Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Sofosbuvir · 1 trial · 1 indication
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ; 15 IU/mL) 12 weeks after the last dose of study drug.
| Arm | Type | Description |
|---|---|---|
| Glecaprevir/Pibrentasvir + SOF + RBV for 12 weeks | EXPERIMENTAL | Participants without cirrhosis who had non-genotype 3 infection and were naïve to protease inhibitor (PI) and/or nonstructural viral protein 5A inhibitor (NS5Ai) prior to participation in AbbVie HCV parent study received daily treatment with glecaprevir/pibrentasvir (GLE/PIB) 300 mg/120 mg plus sofosbuvir (SOF) 400 mg plus twice-daily weight-based ribavirin (RBV) 600 mg - 1200 mg daily total for 12 weeks. |
| Glecaprevir/Pibrentasvir + SOF + RBV for 16 weeks | EXPERIMENTAL | Participants with genotype 3, and/or compensated cirrhosis, and/or experience with PI and/or NS5Ai prior to participation in Abbvie HCV parent study received daily treatment with GLE/PIB 300 mg/120 mg plus SOF 400 mg plus twice-daily weight-based RBV 600 mg - 1200 mg daily total for 16 weeks. |
| Name | Type | Description |
|---|---|---|
| Sofosbuvir | DRUG | Tablet for oral administration |
| Glecaprevir/Pibrentasvir | DRUG | Coformulated tablet for oral administration |
| Ribavirin | DRUG | Tablet for oral administration |
Inclusion Criteria: * Male or female subjects must be adults (18 years of age or older) or adolescents (12 to less than 18 years of age weighing at least 35 kg). * Subject must have experienced virologic failure during or after treatment with ABT-493/ABT-530 in an AbbVie HCV parent study. Subjects ...
Sofosbuvir is used for the treatment of Hepatitis C Virus Infection. It is a small molecule being developed by AbbVie Inc. for this infectious disease indication. In clinical research, it has been studied in combination with other antiviral agents for patients who did not respond to previous treatment.
Sofosbuvir is developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. AbbVie is conducting clinical development of Sofosbuvir for Hepatitis C Virus Infection.
Sofosbuvir is in Phase 3 clinical development. It is an investigational drug for Hepatitis C Virus Infection and has not been reported as approved. The Phase 3 trial involving Sofosbuvir has been completed.
Sofosbuvir was studied in a Phase 3 clinical trial registered as NCT02939989. This completed trial evaluated the efficacy and safety of Glecaprevir/Pibrentasvir in combination with Sofosbuvir and Ribavirin in participants with Hepatitis C Virus who did not respond to a previous AbbVie study.
No, Sofosbuvir is not the same as Glecaprevir. Sofosbuvir is a separate antiviral agent that was studied in combination with Glecaprevir and Pibrentasvir, along with Ribavirin, in a clinical trial for Hepatitis C Virus Infection. Each drug has a distinct role in the combination regimen.