Safety of Gilead Sciences' Quad regimen for HIV generally acceptable: FDA staff

May 09, 2012-Industry News
Safety of Gilead Sciences' Quad regimen for HIV generally acceptable: FDA staff
Last Updated:May 09, 2012 11:36

In documents released by the FDA Wednesday, agency staff said that Gilead Sciences' Quad regimen for HIV had a "generally acceptable" safety profile. An advisory panel is scheduled to meet on May 11 to review the once-daily drug, which combines elvitegravir, cobicistat and Truvada (emtricitabine/tenofovir), with the regulator expected to make a final decision by August 27.

In background material, the FDA reviewers said that in clinical trials the Quad regimen met study goals looking at effectiveness by reducing viral load in patients, while adverse events were similar compared to those being treated with other HIV therapies. However, the staff noted that there were a higher number of adverse renal events among those that received the Quad, including four cases of kidney failure.

The agency staff said this raised the possibility that patients taking the drug may need to undergo additional testing to monitor for kidney complications. The reviewers noted that there were fewer patients who stopped taking Quad early because of side effects. The report also cautioned that the safety profile of Quad for women could be limited because only a small number of women were included in clinical trials.

Deutsche Bank analyst Robyn Karnauskas remarked that she wasn't concerned that the kidney risk may prevent the drug from getting to market. "It is just a minor detail, which is why I’m not worried," she said.

Clinical trial results supporting the application showed that the Quad tablet had similar efficacy to
Atripla (efavirenz/emtricitabine/tenofovir) in treatment-naïve adults. Results of the study showed that at 48 weeks of treatment, 88 percent of patients who took Quad achieved undetectable levels of HIV in their blood, compared with 84 percent of those who received Atripla. A second study demonstrated that the Quad regimen was non-inferior to Bristol-Myers Squibb's Reyataz (atazanavir) plus Truvada in treatment-naive patients. Data indicated that after 48 weeks of treatment, 90 percent of patients in the Quad arm and 87 percent of subjects who received Reyataz and Truvada achieved an HIV viral load of less than 50 copies/mL.

Karnauskas commented that "it is really important for Gilead as a stock that the Quad comes to market and there is nothing bad in the data." She noted that if approved, the medicine may generate as much as $4 billion in annual sales. "It will really hurt the stock if this drug doesn’t come to market," Karnauskas said, as Gilead faces losing half of its revenue from patent expirations on HIV therapies starting in 2018.

Reference Articles

Gilead’s Quad Pill Raises Questions on Kidney Safety, FDA Says - (Bloomberg)
FDA: Safety Of Proposed Gilead HIV Drug "Generally Acceptable" - (The Wall Street Journal)
Gilead's Quad HIV pill appears to be effective-FDA staff - (Yahoo!News)