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What is the most important information I should know about rilpivirine?
Rilpivirine is an experimental non-nucleoside reverse transcriptase inhibitor (NNRTI) being developed by Tibotec, a biotechnology company in Belgium. It has not yet been evaluated by the U.S. Food and Drug Administration (FDA) for use by people living with HIV.
What is rilpivirine?
Rilpivirine is in a category of HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs). Rilpivirine 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.
The correct dose for rilpivirine has not yet been determined. Preliminary experiments suggest that the drug can be taken by mouth once a day.
Like other NNRTIs, rilpivirine 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.
It is expected that rilpivirine, when combined with two NRTIs, will have strong activity against HIV in people who have never taken an NNRTI in the past.
It is not yet known if rilpivirine will work against strains of HIV that are already resistant to currently available NNRTIs. All of the currently marketed NNRTIs are highly cross-resistant to each other. Test tube data suggest that rilpivirine might be effective against strains of HIV that are at least partly resistant to any of the approved drugs. But this cannot be determined until information from clinical trials is made available.
What has been learned from clinical trials?
Rilpivirine is being studied in clinical trials involving HIV-positive people who are new to anti-HIV treatment and HIV-positive people who have tried and failed other NNRTIs in the past.
In one clinical trial, 47 HIV-positive patients who had not taken any other drugs in the past were given a daily dose of liquid rilpivirine (25mg, 50mg, 100mg, 150mg, or placebo). The patients who received rilpivirine saw their HIV viral load decrease by approximately 1.2 log after seven days of treatment, regardless of the dose given. No resistance mutations were detected in any of the patients after the seven days of treatment.
There is also a 96-week study comparing three once-daily doses of rilpivirine to Sustiva® (efavirenz), all in combination with Truvada® (tenofovir plus emtricitabine) or Combivir® (zidovudine plus lamivudine). Ninety-three patients have been randomized to the 25mg rilpivirine group, 95 to the 75mg group, 91 to the 150mg, and 89 to Sustiva. All patients enrolled into the study were treatment-naïve, meaning that they had not taken any other HIV medications in the past.
After 48 weeks of treatment, viral loads below 50 copies – undetectable – were documented in 81% of those in the 25mg group, 80% of those in the 75mg group, and 77% in the 125mg group. These data were comparable to the 81% undetectable rate in the Sustiva group. CD4 count changes did not differ significantly between the groups; average increases of 125 to 145 cells after 48 weeks of treatment were reported. While rilpivirine had comparable efficacy to Sustiva, it did not carry the same risk of central nervous system side effects typically seen in Sustiva-treated patients.
What is known about side effects?
Among the rilpivirine-treated patients in the 96-week study discussed above, approximately 20% of patients experienced nausea, compared to 18% of those in the Sustiva group. Central nervous system effects – such as dizziness, somnolence, and vertigo – were significantly more common in the Sustiva group (53%) compared to the rilpivirine groups (33%). Rash was also less likely to occur among those taking any dose of rilpivirine (8%) compared to those receiving Sustiva (19%).
Who should not take rilpivirine?
It is not known whether rilpivirine 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 rilpivirine 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 rilpivirine?
If you would like to find out if you are eligible for any clinical trials that include rilpivirine, 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).
Last Revised: March 15, 2007
This content is written by the editorial team at AIDSmeds.com.
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rilpivirine
belongs to a class of anti-HIV drugs called 
Check My Meds
Like other NNRTIs, rilpivirine 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.
It is not known whether rilpivirine 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 rilpivirine 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.