FDA Approves First Complete 2-Drug HIV Regimen for Adults
Diarrhea and headache were the most commonly reported adverse effects of Juluca.
The Food and Drug Administration (FDA) has approved Juluca (dolutegravir and rilpivirine 50mg/25mg tablets; ViiV and Janssen) as the first complete 2-drug treatment regimen for certain adults with HIV-1 infection instead of the ≥3 drugs included in standard HIV treatment.
Juluca is intended for use in adults with HIV-1 infection to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen for ≥6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Juluca.
The safety and efficacy of Juluca were studied in 2 trials involving 1,024 patients who were virologically suppressed on their current antiretroviral regimen. Patients were randomized to continue their current antiretroviral agents or switch to Juluca. The data indicated Juluca was effective in sustaining virological suppression and was comparable to those who continued on their original regimen.
At Week 48, the proportion of patients with HIV-1 RNA <50 copies/mL was 95% for both treatment groups (treatment difference –0.2%, 95% CI: –3.0, 2.5). The proportion of patients with HIV-1 RNA ≥50 copies/mL (virologic failure) at Week 48 was 0.6% and 1.2% for the Juluca group and the current antiretroviral regimen groups, respectively (treatment difference –0.6%, 95% CI: –1.7%, 0.6%).
Diarrhea and headache were the most commonly reported adverse effects of Juluca; serious effects included skin rash, allergic reactions, liver problems, depression, or mood changes.
Juluca combines dolutegravir, an HIV-1 integrase strand transfer inhibitor (INSTI), and rilpivirine, a non-nucleoside reverse transcriptase inhibitor. The product will be available as 50mg/25mg fixed-dose tablets.
Juluca® (dolutegravir and rilpivirine) approved in US as first 2-drug regimen, once-daily, single pill - a complete regimen for the maintenance treatment of virologically suppressed HIV-1 infection [press release]. London, England: ViiV Healthcare. Published November 21, 2017. Accessed November 27, 2017.