On Monday, The Food and Drug Administration approved the sale of Stribild, a pill that combines four HIV medicines into one.
The FDA cleared the treatment, saying in a statement that combination HIV drugs will help simplify patients’ treatment regimens. Stribild contains two new drugs and two previously approved compounds that make up Foster City, California-based Gilead’s Truvada HIV therapy.
The product, previously called the Quad pill, is meant to treat people infected with the human immunodeficiency virus who haven’t been previously treated with other HIV medicines.
FDA said the Stribild provides a complete treatment regimen for HIV infection, the virus that causes AIDS, in one pill. It combines Gilead’s existing HIV drug Truvada, which contains the ingredients emtricitabine and tenofovir, and two new ingredients, elvitegravir and cobicistat.
HIV must be treated with more than one drug, and until recent years patients needed to take multiple pills daily.
There is an existing three-medicine product, Atripla, that can also be used alone or in combination with other HIV drugs. Atripla is a combination of Gilead’s Truvada withBristol-Myers Squibb Co.’s Sustiva.
One of two studies submitted to the FDA in support of Stribild’s approval compared it to Atripla as initial therapy for HIV infection. The study, involving about 700 patients, met its goal of showing both drugs were similar in treating HIV by suppressing the so-called viral load. The study found that 88% of Quad recipients had viral suppression 48 weeks after starting treatment, versus 84% of Atripla users. The other 700-patient study compared the Stribild to patients taking Truvada in addition to another HIV drug, atazanavir/ritonavir and showed the Quad reduced viral load in 90% of patients after 48 weeks compared with 87% of patients being treated with the other drugs.
Stribild’s approval is the latest HIV/AIDS-related action taken by the FDA this year. Other actions include approval of the first over-the-counter home-use rapid HIV test; approval of the first drug for pre-exposure prophylaxis in combination with safer sex practices to reduce the risk of sexually acquired HIV infection in adults at high risk; and commemoration of the full or tentative approvals of more than 150 antiretroviral products for the President’s Emergency Plan for AIDS Relief (PEPFAR) to treat those in countries most affected by the HIV/AIDS epidemic.
Like labels of many other drugs used to treat HIV, Stribild’s label carries a Boxed Warning alerting patients and health care professionals that the drug can cause a build up of lactic acid in the blood and severe liver problems, both of which can be fatal. The Boxed Warning also states that Stribild is not approved to treat chronic hepatitis B virus infection.
Common side effects observed in clinical trials include nausea and diarrhea. Serious side effects include new or worsening kidney problems, decreased bone mineral density, fat redistribution and changes in the immune system (immune reconstitution syndrome). Stribild’s label gives advice to health care providers on how to monitor patients for kidney or bone side effects.
Gilead Sciences, Stribild’s manufacturer, is required to conduct additional studies to help further characterize the drug’s safety in women and children, how resistance develops to Stribild, and the possibility of interactions between Stribild and other drugs.
Stribild was approved with the FDA’s toughest boxed warning.
Contributor D. Chandler