Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ACH-0141625
Sovaprevir · 2 trials · 2 indications
Incidence of SVR4 after the completion of dosing, reported as hepatitis C virus (HCV) ribonucleic acid less than the lower limit of quantification, in participants who received active treatment (sovaprevir and ACH-0143102 in combination with RBV) as compared to those who received placebo.
To determine the safety and tolerability of 12 weeks of sovaprevir/ACH-0143102/RBV treatment in participants with chronic genotype-1 (GT-1) HCV, the following criteria will be used: the number of participants with discontinuations due to adverse events (AEs), treatment-emergent Grade 3/Grade 4 (G3/G4) AEs, treatment-emergent G3/G4 laboratory abnormalities, and clinically significant electrocardiograms (ECGs).
Segment 1: Percentage of participants with the following: adverse events, abnormal laboratory safety tests, dose reductions, interruptions, and discontinuations. Criteria for abnormal laboratory safety tests: treatment-emergent worsening Division of AIDS (Acquired Immunodeficiency Syndrome) (DAIDs) graded laboratory tests. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
The primary efficacy endpoint for Segment 1 of the study was the percentage of participants in each treatment group achieving RVR4 (hepatitis C virus \[HCV\] ribonucleic acid (RNA) less than or equal to the limit of quantitation \[LOQ\] at the Week 4 visit).
Segment 2: Percentage of participants with the following: adverse events, abnormal laboratory safety tests and dose reductions, interruptions and discontinuations. Criteria for abnormal laboratory safety tests: treatment-emergent worsening DAIDs graded laboratory tests. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
The primary efficacy endpoint for Segment 2 of the study was the percentage of participants achieving cEVR, defined as undetectable HCV RNA at Week 12.
| Arm | Type | Description |
|---|---|---|
| Sovaprevir 200 milligrams (mg), ACH-3102 150/50 mg, RBV 1000-1200 mg | ACTIVE_COMPARATOR | Sovaprevir 200 mg once daily (qd) + ACH-3102 150 mg loading dose on Day 1, followed by 50 mg qd + RBV weight-based 1000-1200 mg qd for 12 weeks. |
| Sovaprevir 400 mg, ACH-3102 150/50 mg, RBV 1000 -1200 mg | ACTIVE_COMPARATOR | Sovaprevir 400 mg qd + ACH-3102 150 mg loading dose on Day 1, followed by 50 mg qd + RBV weight-based 1000-1200 mg qd for 12 weeks. |
| Placebo | PLACEBO_COMPARATOR | Placebo for sovaprevir capsule qd + placebo for ACH-3102 150 mg loading dose on Day 1, followed by placebo for 50 mg qd + placebo for weight-based RBV qd for 12 weeks. |
| Segment 1: 200 milligrams (mg) ACH-0141625 | EXPERIMENTAL | 200 mg ACH-0141625 for 28 days plus pegylated interferon (Peg-IFN) alpha-2a and ribavirin (RBV) for 48 weeks |
| Segment 1: 400 mg ACH-0141625 | EXPERIMENTAL | 400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks |
| Segment 1: 800 mg ACH-0141625 | EXPERIMENTAL | 800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks |
| Segment 1: Placebo | PLACEBO_COMPARATOR | Placebo for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks |
| Segment 2: 200 mg ACH-0141625 | EXPERIMENTAL | 200 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks |
| Segment 2 : 400 mg ACH-0141625 | EXPERIMENTAL | 400 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks |
| Segment 2 : 800 mg ACH-0141625 | EXPERIMENTAL | 800 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks |
| Name | Type | Description |
|---|---|---|
| Sovaprevir | DRUG | Nonstructural protein 3/4A protease inhibitor. |
| ACH-3102 | DRUG | Nonstructural protein 5A inhibitor. |
| Ribavirin | DRUG | - |
| Placebo | DRUG | - |
| ACH-0141625 (Sovaprevir) | DRUG | 200 mg oral capsule once daily |
| Pegylated Interferon alpha-2a | DRUG | 180 micrograms (ug) once a week by subcutaneous injection |
Inclusion Criteria: * Chronic HCV infection. * HCV GT-1. * HCV ribonucleic acid \> 10,000 international units/milliliter at screening. * Female participants must be willing to use 2 effective methods of contraception, one of which must be a barrier method, during the dosing period and 6 months afte...
Sovaprevir is an investigational small molecule being developed for the treatment of chronic Hepatitis C. It was studied in a Phase 2 clinical trial in treatment-naive patients with genotype-1 Hepatitis C virus. The drug is not approved and remains in clinical development.
Sovaprevir is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the stock exchange under the ticker symbol AZN. The company is conducting clinical research on this investigational drug for chronic Hepatitis C.
Sovaprevir is in Phase 2 clinical development. It has completed one Phase 2 trial, which was a randomized, double-blind, placebo-controlled study. The drug is investigational and has not been approved by regulatory authorities.
Sovaprevir has one completed clinical trial registered as NCT01849562. This Phase 2 study evaluated the safety, tolerability, and efficacy of 12 weeks of Sovaprevir combined with ACH-3102 and ribavirin in 30 treatment-naive participants with genotype-1 chronic Hepatitis C.
No, Sovaprevir is not the same as ACH-3102. In the clinical trial NCT01849562, Sovaprevir was studied in combination with ACH-3102 and ribavirin. Sovaprevir is a separate investigational drug being developed by AstraZeneca for chronic Hepatitis C.