Data Published in The Lancet Shows High Efficacy at 96 Weeks for First Investigational Two-Drug, Long-Acting Injectable HIV Regimen

Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) announced that a regimen of two investigational long-acting, injectable formulations of HIV medicines -- Janssen's rilpivirine and ViiV Healthcare's cabotegravir -- given together every 4 or 8 weeks was as effective as 3-drug oral antiretroviral therapy (ART) at maintaining HIV-1 viral suppression through 96 weeks (HIV-1 RNA
Viral suppression was achieved in 94 percent of those (n=108) receiving injections every eight weeks, warranting further investigation. Virologic response was also achieved by 87 percent (n=100) of those receiving injections every four weeks versus 84 percent (n=47) receiving oral ART therapy. In an unprecedented outcome, no virologic non-responders to the long-acting regimen were observed in the four-week group, as determined by the stringent FDA snapshot algorithm. Few virologic non-responders were seen in the eight-weekly group (n=5 [4%]). These results highlighted that the two-drug, long-acting regimen offered durability of virologic response throughout almost 2 years of treatment.

"Results published in The Lancet strengthen the evidence that a two-drug, long-acting regimen may offer an effective and acceptable alternative for people who have achieved viral suppression but struggle with daily, oral regimens to control their HIV," said Paul Stoffels M.D., Chief Scientific Officer, Johnson & Johnson. "Non-adherence to treatment remains a challenge for many people living with HIV and one of the main drivers of resistance to HIV medicines. Our hope is to make HIV treatment manageable for all by developing innovative solutions like long-acting regimens."

In LATTE-2, patients with HIV-1 viral suppression on oral medication (cabotegravir plus abacavir/lamivudine) were randomized 2:2:1 to long-acting injections every four or eight weeks, or to daily oral cabotegravir taken with abacavir and lamivudine.

High satisfaction was reported in the study by those receiving the two-drug, long-acting regimen, which suggests it may provide a preferred alternative for many people living with HIV who may not wish to consider taking life-long oral therapy. The data are based on the observed case data set of subjects who completed questionnaires at week 48 and week 96.

The two-drug, long-acting regimen was generally well tolerated, with no drug-related serious adverse events and few adverse event-related withdrawals. While injection-site reactions (ISRs) were common (four-weekly group, 97% of patients; eight-weekly group, 96% of patients), they were transient in nature, and mild or moderate in severity. The long-term acceptability of administering chronic intramuscular injections to patients was also demonstrated in LATTE-2, with very few withdrawals resulting from ISRs (two patients [
The most commonly reported non-ISR adverse events were nasopharyngitis (four-weekly group, 34%; eight-weekly group, 30%; oral cabotegravir plus abacavir/lamivudine groups, 39%), diarrhea (four-weekly group, 28%; eight-weekly group, 23%; oral cabotegravir plus abacavir/lamivudine group, 20%), and headache (four-weekly group, 23%; eight-weekly group, 25%; oral cabotegravir plus abacavir/lamivudine group, 25%).

Two global Phase 3 switch studies, FLAIR (First Long-Acting Injectable Regimen) and ATLAS (Antiretroviral Therapy as Long-Acting Suppression), are currently examining the safety and efficacy of four weekly dosing with the two-drug, injectable regimen.

For more information on the clinical trials, visit www.clinicaltrials.gov