Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02607800 | Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir and Sofosbuvir/Velpatasvir in Adults With Chronic HCV Infection Who Have Not Previously Received Treatment With Direct-Acting Antiviral Therapy | PHASE3 | COMPLETED | 943 | — | — | Nov 16, 2015 | Jan 11, 2017 | Mar 5, 2019 | 93 | United States, Australia +6 |
| NCT02607735 | Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir in Adults With Chronic HCV Infection Who Have Previously Received Treatment With Direct-Acting Antiviral Therapy | PHASE3 | COMPLETED | 416 | — | — | Nov 11, 2015 | Jun 21, 2017 | Mar 5, 2019 | 86 | United States, Australia +6 |
| NCT01962441 | SOF (Sovaldi®) +RBV for 16 or 24 Weeks and SOF+RBV+Peg-IFN for 12 Weeks in Adults With Genotype 2 or 3 Chronic HCV Infection | PHASE3 | COMPLETED | 601 | — | — | Sep 24, 2013 | Jul 7, 2016 | Jun 20, 2017 | 78 | United States, Australia +3 |
| NCT01896193 | Safety and Efficacy Study of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Genotype 1 and 3 Chronic HCV Infection | PHASE3 | COMPLETED | 127 | — | — | Jun 1, 2013 | Jun 1, 2014 | May 29, 2015 | 16 | Russia |
| NCT01682720 | Sofosbuvir and Ribavirin in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection | PHASE3 | COMPLETED | 421 | — | — | Sep 1, 2012 | Jan 1, 2014 | Oct 9, 2014 | 77 | Austria, Estonia +8 |
| NCT01667731 | Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2 and 3 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Adults | PHASE3 | COMPLETED | 224 | — | — | Jul 1, 2012 | Feb 1, 2014 | Nov 21, 2014 | 27 | United States, Puerto Rico |
| NCT01909804 | Safety and Efficacy of Sofosbuvir Plus Velpatasvir With or Without Ribavirin in Treatment-experienced Subjects With Chronic HCV Infection | PHASE2 | COMPLETED | 323 | — | — | Jun 1, 2013 | Aug 1, 2014 | Nov 15, 2018 | 49 | United States, Australia +2 |
| NCT01858766 | Safety and Efficacy of Sofosbuvir + Velpatasvir With or Without Ribavirin in Treatment-Naive Adults With Chronic HCV Infection | PHASE2 | COMPLETED | 379 | — | — | Apr 1, 2013 | Aug 1, 2014 | Nov 14, 2018 | 51 | United States, Puerto Rico |
| NCT01808248 | Sofosbuvir (GS-7977) in Combination With PEG and Ribavirin for 12 Weeks in Treatment Experienced Subjects With Chronic HCV Infection Genotype 2 or 3 | PHASE2 | COMPLETED | 47 | — | — | Feb 1, 2013 | Dec 1, 2013 | Sep 12, 2014 | 1 | United States |
| NCT01687257 | Sofosbuvir and Ribavirin in Patients With Chronic HCV With Cirrhosis and Portal Hypertension With or Without Liver Decompensation | PHASE2 | COMPLETED | 50 | — | — | Jul 1, 2012 | Oct 1, 2015 | Sep 16, 2016 | 9 | United States, Australia +3 |
| NCT01565889 | Part A: Drug Interaction Study of Sofosbuvir and Antiretroviral Therapy (ART) Combinations in HIV and Hepatitis C Virus (HCV) Co-infected Patients. Part B: Efficacy and Safety of Sofosbuvir for 12 Weeks in HIV/HCV Co-infected Patients. | PHASE1 | COMPLETED | 52 | — | — | Mar 1, 2012 | Nov 1, 2013 | Oct 1, 2014 | 1 | Puerto Rico |
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.
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. |
| 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. |
| 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 |
| 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 |