Gilead Sciences' once-daily HIV pill, which combines four drugs, is considered safe and effective, according to a Phase 3 study conducted in the US.
The 'quad pill', which has been co-formulated with a class of antiretroviral drugs: elvitegravir (EVG), cobicistat (COBI), emtricitabine and tenofovir disoproxil fumarate (TDF), is expected to make it easier for patients to stick to their medication.
The study, published in the Lancet, involved 708 treatment-naïve patients who were randomly treated with either the quad pill boosted with ritonavir (RTV), or a therapy combining Bristol-Myers Squibb's atazanavir with RTV, FTC and TDF, plus matching placebos.
Scientists, led by Paul Sax, a clinical director at Brigham and Women's Hospital, in Massachusetts, found that both therapies were safe and effective, but fewer patients receiving EVG had abnormal results in liver function tests compared to those receiving ATV.
Fewer EVG patients, however, discontinued treatment because of adverse events.
If regulatory approval is granted, the quad pill would be the first integrase inhibitor-based regimen given once daily and the only one formulated as a single tablet for initial HIV treatment.
Image: The quad pill is expected to make it easier for patients with HIV to stick to their medication. Image courtesy of: C. Goldsmith.