Long-Acting Two-Drug Injectable HIV Regimen Proves Successful in Phase 2 Trial

The results of a Phase 2 trial for a 2-drug regimen of long-acting cabotegravir and rilpivirine and a 3-drug regimen in patient with HIV showed comparable viral suppression rates at 96 weeks, according to a recent press release from ViiV Healthcare.

The study, dubbed the LATTE-2 study, “is a phase 2b, open-label study investigating the long-acting, injectable formulations of cabotegravir (ViiV Healthcare) and rilpivirine (Janssen Sciences Ireland UC) as a 2-drug treatment for patients with HIV-1 infection who had already achieved viral suppression with a 3-drug oral regimen of cabotegravir plus 2 nucleoside reverse transcriptase inhibitors (NRTIs). It is an ongoing international multicentre, parallel group, open-label study that included 309 HIV infected adults who had not received prior anti-retroviral treatment.,” according to the press release.

Furthermore, “Enrolled patients were suppressed virologically (HIV-1 RNA <50 c/mL) during a 20-week induction period with daily oral cabotegravir (30mg) + 2 NRTIs and subsequently randomized to one of three study arms in the maintenance period: intramuscular cabotegravir long acting formulation (400mg) + rilpivirine long acting formulation (600 mg) every four weeks; intramuscular cabotegravir long acting formulation (600mg) + rilpivirine long acting formulation (900mg) every eight weeks; or oral cabotegravir (30mg) + 2 NRTIs. The primary endpoint evaluated antiviral activity and safety through 32 weeks of maintenance treatment and the study will continue up to 104 weeks of treatment.” The results of the study were recently presented at the 9th IAS Conference on HIV Science in Paris, France and published online in The Lancet.

According to the press release, “Fixed-dose oral treatments containing 3 or more medicines have advanced HIV treatment by reducing pill burden and providing convenience for people living with HIV. As research into new medicines for HIV progresses, adherence to therapy continues to be essential to achieving viral suppression and reducing the emergence of resistance mutations. The LATTE-2 study sought to evaluate injectable cabotegravir and rilpivirine dosed once every 4 or 8 weeks compared with daily oral dosing with cabotegravir + 2 NRTIs.”

After a total of 96 weeks of maintenance treatment, the viral suppression rates were shown to be 94% for the 2-drug regimen at dosing every 8 weeks, and 87% for dosing every 4 weeks. These results were comparable to those observed for patients on a 3-drug oral regimen (84%). Of note: “2 patients in the 8-week dosing group and 1 patient in the oral regimen group met protocol-defined virologic failure criteria; neither patient had evidence of resistance at failure,” according to the press release. Pain at the injection site was the “most commonly reported injection site reaction (ISR) reported by patients receiving injectable cabotegravir 2 and rilpivirine.”

“These study results are important because we now have data showing the durability and tolerability of long-acting viral suppression for a two-drug regimen out to 96 weeks. Administration of long-acting parenteral medication removes the daily dosing burden for patients and the LATTE-2 results showed that long-acting cabotegravir and rilpivirine maintained viral suppression, with no virologic failures in the four-week dosing group. We look forward to results from our phase 3 program with long-acting cabotegravir and rilpivirine in 2018,” stated John C Pottage Jr, Chief Scientific and Medical Officer for ViiV Healthcare in the press release.

Look for an interview with Peter Williams, PhD, Development Team Leader in Global Public Health at Johnson & Johnson, Belgium on the LATTE-2 study on ContagionLive.com.