN | EXPERIMENTAL | Treatment-naive participants with genotype 2 or 3 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks. |
| Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN | EXPERIMENTAL | Treatment-naive participants with genotype 2 or 3 HCV infection will receive SOF 400 mg once daily+weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks. |
| Group 5: SOF 12 wk: GT 2 or 3, TN | EXPERIMENTAL | Treatment-naive participants with genotype 2 or 3 HCV infection will receive SOF 400 mg once daily for 12 weeks. |
| Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN | EXPERIMENTAL | Treatment-naive participants with genotype 2 or 3 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks. |
| Group 7: SOF+RBV 12 wk: GT 1, TE | EXPERIMENTAL | Treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks. |
| Group 8: SOF+RBV 12 wk: GT 1, TN | EXPERIMENTAL | Treatment-naive participants with genotype 1 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks. |
| Group 9: SOF+RBV 12 wk: GT 2 or 3, TE | EXPERIMENTAL | Treatment-experienced participants with genotype 2 or 3 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks. |
| Group 10: SOF+RBV 8 wk: GT 2 or 3, TN | EXPERIMENTAL | Treatment-naive participants with genotype 2 or 3 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks. |
| Group 11: SOF+RBV 12 wk: GT 2 or 3, TN | EXPERIMENTAL | Treatment-naive participants with genotype 2 or 3 HCV infection will receive SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks. |
| Group 12: SOF+RBV+LDV 12 wk: GT 1, TE | EXPERIMENTAL | Treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks. |
| Group 13: SOF+RBV+LDV 12 wk: GT 1, TN | EXPERIMENTAL | Treatment-naive participants with genotype 1 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks. |
| Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE | EXPERIMENTAL | Treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks. |
| Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN | EXPERIMENTAL | Treatment-naive participants with genotype 1 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks. |
| Group 16: LDV/SOF FDC 12 wk: GT 1, fibrosis | EXPERIMENTAL | Treatment-experienced participants with genotype 1 HCV infection and Stage F4 fibrosis who did not respond to prior treatment will receive LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks. |
| Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, fibrosis | EXPERIMENTAL | Treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment will receive LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks. |
| Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN | EXPERIMENTAL | Treatment-naive participants with genotype 2 or 3 HCV infection will receive LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks. |
| Group 19: LDV/SOF FDC 12 wk: GT 2 or 3, TE | EXPERIMENTAL | Treatment-experienced participants with genotype 2 or 3 HCV infection will receive LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks. |
| Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, hemophiliac | EXPERIMENTAL | Hemophiliac participants with genotype 1 HCV infection will receive LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks. |
| Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN | EXPERIMENTAL | Treatment-naive participants with genotype 1 HCV infection will receive LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks. |
| Group 22: LDV/SOF FDC 6 wk: GT 1, TN | EXPERIMENTAL | Treatment-naive participants with genotype 1 HCV infection were randomized to receive LDV 90 mg/SOF 400 mg FDC once daily for 6 weeks. |
| SOF/VEL/VOX + VOX | EXPERIMENTAL | Part A: Participants without a documented history of taking norgestimate/ethinyl estradiol for at least one menstrual cycle will receive norgestimate/ethinyl estradiol. Participants with a documented history of taking norgestimate/ethinyl estradiol may enroll directly into Part B of the study. Part B: Participants will continue taking norgestimate/ethinyl estradiol for the remainder of the study and will receive SOF/VEL/VOX FDC plus VOX. |
| Part A: SOF+EFV/FTC/TDF (Cohort 1) | EXPERIMENTAL | Participants with a prestudy regimen of EFV/FTC/TDF will receive SOF+EFV/FTC/TDF FDC for 7 days, followed by EFV/FTC/TDF FDC (or EFV+FTC/TDF) for 7 days, coadministered once daily in the evening under fasting conditions. |
| Part A: SOF+EFV+ZDV/3TC (Cohort 2) | EXPERIMENTAL | Participants with a prestudy regimen of EFV+ZDV/3TC will receive SOF+EFV+ZDV/3TC for 7 days followed by EFV+ZDV/3TC for 7 days. Sofosbuvir and EFV will be administered once daily in the evening under fasting conditions; ZDV/3TC will be administered twice daily, in the morning without regard to food and in the evening on an empty stomach. |
| Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3) | EXPERIMENTAL | Participants with a prestudy regimen of RTV+ATV+FTC/TDF will receive SOF+RTV+ATV+FTC/TDF for 7 days followed by RTV+ATV+FTC/TDF for 7 days coadministered once daily in the morning with food. |
| Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4) | EXPERIMENTAL | Participants with a prestudy regimen of RTV+DRV+FTC/TDF will receive SOF+RTV+DRV+FTC/TDF for 7 days followed by RTV+DRV+FTC/TDF for 7 days coadministered once daily in the morning with food. |
| Part A: SOF+RAL+FTC/TDF (Cohort 5) | EXPERIMENTAL | Participants with a prestudy regimen of RAL+FTC/TDF will receive SOF+RAL+FTC/TDF for 7 days followed by RAL+FTC/TDF for 7 days. Sofosbuvir and FTC/TDF will be administered once daily in the morning with food; RAL will be administered twice daily, in the morning with food and in the evening without regard to food. |
| Part B: SOF+PEG+RBV | EXPERIMENTAL | Participants will receive SOF+PEG+RBV for 12 weeks. |
| Name | Type | Description |
|---|---|---|
| SOF/VEL | DRUG | 400/100 mg FDC tablet orally once daily. |
| SOF/VEL/VOX | DRUG | 400/100/100 mg FDC tablet orally once daily. |
| RBV | DRUG | Capsules administered orally in a divided daily dose |
| Placebo | DRUG | Tablet administered orally once daily with food |
| SOF | DRUG | SOF 400 mg tablet administered orally once daily |
| Peg-IFN | DRUG | 180 µg administered via subcutaneous injection once weekly |
| Placebo to match SOF | DRUG | Placebo to match SOF administered orally once daily |
| Placebo to match RBV | DRUG | Placebo to match RBV administered orally in a divided daily dose |
| LDV/SOF | DRUG | 90/400 mg fixed-dose combination (FDC) tablet administered orally once daily |
| VEL | DRUG | Tablet administered orally once daily |
| PEG | DRUG | Peginterferon alfa 2a (PEG) 180 μg administered once weekly by subcutaneous injection |
| LDV | DRUG | Ledipasvir (LDV) tablets administered orally once daily |
| GS-9669 | DRUG | GS-9669 tablets administered orally once daily |
| VOX | DRUG | 100 mg tablet administered orally once daily |
| Norgestimate/ethinyl estradiol | DRUG | Norgestimate 0.180 mg/0.215 mg/0.25 mg/ethinyl estradiol 0.025 mg tablet administered orally once daily according to the package insert |
| EFV/FTC/TDF | DRUG | Efavirenz (EFV) 600 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg fixed-dose combination (FDC) tablet administered orally once daily |
| EFV | DRUG | Efavirenz (EFV) 600 mg tablet administered orally once daily |
| ZDV/3TC | DRUG | Zidovudine (ZDV) 300 mg/lamivudine (3TC) 150 mg FDC tablet administered orally twice daily |
| ATV | DRUG | Atazanavir (ATV) 400 mg tablet administered orally once daily |
| Ritonavir | DRUG | Ritonavir (RTV) 100 mg tablet administered orally once daily |
| FTC/TDF | DRUG | FTC/TDF (200/300 mg) FDC tablet administered orally once daily |
| DRV | DRUG | Darunavir (DRV) 800 mg (2 × 400 mg tablets) administered orally once daily |
| RAL | DRUG | Raltegravir (RAL) 400 mg administered administered orally twice daily |
Key Inclusion Criteria: * Chronic HCV infected males and non-pregnant/non-lactating females * Treatment-naive or treatment-experienced individuals * Non-cirrhosis or compensated cirrhosis at screening Note: Other protocol defined Inclusion/Exclusion criteria may apply.
SOF/VEL/VOX is a fixed-dose combination small molecule developed by Gilead Sciences, Inc. (ticker: GILD) for the treatment of chronic hepatitis C virus infection. It combines sofosbuvir, velpatasvir, and voxilaprevir. It is given as a 12-week oral regimen in adults with chronic HCV infection.
SOF/VEL/VOX is used to treat chronic hepatitis C virus infection in adults. Its clinical program covers chronic HCV infection, including patients with compensated cirrhosis and those who participated in prior Gilead-sponsored HCV treatment studies. It is studied as a 12-week fixed-dose combination regimen.
SOF/VEL/VOX is developed by Gilead Sciences, Inc., which trades under the ticker GILD. Gilead sponsored the Phase 3 trials of the fixed-dose combination, including studies conducted in the United States, South Korea, Japan, India, Australia, Canada, France, Germany, New Zealand, and the United Kingdom.
SOF/VEL/VOX has been studied in Phase 3 clinical development. All 24 of its recorded trials are completed, with no active trials, and the program has enrolled a total of 4,369 participants. The trials were randomized, double-blind, and placebo-controlled.
SOF/VEL/VOX has been evaluated in completed Phase 3 trials including NCT04211909 in South Korea, NCT03118843 across the United States, Australia, Canada, France, Germany, New Zealand, and the United Kingdom, and NCT04112303 in Japan. A related Phase 3 study, NCT03074331, evaluated the sofosbuvir/velpatasvir fixed-dose combination in India.