New HIV Drug Holds Promise

A New Treatment for HIV-1 Patients: A Q&A with Karen Tashima, MD

Karen Tashima    MDThe U.S. Food and Drug Administration recently approved Prezcobix, a fixed-dose HIV-1 protease inhibitor combined with a CYP3A4 inhibitor. Karen Tashima, MD, director of HIV Clinical Studies at The Miriam Hospital, was a lead investigator in the clinical study that evaluated the safety and efficacy of cobicistat-boosted darunavir for treatment of HIV-1 in adults with no darunavir resistance-associated mutations. Here she talks about the importance of FDA approval of the combination pill and how it helps to reduce the number of pills in a patient's overall treatment regimen.

Q: What did you study in this clinical trial?
A: We studied the safety and efficacy of a combination of medications for HIV infection, cobicistat and darunavir, with two other active medications for HIV treatment in a study called GS-US-216-0130. The protease inhibitor darunavir has to be given with a pharmacokinetic enhancer or boosting agent, in this case cobicistat. At The Miriam Hospital’s Immunology Center HIV Clinical Trials Unit, my staff and I recruited and followed eight study participants. We were one of 56 sites across the U.S., and I was asked to review and approve the data for the overall study of 313 patients. Based on the results of this study, the FDA approved a combination pill, putting both of these medications into one pill.

Q: Why was this trial conducted?
A: The study was conducted to show that the combination of cobicistat-boosted darunavir and two other active medications was safe and efficacious in HIV-infected patients whose virus had no darunavir resistance-associated substitutions. Adverse reactions did not differ substantially from those reported in clinical trials using another boosting agent with darunavir. With FDA approval of the combination pill Prezcobix (darunavir 800mg/cobicistat 150mg), HIV providers can now prescribe the medication to patients.

Q: How will the availability of these new medications impact patients with HIV?
A: The two medications in this study have been combined into one pill, reducing the number of pills a patient has to take. Human Immunodeficiency Virus therapy always consists of three medications, so the more they can be combined, the more convenient the therapy is for patients. HIV therapy is so effective in reducing illness and death from HIV infection that we want to make it easier for patients to have these benefits. In addition, treating patients effectively has been shown to decrease the risk of HIV transmission, so the benefits can extend to public health as well.

For more information about HIV primary and specialty care at the AIDS/HIV Immunology Center at The Miriam Hospital or call 401-793-2928.