|What is elvitegravir?
- Elvitegravir is an integrase inhibitor by Gilead Sciences. It is a component of the approved fixed-dose combination tablet Stribild and is currently being reviewed by the U.S. Food and Drug Administration for possible approval as a stand-alone antiretroviral for use in combination with other HIV drugs.
- After HIV's genetic material is deposited inside a cell, its RNA must be converted (reverse transcribed) into DNA. A viral enzyme called integrase then helps to hide HIV's DNA inside the cell's DNA. Once this happens, the cell can begin producing genetic material for new viruses. Integrase inhibitors, such as elvitegravir, are designed to block the activity of the integrase enzyme and to prevent HIV DNA from entering healthy cell DNA.
- Elvitegravir will need to be used in combination with other drugs. Clinical trials continue to evaluate its effect in combination with other drugs, including those currently approved for the treatment of HIV.
What is already known about elvitegravir?
- The elvitegravir doses being explored in clinical trials are 85 mg or 150 mg once daily, combined with 100mg Norvir (ritonavir) or Gilead's experimental pharmacokinetics enhancer cobicistat. Norvir or cobicistat is used to boost elvitegravir in the bloodstream, making it more effective against HIV.
- Elvitegravir, especially when combined with Norvir or cobicistat, 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.
- Elvitegravir holds promise for HIV-positive patients who have taken other HIV drugs in the past. Because elvitegravir targets HIV differently than most available drugs, chances are that many people living with the virus—notably those who haven't used another integrase inhibitor (e.g., Isentress)—will likely benefit from using elvitegravir.
- A major Phase III clinical trial is comparing Norvir-boosted elvitegravir to Isentress in people living with HIV who have used other antiretrovirals in the past. Forty eight-week data from the clinical trial (Study 145) were reported at the 6th IAS Conference on HIV Pathogenesis, Treatment and Prevention in Rome. In summary, the results demonstrated that elvitegravir works just as well as Isentress in treatment-experienced patients, when both drugs are combined with a boosted protease inhibitor and a third antiretroviral.
What about drug interactions?
- Studies on potential interactions between elvitegravir and other drugs have not yet been reported, but are planned and ongoing.
What is known about side effects?
- According to clinical trial results reported to date, the most common side effects associated with therapy that includes elvitegravir include nausea and diarrhea, upper respiratory tract infections and broncitis, back and joint pain and urinary tract infections. While elvitegravir appears more likely to be associated with diarrhea than Isentress, it appears less likely to cause liver enzyme increases than Isentress.
Who should not take elvitegravir?
- It is not known whether elvitegravir 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 elvitegravir 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 elvitegravir?
- If you would like to find out if you are eligible for any clinical trials that include elvitegravir, visit ClinicalTrials.gov, a site run by the U.S. National Institutes of Health. The site has information about all HIV-related clinical studies in the United States. For more info, you can call their toll-free number at 1-800-HIV-0440 (1-800-448-0440) or email firstname.lastname@example.org.