A U.S. Food and Drug Administration advisory panel of independent experts has recommended approval for Gilead Sciences Inc.’s new once-a-day Quad pill for HIV-treatment.

The FDA Antiviral Drugs Advisory Committee voted 13 to 1 on Friday for the four-drugs-in-one pill that includes emtricitabine and tenofovir, and two investigational drugs integrase inhibitor elvitegravir and boosting agent cobicistat.

However because some patients in the drug’s clinical trials had experienced kidney problems, the panelists said that the drug still needs to be monitored. The members of the panel also urged more research to determine Quad’s safety profile for women, who have been underrepresented in the drugs clinical trials.

While the FDA is not required to follow the panel’s advice, the agency usually does, and a final decision is expected by August 27.

While the majority of panel experts were satisfied with Quad’s safety and efficacy, Dr. Michelle Estrella of Johns Hopkins University School of Medicine, the only member of the panel that did not recommend Quad’s approval, said that the potential kidney problems and limited information on the drug’s safety for women did not warrant her approval.

"There are plenty of alternatives to Quad," Estrella said, according to Reuters. "There's no huge hurry in approving this drug before the outstanding studies are completed."

Other common side effects of the drug include nausea, diarrhea, upper respiratory tract infection and headache.

Gilead is seeking FDA approval for the drug to be prescribed to untreated HIV patients or patients who have been previously treated but without resistance to any of the drug’s components.

The one-pill, once-daily Quad regimen is designed to provide more convenience to HIV patients, many who currently take multiple pills a day, and to have fewer side effects than current treatments.

Gilead’s research shows that Quad was 88 percent effective at suppressing HIV infection, but a disproportionate number of kidney problems were reported among the hundreds of patients who took part in the clinical trials.

If approved, the pill would be the first ever once-daily integrase inhibitor, a class of drug made to block the spread of HIV infection by stopping the virus from merging with the DNA of host cells, and advocates say that the one-a-day regime would encourage patients to adhere to the Quad treatment, which would increase the likelihood of the drug being effective outside of clinical experiments.

"With new government guidelines recommending that people diagnosed with HIV begin treatment early, it is important that we continue to simplify and improve HIV therapy," Dr. Andrew Cheng, Senior Vice President of HIV Therapeutics and Development Operations at Gilead Sciences, said in a company news release. "The Quad is the latest example of Gilead's ongoing efforts to develop highly effective and well tolerated single tablet regimens for people living with HIV."

The U.S. Centers for Disease Control and Prevention reported that nearly 1.2 Americans have HIV, and there are 50,000 new cases of the infection each year.

On Thursday the same FDA panel recommended approval for Gilead’s double drug Truvada, a combination of emtricitabine and tenofovir, to treat and prevent HIV infection in healthy people who are at risk for contracting the infection, including gay and bisexual men and heterosexual couples whose partners have the disease.

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