Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Sofosbuvir · 13 trials · 11 indications
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) 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.
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; \< 25 IU/mL) 12 weeks after study drug cessation.
Measured by the portion of subjects with sustained virological response (undetectable HCV RNA)
Subjects with chronic hepatitis B will be give 12 weeks of ledipasvir and/or sofosbuvir and their HBsAg will be measured at baseline, on each visits during therapy, and at end of therapy (week 12). The change (decline) in HBsAg from baseline to end of the 12 week treatment will be compared.
Number of subjects who discontinued study drug due to adverse event
Measured by the proportion of subjects who become HEV RNA negative (HEV RNA undetectable)
pTVR was defined as HCV RNA \< the lower limit of quantification (LLOQ, ie, 25 mL/IU) at Week 12 after transplant.
* Treatment-emergent deaths were those that occurred while taking study drug or to the minimum of 1) date of transplantation, 2) retreatment 1st dose date, or 3) last dose date + 30 days. * Only those participants who underwent liver transplantation were analyzed for death post-transplantation.
SVR12 was defined as HCV RNA \< LLOQ 12 weeks after the last dose of all study drugs.
SVR24 was defined as HCV RNA \< the limit of detection (LOD; \< 15 IU/mL) 24 weeks after the last dose of study drug.
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.
Adverse events (AEs) occurring during the sofosbuvir treatment period and for 30 days following the last dose of sofosbuvir were summarized across the participant population. A participant was counted once if they had a qualifying event.
| Arm | Type | Description |
|---|---|---|
| Sofosbuvir+RBV 16 weeks | EXPERIMENTAL | Participants with HCV genotypes 1 and 3 will receive sofosbuvir plus ribavirin for 16 weeks. |
| Sofosbuvir+RBV 24 weeks | EXPERIMENTAL | Participants with HCV genotypes 1 and 3 will receive sofosbuvir plus ribavirin for 24 weeks. |
| Sofosbuvir+RBV+PEG 12 weeks | EXPERIMENTAL | Participants with genotype 1 or 6 will receive sofosbuvir+RBV+Peg-IFNα-2a for 12 weeks. |
| Sofosbuvir+RBV 12 weeks | EXPERIMENTAL | Participants with genotype 1, 2 or 6 will receive sofosbuvir+RBV for 12 weeks. |
| Sofosbuvir+RBV | EXPERIMENTAL | Participants were randomized to receive sofosbuvir+RBV for 12 weeks. |
| PEG+RBV | ACTIVE_COMPARATOR | Participants were randomized to receive PEG+RBV for 24 weeks. |
| Sofosbuvir and Velpatasvir | EXPERIMENTAL | SOF/VEL FDC film-coated tablet, oral, SOF 400 mg/VEL 100 mg daily, 8 weeks |
| Group A (LDV/SOF for low replicative HBV) | EXPERIMENTAL | 12 week treatment with ledipasvir/sofosbuvir (Harvoni) for chronic hepatitis B in low replicative state. |
| Group B (LDV/SOF for viral suppressed HBV) | EXPERIMENTAL | 12 week treatment with ledipasvir/sofosbuvir (Harvoni) for chronic hepatitis B, virally suppressed. |
| Group C (SOF for low replicative HBV) | EXPERIMENTAL | 12 weeks treatment with sofosbuvir (Sovaldi) for chronic hepatitis B in low replicative state. Randomized 1:1 with Group D. |
| Group D (LDV for low replicative HBV) | EXPERIMENTAL | 12 weeks treatment with ledipasvir for chronic hepatitis B in low replicative state. Randomized 1:1 with Group C. |
| Sofosbuvir | EXPERIMENTAL | Sofosbuvir 400 MG film-coated tablet, oral administration of one tablet once daily for 24 weeks. |
| SOF+RBV | EXPERIMENTAL | Participants will receive sofosbuvir+RBV for 24 weeks. |
| SOF+RBV 12 Weeks | EXPERIMENTAL | Participants were randomized to receive sofosbuvir plus RBV plus placebo to match GS-0938 for 12 weeks. |
| SOF+RBV 24 Weeks | EXPERIMENTAL | Participants were randomized to receive sofosbuvir plus RBV plus placebo to match GS-0938 for 24 weeks. |
| GS-0938 Alone | EXPERIMENTAL | Participants were randomized to receive GS-0938 plus placebo to match sofosbuvir for up to 24 weeks. |
| GS-0938+SOF | EXPERIMENTAL | Participants were randomized to receive GS-0938 plus sofosbuvir for up to 24 weeks. |
| GS-0938+SOF+RBV | EXPERIMENTAL | Participants were randomized to receive GS-0938 plus sofosbuvir plus RBV for up to 24 weeks. |
| Placebo | EXPERIMENTAL | Deferred start group: Participants were randomized to receive placebo to match GS-0938 plus placebo to match sofosbuvir for 24 Weeks. |
| Retreatment Group - SOF+RBV 24 Weeks | EXPERIMENTAL | After discontinuing a regimen containing GS-0938, participants received sofosbuvir plus RBV for up to 24 weeks. |
| SOF+PEG+RBV 12 weeks | EXPERIMENTAL | Participants were randomized to receive sofosbuvir+PEG+RBV for 12 weeks. |
| SOF+PEG+RBV 24 weeks | EXPERIMENTAL | Participants were randomized to receive sofosbuvir+PEG+RBV for 24 weeks. |
