Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SOF/VEL/VOX · 2 trials · 1 indication
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.
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.
| Arm | Type | Description |
|---|---|---|
| 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/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. |
| Name | Type | Description |
|---|---|---|
| SOF | DRUG | Tablet(s) administered orally once daily |
| RBV | DRUG | 200 mg tablet administered orally once daily |
| LDV/SOF | DRUG | 90/400 mg fixed-dose combination (FDC) tablet administered orally once daily |
| SOF/VEL/VOX | DRUG | 400/100/100 mg FDC tablet 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 |
Key Inclusion Criteria: * Cohorts 1 and 2: chronic genotype 1 or 3 HCV infection * Cohort 3: chronic genotype 1 or 4 HCV infection * HCV RNA ≥ 10\^4 IU/mL at screening * Screening labs within defined thresholds * Cirrhosis determination at screening Key Exclusion Criteria: * Females who are pregn...
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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.