Antiretroviral combination tablet approved for treatment of HIV-1

FDA has approved the antiretroviral Prezcobix (darunavir 800 mg/cobicistat 150 mg, Janssen Therapeutics) for the treatment of human immunodeficiency virus 1 (HIV-1). The once-daily, fixed-dose tablet is a combination of an HIV-1 protease inhibitor, darunavir, and a CYP3A4 inhibitor, cobicistat, the latter of which serves as a “boosting” agent.

The new agent is to be used for treatment-naïve and treatment-experienced adults with HIV-1 with no darunavir resistance-associated substitutions. Darunavir/cobicistat is to be taken orally in combination with other HIV-1 medications and with food. Importantly, it can also help reduce the number of pills required in an overall combination antiretroviral treatment regimen.

FDA drug approvals

Bioequivalence data on the use of the combination tablet versus single agents, as well as a clinical study evaluating the safety and efficacy of cobicistat-boosted darunavir for the treatment of adults with HIV-1 with no darunavir resistance-associated mutations, served as the basis for FDA approval.

Clinical trials of darunavir co-administered with ritonavir demonstrated the combination agent’s efficacy, as also did pharmacokinetic trials of darunavir boosted with cobicistat versus darunavir boosted with ritonavir. The once-daily use of darunavir co-administered with ritonavir was further evaluated in 2 phase 3 studies in the darunavir clinical development program.

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It has not been established whether darunavir/cobicistat is safe and effective in those with HIV infection who are younger than age 18 years.

The need for the availability of a broad range of antiretroviral agents continues to be important, not only due to the continuing problem of HIV infection but also due to the fact that patients taking these drugs can become resistant to them over time.

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It is estimated that 1.2 million individuals live with HIV in the United States today, with about 50,000 US residents being diagnosed with HIV annually. That figure, for a disease first reported in 1981, has not declined in almost 2 decades.