Once-daily Quad HIV pill an effective and safe alternative to multiple-pill regimens, study shows
The authors of the study are hopeful the new medicine could serve as an alternative to some existing HIV treatment regimens that require patients to take multiple pills several times per day.
"Patient adherence to medication is vital, especially for patients with HIV, where missed doses can quickly lead to the virus becoming resistant to medication," study author Dr. Paul Sax, a professor of infectious diseases at Harvard Medical School and a physician at Brigham and Women's Hospital in Boston, said in a press release. "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."
Quad is the first pill to include an integrase inhibitor, a type of HIV drug that blocks the virus from replicating, along with three other guideline-recommended antiviral agents.
The study, published in the June 28 issue of The Lancet, reported on two trials of the Quad pill that compared the drug to existing treatment options. For the first trial, researchers assigned 700 patients to start treatment with either the Quad or another single-pill regimen that combines three treatments called Atripla, which is considered the "gold standard" regimen according, to the study. Atripla was approved by the FDA in 2006.
Following 48 weeks of treatment, 88 percent of patients given Quad suppressed their virus to undetectable levels, compared with 84 percent on the other regimen. Mild nausea was more common with people taking Quad, but patients were less likely to experience dizziness, abnormal dreams, insomnia and rash compared with subjects taking the three-drug regimen.
The second experiment involved 708 patients who were given either once-daily Quad or a popular twice-daily drug combination of two antiviral agents, ATV/RTV plus FTC/TDF. Ninety-percent of patients saw a significant drop in viral levels compared with 87 percent taking the other regimen. Side effects were also similar, however more kidney complications were reported in patients taking Quad compared with other treatments.
"Without a doubt the achievement of a one-a-day pill has been a big advance in tackling HIV," Dr. Steve Taylor, an HIV specialist at Birmingham Heartland Hospital in the U.K., told the BBC. "We've come a long way from people taking up to 40 pills three times a day."
Quad is currently under review by the FDA after panel of experts voted 13 to one to recommend its approval, Reuters reported, with a final decision expected by August 27.
In an accompanying commentary published in the same journal, Belgian researchers Rik Schrijvers and Zeger Debyser from the Katholieke Universiteit Leuven said Quad is an effective and tolerable drug but it needs to be taken with food and there's potential for interactions with other drugs. They wrote that more research is needed on the long-term safety data, especially looking at long-term toxic effects to the kidneys.
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