What is elvucitabine?
- Elvucitabine is an anti-HIV medication. It is in a category of HIV medicines called nucleoside reverse transcriptase inhibitors (NRTIs). Elvucitabine prevents HIV from entering the nucleus of healthy T-cells. This prevents the cells from producing new virus and decreases the amount of virus in the body.
- Elvucitabine is being developed by Achillion Pharmaceuticals. It has not yet been reviewed by the U.S. Food and Drug Administration.
What is already known about elvucitabine?
- The necessary dose of elvucitabine has not yet been determined. However, early research suggests that it will only need to be taken once a day.
- Like other nucleoside reverse transcriptase inhibitors (NRTIs), elvucitabine might interact with other medications, including those used to treat HIV. It is important that your personal physician and/or the research nurse or study investigator be aware of all drugs you are taking, including those you buy without a prescription.
- According to test tube studies, elvucitabine may be active against strains of the virus already resistant to other NRTIs, including Retrovir (zidovudine) and Epivir (lamivudine).
- Elvucitabine will likely be studied and used in combination with other drugs, including another NRTI and at least one protease inhibitor (PI) or non-nucleoside reverse transcriptase inhibitor (NNRTI).
- Elvucitabine also appears to be active against the hepatitis B virus (HBV) and is currently being studied as a possible treatment for chronic hepatitis B.
What has been learned from clinical trials?
- In one early study, 10mg elvucitabine was used without other HIV drugs for seven days by HIV-positive people with little previous treatment experience. At day 7, viral load decreased by an average of 0.85 log in the elvucitabine group, compared with virtually no change in the placebo group.
- The developer is conducting a phase II study, comparing 10mg elvucitabine to Epivir (lamivudine), combining both drugs with Sustiva (efavirenz) and Viread (tenofovir). During the first 12 weeks of the study, patients don't know whether they're taking elvucitabine or Epivir. After that, patients responding well to either treatment combination will be told which medication they are receiving and continue on their regimen for another 84 weeks.
The initial 12-week results have been reported by Achillion. In the elvucitabine group, viral loads were reduced, on average, by 2.7 log. In the Epivir group, viral loads decreased by an average of 3 log after 12 weeks. Additional data from this study will be reported.
- A second phase II study, evaluating elvucitabine in HIV-positive people infected with HIV strains resistant to Epivir or Emtriva (emtricitabine)—virus harboring the M184 mutation in its reverse transcriptase enzyme—is expected to be completed at the end of 2007, with results announced in early 2008.
What is known about side effects?
- Because elvucitabine has a different chemical structure than other NRTIs, researchers suggest that it will be less likely to damage mitochondria, the "powerhouses" inside human cells. This may translate into fewer side effects typically associated with NRTIs and mitochondrial damage, including peripheral neuropathy and lipoatrophy.
- Elvucitabine was "well tolerated, with no serious drug-related adverse events," according to the 12-week study results reported thus far.
Who should not take elvucitabine?
- It is not known whether elvucitabine will harm an unborn baby. It is very important to treat HIV/AIDS during pregnancy to reduce the risk of infecting your baby. Talk to your doctor about your treatment options.
- It is not known whether elvucitabine passes into breast milk and what effect it may have on a nursing baby. To prevent transmission of the virus to uninfected babies, it is recommended that HIV-positive mothers not breast-feed.
Where can I learn more about clinical trials of elvucitabine?
- If you would like to find out if you are eligible for any clinical trials that include elvucitabine, there is an interactive web site run by ACRIA, the AIDS Community Research Initiative of America.
- Another useful service for finding clinical trials is AIDSinfo.nih.gov, a site run by the U.S. National Institutes of Health. They have "health information specialists" you can talk to at their toll-free number at 1-800-HIV-0440 (1-800-448-0440).