Stribild Gets FDA Approval as New Single-Tablet Regimen
Stribild (formerly known as the Quad), a complete once-daily single-tablet regimen (STR), was approved by the FDA in August. Stribild joins Atripla and Complera as a complete HIV regimen in one pill, each taken once daily.
The FDA based approval on studies in which Stribild showed non-inferiority at 48 weeks to two standard of care regimens on the market, Atripla or Norvir-boosted Reyataz with Truvada.
Stribild was approved for people taking HIV medications for the first time, although some doctors may inevitably prescribe it for patients switching to a new antiviral therapy.
The Department of Health and Human Services (DHHS) acted right away to update its HIV treatment guidelines, adding Stribild as an alternative regimen, with a B1 rating indicating a "moderate" recommendation based on randomized controlled studies (the gold standard of research). In contrast, Isentress/Truvada (Stribild's most direct competition based on main drug class) has an A1 recommendation -- "strong" based on randomized controlled studies.
Stribild consists of four drugs: the experimental integrase inhibitor elvitegravir, emtricitabine, tenofovir, and cobicistat. Cobicistat has no anti-HIV property; it is used to boost blood levels of elvitegravir. The only other integrase inhibitor on the market is Isentress. Emtricitabine and tenofovir are available as the antiviral Truvada, which is now also approved as PrEP, or pre-exposure prophylaxis for HIV prevention.
DHHS noted, "Limitations include a significant potential for drug-drug interactions, the availability of only 48 weeks of safety data, usage limited to individuals with pre-treatment creatine clearance levels above 70 mL [a kidney laboratory measure], a possible increased risk of proximal renal tubulopathy [a kidney complication], limited data in patients with advanced HIV disease and in women, and the need for the drug to be taken with food."
Gilead Sciences, maker of Stribild and Complera, as well as two of the three drugs in Atripla, established an access program for Stribild for people without insurance and a co-pay assistance for patients with private insurance. Gilead's U.S. Advancing Access program can be reached at 1-800-226-2056.
In addition, the company reached a pricing agreement with the ADAP Crisis Task Force, creating a lower price for state AIDS Drug Assistance Programs (ADAPs). Nevertheless, the task force acknowledged the disappointment and controversy within the larger HIV community about Stibild's $28,500 annual price tag. According to a task force press release, setting the price of Stribild higher than Atripla, despite being less than several protease inhibitor-based regimens, may affect costs outside of ADAP.