Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SOF · 14 trials · 8 indications
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) at 12 weeks after stopping study treatment.
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.
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ, ie, \< 25 IU/mL) 12 weeks following the last dose of study drug. Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group.
The percentage of participants experiencing an adverse event leading to permanent discontinuation of study drug(s) was analyzed.
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: 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/VOX | EXPERIMENTAL | SOF/VEL/VOX tablet for 8 weeks |
| 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 16 weeks | EXPERIMENTAL | SOF+RBV for 16 weeks |
| SOF+RBV 24 weeks | EXPERIMENTAL | SOF+RBV for 24 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+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. |
| SOF+RBV | EXPERIMENTAL | Participants will receive SOF+RBV for 48 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. |
| 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/VOX | DRUG | 400/100/100 mg tablet administered orally once daily with food |
| SOF/VEL | DRUG | 400/100 mg tablet administered orally once daily with or without food |
| Placebo | DRUG | Tablet administered orally once daily with food |
| SOF | DRUG | 400 mg tablet administered orally once daily |
| RBV | DRUG | Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) |
| 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 |
| 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 |
| LDV/SOF | DRUG | LDV/SOF fixed-dose combination (FDC) tablet administered once daily |
| 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: * Willing and able to provide written informed consent * HCV RNA ≥ 10\^4 IU/mL at screening * Chronic HCV infection (≥ 6 months) * HCV treatment naive or treatment experienced with an interferon (IFN)-based regimen * Use of protocol specified methods of contraception Key Ex...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Atea Pharmaceuticals, Inc. | AVIR | 2 | PHASE3 | Bemnifosbuvir-Ruzasvir, Sofosbuvir-Velpatasvir |
| Abbott Laboratories | ABT | 2 | - | Undisclosed |
| AbbVie, Inc. | ABBV | 1 | - | Undisclosed |
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.