First Complete Two-Drug HIV Regimen Receives FDA Approval

Today, the FDA approved Juluca, a regimen of dolutegravir (ViiV Healthcare) and rilpivirine (Janssen), to treat HIV-1, making it the first complete 2-drug therapy for the condition. Other HIV therapies contain 3 or more drugs, according to a press release.

Juluca is a complete HIV therapy that can replace antiretroviral therapy (ART) among virally-suppressed patients who have been treated with ART for at least 6 months, according to the FDA. The drug is indicated to treat HIV-positive patients who have not previously experienced treatment failure.

“Juluca provides a 2-drug maintenance regimen for select individuals who are virologically suppressed. This group of select individuals will clearly benefit from this once-daily NRTI-sparing regimen. As we recognize World AIDS Day 2017, we are also aware that this approval represents a paradigm shift in the treatment of HIV-infected patients" Debra Birnkrant, MD, director of the Division of Antiviral Products in the FDA Center for Drug Evaluation and Research, said in a press release.

The new approval was based on positive findings from SWORD 1 and SWORD 2 clinical trials. Included in the studies were 1024 patients who achieved viral suppression on current HIV drugs. Patients were randomized to remain on ART or switch to dolutegravir and rilipivirine, the components of Juluca, according to the FDA.

Overall, the authors found that patients administered Juluca maintained high levels of viral suppression compared with patients who remained on ART.

The primary efficacy endpoint of the clinical trials was the number of patients with plasma HIV-1 RNA less than 50 copies per mL at 48 weeks, also known as viral suppression.

The investigators discovered that 95% of patients from both cohorts achieved viral suppression, according to the release.

Only 0.6% of patients treated with dolutegravir plus rilpivirine did not achieve viral suppression, while 1.2% of the ART cohort failed to meet this metric, according to the FDA.

Common adverse events associated with dolutegravir plus rilpivirine include diarrhea and headache.

The FDA warns that Juluca is contraindicated with dofetilide and with drugs in which significant decreases in rilpivirine plasma occur, which may cause a loss of viral suppression. These drugs include: anticonvulsants (carbamazepine, oxcarbazepine, phenobarbital, and phenytoin), antimycobacterials (rifampin and rifapentine), systemic glucocorticoids (dexamethasone), herbal products (St John’s wort), and proton pump inhibitors (such as esomeprazole, lansoprazole, omeprazole, pantoprazole, and rabeprazole), according to the FDA.

The recommended dose is 1 tablet per day with a meal, according to the FDA. Since Juluca is a complete HIV therapy, the FDA warns against the use of other ART drugs.