Patients Ineligible for First-Line HIV Drug Have Other Effective Options

Study finds that HIV drug regimens that exclude efavirenz are as effective as first-line antiretroviral treatment.

Patients excluded from a first-line HIV treatment can still take a drug regimen that provides similar efficacy, according to the results of a recent study.

Efavirenz is the first-line HIV therapy typically recommended by the US Department of Health and Human Services and World Health Organization guidelines. Some patients are ineligible for efavirenz, however, including women considering becoming pregnant and patients with a history of severe psychiatric disorders.

In a recent phase 3 clinical trial, HIV drug regimens that do not include efavirenz were found to be just as effective as those that do.

The randomized trial, conducted by researchers from the AIDS Clinical Trials Group, included 3 efavirenz-free regimens with 1809 participants age 18 or older with HIV-1 RNA levels greater than 1000 copies/mL. The patients, who were followed for 96 weeks, also had no prior treatment with antiretroviral therapy.

The 3 treatment groups received either 300 mg/d of atazanavir with 100 mg/d of ritonavir; 800 mg/d of darunavir with 100 mg/d of ritonavir; or 400 mg/bid of raltegravir.

Additionally, each participant also received 200 mg/d of emtricitabine and 300 mg/d of tenofovir disoproxil fumarate with the assigned regimen.

The study showed that each arm of the treatment regimen was able to attain high and equivalent rates of HIV control in the blood, along with restored function of the immune system. There was, however, differences in tolerability among the treatment groups.

The regimens of raltegravir or ritonavir-boosted darunavir exhibited superior tolerability compared with the ritonavir-boosted atazanavir group.

In an evaluation of the combined impact for both tolerability and virologic response together, raltegravir-based therapy was found to be superior overall to both other therapies, while ritonavir-boosted darunavir was found to be superior to ritonavir-boosted atazanavir.

"We are very pleased that our study showed the drug combinations tested, without efavirenz, are good options for initial HIV antiretroviral therapy,” principal investigator Jeffrey Lennox, MD, said in a press release. “This is critical information for patients who cannot tolerate efavirenz, and we believe this head-to-head comparison will provide useful information to guide clinicians about choosing among them.”