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What is Reverset?
- Reverset is an anti-HIV medication. It is in a category of HIV medicines called nucleoside reverse transcriptase inhibitors (NRTIs). Reverset 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.
- Reverset is being co-developed by Pharmasset and Incyte. It has not yet been reviewed by the U.S. Food and Drug Administration.
- In early April 2006, the co-developers of Reverset announced that they were discontinuing development of the drug. At the dose considered to be maximally effective against HIV, cases of significantly elevated amylase levels (hyperlipasemia) – a sign of possible pancreas damage – were reported in several study volunteers. Because of this finding, along with the fact that lower (and potentially safer) doses of the drug are not effective against HIV, development of Reverset was discontinued.
What is already known about Reverset?
- The necessary dose of Reverset has not yet been determined. Reverset will most likely only need to be taken once a day.
- Test tube studies suggest that Reverset is active against HIV strains containing mutations that result in resistance to other NRTIs.
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 Like other nucleoside reverse transcriptase inhibitors (NRTIs), Reverset 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.
What has been learned from clinical trials?
- A phase II clinical trial (Study 202), in which 30 HIV-positive people took Reverset (without other anti-HIV drugs) for ten days has been completed. The doses tested were 50mg, 100mg, and 200mg once a day. After ten days of treatment, significant reductions in viral load were seen in all of the patients and all doses were well tolerated. A test tube experiment in this study demonstrated that the 200mg Reverset dose produces high enough drug levels in the bloodstream to successfully suppress virus resistant to Retrovir® (AZT), Zerit® (d4T), Epivir® (3TC), or Viread® (tenofovir).
- A phase IIb clinical trial (Study 203) is currently being conducted. Preliminary data from the study were reported in July 2005. The study has enrolled 199 HIV-positive people, all of whom had been on other anti-HIV drugs in the past and had a viral load of at least 2,000 upon entering the study (while on an anti-HIV drug regimen). For the first two weeks, the study volunteers added one of three Reverset doses (50mg, 100mg, or 200mg once daily) or placebo to their failing drug regimen. After two weeks, the study volunteers remained on either Reverset or placebo but were permitted to change any of their other drugs, based on drug-resistance testing (to "optimize" their treatment), for an additional 14 weeks. Sixteen weeks after entering the study, study volunteers in the placebo group were allowed to switch to Reverset.
After the first two weeks, viral loads dropped by 0.3 logs in the 100mg Reverset group, 0.4 logs in the 50mg Reverset group, and 0.7 logs in the 200mg Reverset group (compared to 0.03 logs in the placebo group). After 16 weeks of Reverset, 54% in the 200mg Reverset group had experienced a 1 log (or greater) reduction in viral load, compared to 40% of those in the placebo group, 38% of those in the 50mg Reverset group, and 31% of those in the 100mg Reverset group.
- A small study involving eight HIV-positive people who had tried and failed other NRTIs in the past found that, by adding Reverset to a failing regimen, 200mg of the drug for ten days reduced viral load by 0.8 log.
- Because there were only small viral load differences between patients receiving Reverset and placebo for 16 weeks in Study 203, the FDA has requested that the manufacturer complete another phase II study before moving forward.
What is known about side effects?
- Very little is known about the possible side effects of Reverset. In the phase II clinical trial completed, the most common side effects were cold symptoms, headache, and fatigue.
- Four cases of pancreatitis were seen in patients receiving Reverset in Study 203 (all taking the 100mg dose). It is not clear if the pancreatitis was caused by the Reverset or the other anti-HIV drugs being used.
Who should not take Reverset?
- It is not known whether Reverset 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.
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 It is not known whether Reverset 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 Reverset?
- If you would like to find out if you are eligible for any clinical trials that include Reverset, 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).
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