Janssen Therapeutics, Division of Janssen Products, LP (Janssen), today announced the U.S. Food and Drug Administration (FDA) has approved PREZCOBIX™ (darunavir 800 mg/cobicistat 150 mg) tablets, an HIV-1 protease inhibitor combined with a CYP3A4 inhibitor, for the treatment of human immunodeficiency virus (HIV-1) in combination with other antiretroviral agents for treatment-naive and treatment-experienced adults with no darunavir resistance-associated substitutions.
PREZCOBIX™ is a once-daily, fixed-dose antiretroviral combination tablet containing 800 mg of darunavir, marketed as PREZISTA® in the United States, and 150 mg of cobicistat, a pharmacokinetic enhancer or “boosting” agent, developed and marketed as Tybost® by Gilead Sciences, Inc., taken orally with other HIV-1 medications and with food.
“Additional options remain an important medical priority to meet the diverse needs of those living with and managing this disease,” said Karen Tashima, M.D., professor of medicine in the Division of Infectious Diseases, Brown University, director of HIV Clinical Studies, Miriam Hospital, and a lead investigator in the GS-US-216-0130 study. “This approval gives physicians the option of a darunavir-based fixed-dose combination tablet to treat adults living with the HIV-1 infection, which can help reduce the number of pills in their overall treatment regimen.”
The FDA approval was based on bioequivalence data evaluating the use of a darunavir and cobicistat fixed-dose combination tablet versus single agents (TMC114IFD1003) and a clinical study evaluating the safety and efficacy of cobicistat-boosted darunavir for the treatment of HIV-1 in adults with no darunavir resistance-associated mutations (GS-US-216-0130).
The efficacy of PREZCOBIX™ is based on efficacy demonstrated in clinical trials of darunavir co-administered with ritonavir and pharmacokinetic trials showing similar exposures of darunavir when boosted with cobicistat compared to darunavir boosted with ritonavir. Two Phase 3 studies in the darunavir clinical development program, ARTEMIS (TMC114-C211) and ODIN (TMC114-C229), studied the once-daily use of darunavir co-administered with ritonavir.
In the GS-US-216-0130 study, which was conducted with darunavir 800 mg and cobicistat 150 mg administered as single entities in 313 HIV-infected patients, adverse reactions evaluated through Week 24 did not differ substantially from those reported in clinical trials with darunavir co-administered with ritonavir 100 mg. During the darunavir clinical development program, where darunavir was co-administered with ritonavir 100 mg once or twice daily, the most common adverse reactions (incidence greater than or equal to 5 percent) of at least moderate intensity (greater than or equal to Grade 2) were diarrhea, nausea, rash, headache, abdominal pain and vomiting.
HIV was first reported in 1981 and remains a challenging disease and public health concern worldwide. Inthe United States today, an estimated 1.2 million people live with HIV and the number of Americans being diagnosed with HIV every year – about 50,000 – has not declined since the mid-1990s.
“Treating HIV remains an urgent healthcare need, and it’s important for adults living with HIV to have regular discussions with a healthcare provider about treatment options that are right for them,” said Richard Nettles, M.D., vice president of Medical Affairs, Janssen Therapeutics. “The approval of PREZCOBIX™ exemplifies Janssen’s ongoing commitment to developing new treatment options for those living with HIV and builds upon the legacy of darunavir.”
Access to PREZCOBIX™
Janssen partners with a variety of stakeholders to support patient access to medicines. For patients, the company offers Janssen Therapeutics Line, a comprehensive support offering designed to help patients start on their therapy with Janssen HIV products. Janssen Therapeutics Line provides benefit verification, assistance with the prior authorization process and information about a variety of affordability programs, including those for patients with commercial insurance, federally funded insurance or no insurance coverage.
Eligible patients with commercial insurance coverage for PREZCOBIX™ may pay $0 each time they fill their prescription with the Janssen Therapeutics Patient Savings Program. This is subject to a $7,500 maximum benefit per calendar year. This program is not valid for patients covered under Medicaid, Medicare or similar state or federal programs. For more information, visit www.PREZCOBIX.com
PREZCOBIX™ (darunavir/cobicistat) tablets is a prescription medicine indicated for the treatment of human immunodeficiency virus (HIV-1) in combination with other antiretroviral agents for treatment-naive and treatment-experienced adult patients with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V). It combines the protease inhibitor darunavir (marketed as PREZISTA® in the United States) with cobicistat, a pharmacokinetic enhancer or boosting agent, developed by Gilead Sciences, Inc., and marketed as Tybost®, for use in combination with other HIV-1 medications taken orally with food.