Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ACH-0141625 (Sovaprevir), Sovaprevir
ACH-0141625 · 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...
Top 1 of 4 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Atea Pharmaceuticals, Inc. | AVIR | 2 | PHASE3 | Bemnifosbuvir-Ruzasvir |
ACH-0141625 is an investigational small molecule developed for the treatment of hepatitis C, a viral infection of the liver. It was studied in combination with peginterferon and ribavirin in HCV positive participants. It is not an approved therapy and remains in clinical development.
ACH-0141625 is being developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca is the sponsor of the clinical program evaluating the compound in hepatitis C.
ACH-0141625 has completed a Phase 2 clinical trial in hepatitis C. The program has one completed Phase 2 study and no active trials. The drug is investigational and has not been approved for any indication.
ACH-0141625 was evaluated in one completed Phase 2 trial, NCT01180790, titled Safety, Tolerability, and Antiviral Activity of ACH-0141625 or Placebo in Combination With Peginterferon and Ribavirin in Hepatitis C Virus (HCV) Positive Participants. The randomized, double-blind, placebo-controlled study enrolled 122 participants across the United States and Belgium.
Yes, ACH-0141625 is also known as sovaprevir. Both names refer to the same investigational small molecule developed by AstraZeneca for hepatitis C, so searches for sovaprevir and ACH-0141625 describe the same drug asset.