| SOF+PEG+RBV 12 week/Rerandomization Group | EXPERIMENTAL | Participants were randomized to receive sofosbuvir+PEG+RBV for 12 weeks, then were rerandomized to receive sofosbuvir only or sofosbuvir+RBV for 12 additional weeks. |
| Sofosbuvir 200 mg (Genotype 1) | EXPERIMENTAL | Participants with genotype 1 HCV infection were randomized to receive sofosbuvir 200 mg (2 x 100 mg tablets)+placebo to match sofosbuvir (2 tablets)+PEG+RBV for 12 weeks followed by PEG+RBV for up to an additional 36 weeks. |
| Sofosbuvir 400 mg (Genotype 1) | EXPERIMENTAL | Participants with genotype 1 HCV infection were randomized to receive sofosbuvir 400 mg (4 x 100 mg tablets)+PEG+RBV for 12 weeks followed by PEG+RBV for up to an additional 36 weeks. |
| Placebo (Genotype 1) | ACTIVE_COMPARATOR | Participants with genotype 1 HCV infection were randomized to receive placebo to match sofosbuvir (4 tablets)+PEG+RBV for 12 weeks followed by PEG+RBV for up to an additional 36 weeks. |
| Sofosbuvir 400 mg (Genotype 2/3) | EXPERIMENTAL | Participants with genotype 2 or 3 HCV infection received sofosbuvir 400 mg (4 x 100 mg tablets)+PEG+RBV for 12 weeks. |
| Sofosbuvir 100 mg+PEG+RBV | EXPERIMENTAL | Participants received sofosbuvir 100 mg (1 x 100 mg tablet) and placebo to match sofosbuvir (3 tablets) for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48) |
| Sofosbuvir 200 mg+PEG+RBV | EXPERIMENTAL | Participants received sofosbuvir 200 mg (2 x 100 mg tablets) and placebo to match sofosbuvir (2 tablets) for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48) |
| Sofosbuvir 400 mg+PEG+RBV | EXPERIMENTAL | Participants received sofosbuvir 400 mg (4 x 100 mg tablets) for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48) |
| Placebo+PEG+RBV | ACTIVE_COMPARATOR | Participants received placebo to match sofosbuvir (4 tablets) for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48) |
| Name | Type | Description |
|---|---|---|
| Sofosbuvir | DRUG | 400 mg tablet administered orally once daily |
| RBV | DRUG | 200 mg 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 | DRUG | Pegylated interferon alfa-2a (Peg-IFNα-2a) 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week |
| Sofosbuvir and Velpatasvir | DRUG | All subjects will receive one film-coated tablet of sofosbuvir/velpatasvir (400/100 mg) orally once daily for 8 weeks. |
| Ledipasvir 90 MG / Sofosbuvir 400 MG Oral Tablet [Harvoni] | DRUG | 1 pill once daily for 12 weeks for Group A |
| Sofosbuvir 400 MG [Sovaldi] | DRUG | 1 pill once daily for 12 weeks for Group C |
| Ledipasvir 90 MG | DRUG | 1 pill once daily for 12 weeks for Group D |
| Ribavirin | DRUG | Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg) |
| GS-0938 | DRUG | GS-0938 300 mg (3 × 100 mg tablets) administered orally once daily |
| Placebo to match sofosbuvir | DRUG | Placebo to match sofosbuvir administered orally once daily |
| Placebo to match GS-0938 | DRUG | Placebo to match GS-0938 administered orally once daily |
| Placebo | DRUG | Placebo to match sofosbuvir administered orally once daily |
Inclusion Criteria: * HCV RNA ≥10\^4 IU/mL at screening * Confirmed chronic HCV genotype 1 or 3 infection * HCV treatment naive * Approximately 30% of individuals may have compensated cirrhosis at screening Exclusion Criteria: * Any other chronic liver disease * Infection with hepatitis B virus (...
Sofosbuvir is an investigational small molecule being developed for the treatment of chronic Hepatitis C virus (HCV) infection, including genotypes 1, 3, 4, 5, and 6, as well as Hepatitis B. It is studied in combination with other antiviral agents such as ribavirin and pegylated interferon.
Sofosbuvir is a nucleotide analog inhibitor of the HCV NS5B RNA-dependent RNA polymerase, which is essential for viral replication. By targeting this enzyme, sofosbuvir interferes with the Hepatitis C virus's ability to multiply, thereby reducing viral load in infected patients.
Sofosbuvir is developed by Gilead Sciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol GILD. Gilead is responsible for the clinical development and regulatory strategy for this compound across multiple Hepatitis C indications.
Sofosbuvir is in Phase 3 clinical development for chronic Hepatitis C virus infection. It has completed five clinical trials, including Phase 2 and Phase 3 studies, with a total enrollment of 825 participants. Sofosbuvir is not yet approved and remains an investigational drug.
Sofosbuvir has completed several clinical trials, including NCT01329978, a Phase 2 study in HCV genotypes 1, 4, 5, and 6; NCT01435044, a Phase 2 safety study; NCT02021643, a Phase 3 trial in chronic HCV; and NCT02074514, a Phase 3 study in treatment-naive adults with genotype 1 or 3 HCV.
Sofosbuvir is the generic name for the drug also known as Sovaldi, which is a brand name used by Gilead Sciences. In clinical trials and regulatory documents, the compound is referred to as sofosbuvir, while Sovaldi is the commercial name under which it is marketed.