Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as beta-L-Fd4C, Elvucitabine
ACH-126,443 · 5 trials · 3 indications
The proportion of participants having achieved a virologic response for elvucitabine 10 mg/day in combination with efavirenz and tenofovir in HIV-1-infected participants over 12 weeks compared with the proportion of participants having achieved a virologic response for lamivudine 300 mg/day in combination with efavirenz and tenofovir. Virologic response was defined as having achieved undetectable (\<50 copies/mL) HIV-1 RNA levels from baseline assessment.
Determination of the safety profile of elvucitabine as defined by the frequency, type and severity of treatment-emergent adverse events (AEs) and the frequency of Grade 3 and Grade 4 laboratory abnormalities.
| Arm | Type | Description |
|---|---|---|
| Elvucitabine | EXPERIMENTAL | Participants currently receiving elvucitabine will continue elvucitabine as part of their antiretroviral therapy (ART) regimen for an additional 48 months. |
| Elvucitabine, Efavirenz, Tenofovir | EXPERIMENTAL | Elvucitabine (blinded) 10 milligrams (mg)/day in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible participants continued with an additional 84 weeks of open-label treatment (through Week 96). Participants who experienced at least a 2 log10 decrease in HIV-1 RNA from Baseline or who had an HIV-1 RNA level of less than 400 copies/ mL at Week 10 and had not experienced any Grade 3 or 4 hematological toxicity as of the Week 10 measurement were considered eligible for an additional 84 weeks of open-label treatment after Week 12. |
| Lamivudine, Efavirenz, Tenofovir | ACTIVE_COMPARATOR | Lamivudine (blinded) 300 mg daily in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible participants continued with an additional 84 weeks of open-label treatment (through Week 96). Participants who experienced at least a 2 log10 decrease in HIV-1 RNA from Baseline or who had an HIV-1 RNA level of less than 400 copies/mL at Week 10 and had not experienced any Grade 3 or 4 hematological toxicity as of the Week 10 measurement were considered eligible for an additional 84 weeks of open-label treatment after Week 12. |
| A | EXPERIMENTAL | - |
| B | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Elvucitabine | DRUG | 10 milligrams (mg) elvucitabine daily as part of an ART regimen |
| Lamivudine | DRUG | - |
| Emtricitabine | DRUG | - |
| Tenofovir | DRUG | Tenofovir open-label 300 mg orally daily |
| Efavirenz | DRUG | Efavirenze open-label 600 mg orally daily |
| ACH-126,443 | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: • Participants must have successfully completed 96 weeks of elvucitabine therapy in Protocol ACH443-015 or participants have completed 48 weeks of elvucitabine therapy in Protocol ACH443-014A-018 . Exclusion Criteria: * Participant has experienced virologic rebound as defined ...
ACH-126,443 is an investigational small molecule being studied for the treatment of chronic hepatitis B. It was evaluated in a Phase 2 clinical trial in treatment-naive adults with chronic hepatitis B virus infection. The drug is not approved and remains in clinical development.
ACH-126,443 is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the stock exchange under the ticker AZN. The company conducted a Phase 2 clinical trial of the drug in patients with chronic hepatitis B.
ACH-126,443 is in Phase 2 clinical development. A Phase 2 study of the drug has been completed, but it is not approved and is still investigational. The completed trial enrolled 79 participants with chronic hepatitis B.
ACH-126,443 has one completed clinical trial, registered as NCT00034359. This Phase 2 study assessed the safety and antiviral activity of ACH-126,443 in treatment-naive adults with chronic hepatitis B virus infection. The trial enrolled 79 participants and was conducted in Bulgaria and the Federal Republic of Yugoslavia.
ACH-126,443 is also known as beta-L-Fd4C. The clinical trial NCT00034359 evaluated ACH-126,443 (beta-L-Fd4C) in patients with chronic hepatitis B. Both names refer to the same investigational drug.