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FDA Approves the New Full-Regimen HIV Pill Complera

August 12, 2011

A new combination pill called Complera was approved by the FDA on August 10, 2011 for treating HIV infection. The pill, taken once a day with a fatty meal, combines two NRTIs [tenofovir (Viread) + emtricitabine (Emtriva)] with the recently approved NNRTI called rilpivirine (Edurant).

This makes Complera the second full regimen of HIV meds taken as one pill, similar to that of Atripla, or efavirenz (Sustiva) + tenofovir + emtricitabine. Although Complera is approved for people going on treatment for the first time, not everyone should take the pill. The federal Guidelines panel continues to make efavirenz a preferred first line regimen and rilpivirine is now considered a new alternative regimen.

The ECHO and THRIVE studies compared two groups of people: those on Complera to those on efavirenz + 2 NRTIs, most often which was Atripla. The combined study results found near equal suppression of HIV: 83% on rilpivirine were undetectable vs. 81% on Sustiva at week 48. (In newer data from July, 78% of people on either regimen were still undetectable at week 96.)

However, for those who started with viral loads above 100,000, efavirenz suppressed HIV more often, leading the FDA to caution against starting rilpivirine (or Complera) in those individuals. 13% of those on rilpivirine stopped the study due to the return of detectable viral loads after being undetectable for some time, compared to 8% on efavirenz. Of these individuals, 44% on rilpivirine showed resistance to the drug compared to 23% on efavirenz with resistance to efavirenz. Further, when these virologic failures occurred, more people on rilpivirine had both a higher rate of cross-resistance to other NNRTIs and a higher rate of new resistance to tenofovir and much more often to emtricitabine, compared to those on efavirenz.

The most common side effects for Complera were sleeplessness and headache (due to the rilpivirine) and diarrhea, nausea, tiredness, headache and rash (tenofovir + emtricitabine). These side effects tended to be less severe and less common in those taking Complera (2% stopped the study) compared to efavirenz (7% stopped). Rilpivirine and Complera should not be taken with antacids.

Both tenofovir and emtricitabine are active against hepatitis B, so people with hep B should use Complera with caution. Tenofovir can increase kidney problems in some people, so people with moderate to severe kidney disease (creatinine clearance <50 mL) should not start Complera.

Complera has not been studied in people who have already been on treatment.




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