Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ACH-0141625 · 1 trial · 1 indication
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 |
|---|---|---|
| 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 |
|---|---|---|
| ACH-0141625 (Sovaprevir) | DRUG | 200 mg oral capsule once daily |
| Placebo | DRUG | Powder in capsule once daily |
| Pegylated Interferon alpha-2a | DRUG | 180 micrograms (ug) once a week by subcutaneous injection |
| Ribavirin | DRUG | 400 mg or 600 mg (morning \[AM\]) and 600 mg (evening \[PM\]) capsules taken orally twice daily |
Inclusion Criteria: * Males and females, aged 18 years and older * Chronic hepatitis C genotype 1 (as specified in the protocol) * Treatment naive * Females who are post-menopausal and amenorrheic must have a follicle-stimulating hormone (FSH) at screening. Females of childbearing potential must ha...
| 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 |
ACH-0141625 is an investigational small molecule being studied for the treatment of Hepatitis C. It is being developed as an add-on therapy to peginterferon and ribavirin for HCV positive participants. The drug is currently in Phase 2 clinical development and is not yet approved.
ACH-0141625 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The drug is an investigational small molecule in Phase 2 clinical development for Hepatitis C.
ACH-0141625 is in Phase 2 clinical development. It is an investigational small molecule being studied for the treatment of Hepatitis C. The drug is not yet approved and is still undergoing clinical trials to evaluate its safety and antiviral activity.
ACH-0141625 has been studied in one completed Phase 2 clinical trial, registered as NCT01180790. This trial evaluated the safety, tolerability, and antiviral activity of ACH-0141625 or placebo in combination with peginterferon and ribavirin in Hepatitis C virus positive participants. The trial enrolled 122 participants in the United States and Belgium.
Yes, ACH-0141625 has been studied in a randomized, double-blind, placebo-controlled Phase 2 clinical trial. In this trial, participants received either ACH-0141625 or a placebo, both in combination with peginterferon and ribavirin, to assess the drug's safety and antiviral activity in Hepatitis C patients.