FDA Approves First Two-Drug Once-Daily Single-Pill HIV Regimen

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(PRNewsfoto/Janssen Therapeutics)

On November 21, 2017, the U.S. Food and Drug Administration (FDA) approved the first-ever two-drug once-daily single-pill regimen for the maintenance treatment of adults who have virologically suppressed HIV-1 on a stable antiretroviral regimen for at least six months with no history of treatment failure.

Juluca, which combines dolutegravir 50mg (ViiV Healthcare), an integrase strand transfer inhibitor, and rilpivirine 25mg (Janssen Therapeutics, Division of Janssen Products LP), a non-nucleoside reverse transcriptase inhibitor, will be available in pharmacies in the U.S. beginning December 11, 2017.

The FDA based its approval upon data from two phase III clinical trials, SWORD-12 and SWORD-2,2 which showed the 2-drug regimen to be just as effective at viral suppression (HIV-1 RNA less than 50 copies per mL) at 48 weeks as a three- or four-drug regimen, with few drug-related adverse effects. The studies included more than one thousand patients with stable viral suppression for at least six months on other antiretroviral regimens and had no virologic failure or known resistance to the two drugs combined in Juluca.

“Today’s approval of JULUCA® marks a significant milestone in the treatment of HIV,” according to Brian Woodfall, Global Head of Late Development, Janssen Research & Development. “As the first single-pill, complete two-drug regimen, JULUCA® maintains the safety and efficacy of a traditional three-drug regimen without an N(t)RTI. This is exciting because it offers those living with HIV who are compliant and stably suppressed a new, simplified treatment option to consider.” John C Pottage, Jr., MD, Chief Scientific and Medical Officer, ViiV Healthcare, commented further, “Based on the fundamental principle that no one should have to take more medicines than necessary,… Juluca, our new 2-drug regimen, once-daily, single pill, now provides people living with HIV… the option to reduce the number of antiretrovirals they take, while maintaining the efficacy of a traditional three-drug regimen.”

Like all HIV medications, Juluca is not without its problems. Four percent of patients who began Juluca discontinued its use due to an adverse event (AE) including psychiatric disorders (depression), diarrhea, or headache.

Hoping to help lessen the burden of treatment for people living with HIV who face a lifetime of taking medications, ViiV Healthcare is developing other two-drug regimens for HIV treatment, including two in phase III development, a once-daily, single pill containing dolutegravir/lamivudine for treatment naïve patients, as well as cabotegravir/rilpivirine, a long-acting injectable for treatment-experienced and treatment-naïve patients.


To learn more about Janssen’s commitment to the prevention and treatment of HIV, please visit www.jnj.com/HIV. For more information on Juluca and/or Viiv Healthcare, visit www.viivhealthcare.com.