December 17, 2013
FDA OKs Switching From Stable HIV Regimen to Complera
The U.S. Food and Drug Administration (FDA) has approved Gilead Sciences’ coformulated triple antiretroviral (ARV) combination tablet Complera (emtricitabine/rilpivirine/tenofovir) for those HIV-positive adults who switch from a stable ARV regimen.
“Complera is an effective single-pill therapy with a demonstrated safety profile, and has rapidly become an important option for appropriate HIV patients who are initiating antiretroviral treatment,” Calvin J. Cohen, MD, MSc, research director of the Community Research Initiative of New England and an investigator on clinical trials of Complera, said in a release. “The data supporting today’s approval demonstrate Complera has the potential to help a broader range of HIV-infected patients who have achieved virologic control on another regimen.”
Those who switch their HIV regimen to Complera should never have experienced virologic failure, have at least six months of an undetectable viral load, and never have had resistance to the drugs in Complera.
The FDA approval is a result of the randomized, open-label Phase III SPIRIT clinical trial, in which participants with fully suppressed viral loads who were taking ritonavir-boosted, protease inhibitor–based multidrug ARV regimens either switched to Complera or remained on their same regimen. After 48 weeks of Complera, 89 percent (283/317) of the participants in the switching arm had a fully suppressed viral load, compared with 90 percent (143/159) of those in the protease inhibitor arm, who were followed for 24 weeks.
To read the Gilead release, click here.
Search: U.S. Food & Drug Administration, FDA, Gilead Sciences, Complera, emtricitabine, rilpivirine, tenofovir, HIV, Calvin J. Cohen, switch.
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