Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Elvucitabine · 4 trials · 2 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 |
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 ...
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Elvucitabine is an investigational small molecule being developed for the treatment of HIV infections, including Human Immunodeficiency Virus (HIV)-1 infection. It is being studied in patients with documented M184V mutation and in treatment-naive HIV-1 infected participants, among other populations.
Elvucitabine is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The drug is currently in Phase 2 clinical development for the treatment of HIV infections.
Elvucitabine is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials have been completed, including a Phase 2 study comparing Elvucitabine to lamivudine in HIV-1 infected, treatment-naive participants.
Elvucitabine has been studied in several completed clinical trials. These include NCT00312039, a Phase 1 study of once daily Elvucitabine versus lamivudine in participants with a documented M184V mutation, and NCT00350272, a Phase 2 study of Elvucitabine/efavirenz/tenofovir versus lamivudine/efavirenz/tenofovir in treatment-naive HIV-1 infected participants.
No, Elvucitabine is not the same as lamivudine. In clinical trials, Elvucitabine has been compared directly against lamivudine. For example, one study evaluated once daily Elvucitabine versus lamivudine in participants with a documented M184V mutation, and another compared Elvucitabine/efavirenz/tenofovir to lamivudine/efavirenz/tenofovir.