Juluca Maintains HIV Viral Suppression Through 100 Weeks

Today ViiV Healthcare presented 100-week results from 2 phase 3 studies of the safety and efficacy of dolutegravir and rilpivirine. The SWORD studies are evaluating the long-term effects of switching patients with HIV who are virologically suppressed from a 3- or 4-drug antiretroviral regimen to the 2-drug combination (Juluca).

At the 100-week mark, 89% (456/513) of participants taking dolutegravir/rilpivirine maintained viral suppression, with viral loads of < 50 copies/mL.

“As we progress further into a new era of HIV treatment, these 100-week data from the SWORD studies add to the growing evidence base for Juluca and 2-drug regimens,” John C. Pottage, Jr, MD, Chief Scientific and Medical Officer, ViiV Healthcare said in a statement.

Of the 513 SWORD participants taking dolutegravir/rilpivirine for 100 weeks, 3% (n = 13) experienced snapshot virologic non-response, and just 6 met the confirmed virologic withdrawal criterion. A total of 34 (7%) of participants withdrew due to adverse events through week 100.

“The results confirm the ability of Juluca to maintain efficacy over a 100-week period and importantly support that the long-term safety profile of this regimen is consistent with the respective labels of the component medicines,” added Pottage. “This 100-week data should provide physicians with further confidence that they may be able to reduce the number of antiretroviral drugs required to effectively maintain virologic suppression in their patient’s HIV.”

In a “late switch” arm of the study, where 477 participants remained on their standard antiretroviral treatment until week 53 before switching to dolutegravir/rilpivirine, 93% (n = 444) maintained viral suppression through week 100.

Just 2 of the “late switch” patients met the confirmed virologic withdrawal criterion. In this study arm, 30 participants (6%) experienced serious adverse events and 15 (3%) withdrew due to adverse events.

Juluca, which is comprised of 50 mg dolutegravir and 25 mg rilpivirine, was first approved by the FDA in November 2017 based in part on data from the first 48 weeks of the SWORD 1 and SWORD 2 studies. Juluca is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable antiretroviral regimen for at least 6 months, with no history of virological failure and no known or suspected resistance to any nucleoside reverse transcriptase inhibitor (NNRTI) or integrase inhibitor (INI).

The 48-week results from SWORD 1 and SWORD 2 were first presented at CROI 2017, the Conference on Retroviruses and Opportunistic Infections. At the conference, Katia Boven, MD, Head of Clinical Development and Global Medical Affairs, Infectious Diseases, Janssen, spoke with MD Magazine® about the SWORD trials and the benefits of a 2-drug dolutegravir/rilpivirine regimen.

"Currently, most patients are in a triple or quadruple regimen and every drug carries some safety or tolerability issues—maybe not in the short term, but in the longer term after 5, 10, or 15 years of having to take the drugs,” Boven told MD Magazine® at the time.

Juluca has been approved for use in the US since Nov 2017, in the European Union and Canada since May 2018, and in Australia since June 2018.

The results of the SWORD 1 and SWORD 2 studies at 100 weeks were presented at the 22^nd International AIDS Conference taking place in Amsterdam, July 23-27, 2018.