Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SOF/VEL · 28 trials · 2 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) 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) 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.
| 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+RBV | EXPERIMENTAL | SOF+RBV for 12 weeks |
| SOF/VEL 12 Weeks | EXPERIMENTAL | SOF/VEL FDC 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 12 Weeks | EXPERIMENTAL | SOF+RBV for 12 weeks |
| SOF+RBV+Peg-IFN 12 Weeks | EXPERIMENTAL | SOF+RBV+Peg-IFN for 12 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. |
| 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 |
| SOF | DRUG | SOF 400 mg tablet administered orally once daily |
| Placebo | DRUG | Tablet administered orally once daily |
| Peg-IFN | DRUG | Peg-IFN 180 μg administered once weekly by subcutaneous injection |
| Placebo to match SOF | DRUG | Placebo to match SOF was administered orally once daily. |
| Placebo to match RBV | DRUG | Placebo to match RBV was 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 is an investigational small molecule being developed for the treatment of Hepatitis C Virus (HCV) infection, including chronic hepatitis C. It is studied in patients with various HCV genotypes, including those with cirrhosis. The drug is currently in Phase 2 clinical development.
SOF is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol GILD. Gilead is conducting clinical trials to evaluate the efficacy and safety of SOF in patients with chronic hepatitis C virus infection.
SOF is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. All 24 clinical trials for SOF have been completed, with no active trials ongoing at this time.
SOF has been studied in 24 completed clinical trials. Notable Phase 2 trials include NCT01260350, evaluating SOF with ribavirin and pegylated interferon in treatment-naive patients with HCV genotypes 2 or 3, and NCT02300103, studying sofosbuvir/velpatasvir with ribavirin in chronic HCV patients.
SOF is the abbreviation for sofosbuvir, a nucleotide analog polymerase inhibitor. In clinical trials, it is often studied as part of fixed-dose combinations, such as sofosbuvir/velpatasvir, for the treatment of chronic hepatitis C virus infection.