|What is apricitabine?
- Apricitabine is an experimental nucleoside reverse transcriptase inhibitor (NRTI).
- Apricitabine is being developed by Avexa, an Australian pharmaceutical company. The drug was first developed by BioChem Pharma (where it was called BCH10618). BioChem Pharma was then sold the Shire Pharmaceuticals (where the drug was called SPD754). Shire then sold the rights to develop the drug to Avexa.
- Apricitabine has not yet been evaluated or approved by the U.S. Food and Drug Administration.
- On May 10, 2010, apricitabine's developer, Avexa Limited, announced that it was suspending the apricitabine development program. While it is possible that apricitabine will be sold to another company for ongoing development, no licensing agreements have been announced.
What is already known about apricitabine?
- Apricitabine is an anti-HIV medication. It is in a category of HIV medicines called nucleoside reverse transcriptase inhibitors (NRTIs). Apricitabine prevents HIV from entering the nucleus of healthy CD4 cells. This prevents the cells from producing new virus and decreases the amount of virus in the body.
- Apricitabine will need to be used in combination with other drugs.
- Apricitabine's chemical structure is similar to that of Epivir (lamivudine) and Emtriva (emtricitabine).
- The dose being studied is 800 mg, twice daily.
- Like other NRTIs, apricitabine 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, apricitabine may be active against strains of the virus already resistant to other NRTIs, including Retrovir (AZT) and Epivir. Early clinical trial results also suggest that it is active against Epivir-resistant HIV. Test tube studies also suggest that apricitabine can cause the K65R mutation, which can cause resistance to Videx (didanosine) and Viread (tenofovir).
- Avexa announced October 2, 2009, that it is closing a planned 48-week phase III study of apricitabine early in order to analyze the data and make decisions about the drug's fate. The 24-week data from the study, potentially with details regarding the closure of the Phase III study, are due in early 2010.
What about drug interactions?
- Thus far, apricitabine has only been studied in combination with Epivir. A study has determined that Epivir can decrease the amount of apricitabine inside cells, meaning that apricitabine cannot be combined with Epivir or Emtriva.
- Other studies are being conducted or developed to further explore apricitabine's interactions with other medications used to treat HIV, HIV-related problems and other diseases.
What is known about side effects?
- The most common side effects reported so far with apricitabine were nasal congestion, chest congestion, nausea, diarrhea and modest increases in triglycerides. These side effects occurred at roughly the same rate in people taking apricitabine and those taking Epivir.
- Other studies are being conducted or developed to further explore apricitabine's side effects.
Who should not take apricitabine?
- It is not known whether apricitabine 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 apricitabine 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 apricitabine?
- If you would like to find out if you are eligible for any clinical trials that include apricitabine, 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).