The Federal Drug Administration (FDA) recently announced the approval of a pill to treat HIV that only has to be taken once a day. The new combination drug is aimed at adults who have never been treated for HIV.
Stribild, which is manufactured by Gilead Sciences, contains two previously approved HIV drugs – emtricitabine and tenofovir disoproxil fumarate, marketed as Truvada – and two new drugs, elvitegravir and cobicistat. Combined, the FDA said the drugs provide a complete treatment regimen for HIV infection.
“Through continued research and drug development, treatment for those infected with HIV has evolved from multi-pill regimens to single-pill regimens,” said Edward Cox, MD, MPH, director of the Offices of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, in a news release.
“New combination HIV drugs like Stribild help simplify treatment regimens,” added Cox.
The FDA reports that Stribild’s safety and effectiveness were evaluated in two double-blind clinical trials that involved 1,408 adult patients not previously treated for HIV. The trials measured the percentage of patients who had an undetectable amount of HIV in their blood after 48 weeks of treatment.
The results showed that between 88 percent and 90 percent of the patients treated with Stribild had an undetectable amount of HIV in their blood, compared with 84 percent and 87 percent of those treated with two other combination drugs.
FDA-required label warnings
Like many other HIV drugs, Stribild will be required to carry a label warning patients and healthcare providers that the drug can cause potentially fatal side-effects, including severe liver problems and a build-up of lactic acid in the blood.
The FDA also reported common side-effects included nausea and diarrhea. More serious side-effects observed during the trials included new or worsening kidney problems, decreased bone mineral density, fat redistribution and changes in the immune system.
Effective but expensive
While the good news is that Stribild appears to be a convenient and effective treatment, the bad news is its cost: about $28,500 a year.
“That’s shockingly irresponsible,” Michael Weinstein, president of the AIDS Healthcare Foundation, told the New York Times. “It’s just unsustainable at these levels,” he said.
Edith Rau, a spokeswoman for Gilead, emailed a response to the New York Times stating that the price “reflects a reasonable return on our product development investment.”
Rau added that the company would provide discounts to state AIDS Drug Assistance Programs, and would also offer various programs to help privately insured patients obtain the drug.