The findings of two large international randomized studies published in The Lancet medical journal indicate that the new once-daily pill combining three antiretrovirals and a booster molecule is a safe and effective alternative to two widely used drug regimens for newly diagnosed HIV-positive adults who have had no previous treatment. The study results also indicate that the new "Quad" pill is faster acting, doesn't have the neuropsychiatric side effects associated with other combinations, and could improve compliance with treatment.
"Patient adherence to medication is vital, especially for patients with HIV, where missed doses can quickly lead to the virus becoming resistant to medication. Older HIV treatment regimens involve taking several pills multiple times a day," explains Paul Sax from Brigham and Women's Hospital, Harvard Medical School, lead author of the first study. "Our results provide an additional highly potent, well-tolerated treatment option, and highlight the simplicity of treatment resulting from combining several antiretrovirals in a single pill. Studies have shown that single pill treatments improve both adherence and patient satisfaction, and help prevent prescription errors, thereby reducing the likelihood of treatment failure and drug resistance."
The first study randomly assigned 700 patients from centers across North America to start treatment with two different single tablet regimens -- either the Quad, combining the new integrase inhibitor elvitegravir (EVG) boosted with cobicistat (a new pharmacoenhancer; COBI) plus emtricitabine/tenofovir (Emtriva/Viread), or Atripla (efavirenz/emtricitabine/tenofovir), the current gold standard regimen approved by the FDA in 2006.
Adverse events that led to patients discontinuing treatment were infrequent and similar in both groups. Mild nausea was more common with the Quad, but patients were less likely to have dizziness, abnormal dreams, insomnia, and rash compared with the Atripla regimen.
The second trial included 708 treatment-naive adults from 146 medical centers across Australia, Europe, North America, and Thailand. Patients were randomly assigned to receive a once-daily Quad or a popular and recommended twice-daily combination of Norvir-boosted Reyataz (atazanavir/ritonavir) plus Truvada (emtricitabine/tenofovir).
The primary endpoint, to achieve viral levels below 50 copies/mL by week 48, was reached by 90% of people in the Quad group compared with 87% in the atazanavir/ritonavir/emtricitabine/tenofovir group.
The safety of the two regimens was also similar.
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