The Department of Health and Human Services (HHS) updated antiretroviral treatment guidelines to state that Edurant, which is also a component of Complera, is considered an alternative, but not preferred, antiretroviral for people starting HIV treatment for the first time.

Sustiva (efavirenz), which is in the same antiretroviral class as Edurant (rilpivirine) and an ingredient in Atripla (efavirenz/emtricitabine/tenofovir), is still considered the preferred treatment.

Edurant is a non-nucleoside reverse transcriptase inhibitor (NNRTI) marketed by Tibotec Pharmaceuticals, a subsidiary of Johnson & Johnson. Edurant was approved by the U.S. Food and Drug Administration (FDA) in May.

In addition, Edurant is a component of the once-daily combination pill Complera (rilpivirine/emtricitabine/tenofovir), which was approved by the FDA last week. Complera, which is marketed by Gilead Sciences, is intended as an alternative to Atripla, which is currently the most commonly prescribed first-line regimen for HIV.

Edurant and Complera were approved based on clinical trials showing that they are as effective as Sustiva and Atripla in people who have not previously been treated for HIV. However, the FDA noted at the time that the drugs were not as effective in people starting treatment with viral loads (amount of HIV in the blood) higher than 100,000 copies per milliliter.

In addition, patients taking Edurant or Complera who failed therapy were more likely to show drug resistance than patients taking Sustiva or Atripla.

As a result, HHS has decided to list Edurant as an alternative NNRTI for people starting treatment for the first time, while keeping Sustiva as the preferred NNRTI. The recommendation also affects Complera, which contains Edurant.

HHS defines an alternative regimen as one that is safe and effective but may have disadvantages compared to preferred regimens. Alternative antiretrovirals may be preferred for some individuals due to side effects, allergic reactions, drug resistance, or other factors.

HHS also noted that there is insufficient information on the safety and efficacy of Edurant and Complera in pregnant HIV-positive women. Edurant and Complera are not recommended for children under 18 because appropriate dosages have not yet been determined for this age group.

In addition, HHS warned against use of Edurant and Complera in combination with stomach acid reducers.  Specifically, the antiretrovirals should not be used with proton pump inhibitors, such as omeprazole (Prilosec) and Nexium (esomeprazole), and should be used with caution with antacids and H₂ receptor antagonists, such as cimetidine (Tagamet) or famotidine (Pepcid).

For more information, please see the AIDSinfo website.