Results from the STaR (Single Tablet Regimen) Study show overall that Complera controlled HIV as well as Atripla by week 48. However, Complera controlled HIV better in people who started treatment with viral loads below 100,000. This study included only people who started treatment for the first time. Both are full regimen pills taken once a day.
Since Atripla became the first full regimen pill on the market in 2006 and has shown to control HIV well over time, newer one-pill regimens like Complera (and Stribild) are being compared to it in clinical studies. The US Guidelines currently recommends the drugs in Atripla (Sustiva/efavirenz + Viread/tenofovir + Emtriva/emtricitabine) as one of several regimens for people going on treatment for the first time. Complera includes the new NNRTI called Edurant/rilpivirine along with Viread/tenofovir + Emtriva/emtricitabine.
| STaR Study, characteristics of enrolled participants w/ viral loads >2,500 | ||
| Complera | Atripla | |
| Number of people | 394 | 392 |
| CD4 count average | 396 | 385 |
| Viral load <100,000 | 66% | 64% |
| Viral load 300,000-500,000 | 25% | 30% |
| Viral load >500,000 | 9% | 6% |
| STaR Study, virologic results at 96 weeks | |||
| Complera | Atripla | statistically significant? | |
| Undetectable (overall) | 86% | 82% | no |
| Undetectable (started <100,000) | 89% | 82% | yes |
| Undetectable (started >100,000) | 80% | 82% | no |
| CD4 count change | +200 | +191 | no |
| Failed regimen (started <100,000) | 5% | 3% | no |
| Failed regimen (started 300,000-500,000) | 10% | 9% | no |
| Failed regimen (started >500,000) | 25% | 16% | yes |
| Mild side effects | 7% | 14% | yes |
| STaR Study, results of other lab work at 96 weeks | |||
| Complera | Atripla | statistically significant? | |
| Total cholesterol change | +1mg | +22mg | yes |
| LDL cholesterol change | +1mg | +14mg | yes |
| HDL cholesterol change | +2mg | +8mg | yes |
| Triglycerides change | -8mg | +8mg | yes |
| Estimated GFR (kidney) | -5.4mL | +4.6mL | yes |
| Resistance mutations | 4% | 1% | no |
For slides on these results, click here.