Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Sofosbuvir · 1 trial · 1 indication
Hepatitis C Virus ribonucleic acid (HCV-RNA) levels in plasma were measured using the Roche COBAS®AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 on blood samples drawn from each participant. SVR12 was defined as HCV RNA below the lower limit of quantification (\<LLOQ) at 12 weeks after the end of all study therapy. The primary efficacy hypothesis for this study was that the percentage of participants achieving SVR12 in the grazoprevir plus elbasvir arm was non-inferior to the percentage in the SOF plus PR arm. A secondary statistical analysis was performed to determine whether the percentage of participants achieving SVR12 in the grazoprevir plus elbasvir arm was superior to the percentage in the SOF plus PR arm.
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the use of the Sponsor's product, was also an AE. The percentage of participants who experienced at least one AE was reported for each treatment arm.
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the use of the Sponsor's product, was also an AE. The percentage of participants who discontinued study treatment due to an AE was reported for each treatment arm. Participants that discontinued study drug treatment due to an AE may have still continued on trial.
| Arm | Type | Description |
|---|---|---|
| Grazoprevir + Elbasvir | EXPERIMENTAL | Participants receive a fixed-dose combination (FDC) tablet of 100 mg grazoprevir and 50 mg elbasvir for 12 weeks, followed by 24 weeks of follow-up. |
| SOF + PR | ACTIVE_COMPARATOR | Participants receive SOF (400 mg) combined with PegIntron (1.5 mcg/kg) plus RBV (1000-1200 mg weight-based dose) for 12 weeks, followed by 24 weeks of follow-up. |
| Name | Type | Description |
|---|---|---|
| Sofosbuvir | DRUG | 400 mg tablets, taken orally (PO) every day (QD) for 12 weeks. |
| PegIntron | BIOLOGICAL | PegIntron administered subcutaneously every week (QW) at 1.5 mcg/kg for 12 weeks. |
| Ribavirin | DRUG | Capsule and/or tablet administered PO twice daily (BID) based on weight (1000 - 1200 mg) for 12 weeks. |
| Grazoprevir/Elbasvir (100 mg/50 mg) FDC | DRUG | Grazoprevir/Elbasvir (100 mg/50 mg) FDC, taken PO QD for 12 weeks. |
Inclusion Criteria: * Weigh ≥40 kg and ≤125 kg * documented chronic HCV GT1, GT4, or GT6 infection * cirrhosis/absence of cirrhosis defined by liver biopsy, Fibroscan, or FibroSure® * either treatment naïve or PR Null Responder, PR Partial Responder, or PR Prior Relapser * participant and partner b...
| 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 |
Sofosbuvir is an investigational small molecule being studied for the treatment of Hepatitis C. It is currently in Phase 3 clinical development. Sofosbuvir is being evaluated in combination with other antiviral agents for Hepatitis C virus infection.
Sofosbuvir is being developed by Merck & Company, Inc., which is publicly traded under the ticker symbol MRK. The company is conducting clinical trials to evaluate the safety and efficacy of Sofosbuvir in patients with Hepatitis C.
Sofosbuvir is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 trial for Sofosbuvir has been completed, with results expected to inform further development.
Sofosbuvir has been studied in one completed Phase 3 clinical trial with the identifier NCT02358044. This trial evaluated the efficacy and safety of a combination of grazoprevir and elbasvir compared to sofosbuvir plus pegylated interferon and ribavirin in patients with Hepatitis C virus genotype 1, 4, or 6 infection.
Sofosbuvir is the generic name for the drug also known as Sovaldi. In the clinical trial data, Sofosbuvir is used as a comparator in a study evaluating the combination of grazoprevir and elbasvir for Hepatitis C treatment.