May 20, 2011
The FDA approval came from a review of the ECHO and THRIVE clinical studies that compared Edurant to Sustiva. In ECHO, everyone also took Truvada (Viread + Emtriva). In THRIVE, people also took one of three combination pills: Truvada, Epzicom (Ziagen + Epivir) or Combivir (Retrovir + Epivir).
After 48 weeks, very similar results occurred: 83% of those on Edurant and 80% on Sustiva reached undetectable viral loads. Only 2% of those on Edurant stopped the studies due to side effects, while only 7% on Sustiva stopped.
Although offering this new option to people who start treatment for the first time is welcome news, there's a major difference in how well Edurant controlled HIV in people who started with viral loads above 100,000. In those who started between 100,000-500,000 copies, 20% on Edurant could not control their viral levels compared to 11% on Sustiva. For those above 500,000, 29% on Edurant and 17% on Sustiva could not.
Equally as concerning, people who took Edurant with higher viral loads also experienced more resistance mutations. More resistance occurred to the other five drugs used in the studies when people took Edurant (48%) compared to Sustiva (15%). People with higher viral loads may want to choose another NNRTI when starting their first regimen.
People who took Edurant experienced fewer overall side effects. The most common were rash, headache, depression, and trouble sleeping. The most common side effects that led to people quitting the studies were psychiatric and occurred in 1% of those on Edurant and 2% on Sustiva.
Although it may take another year to realize, the next step for this drug is for it to be combined with Truvada into a single pill, creating a new competitor to Atripla.