Promising Results for Two-Drug, Long-Acting Injectable HIV Regimen

 No virologic non-responders were identified in the 4-week group while just 4% were identified in the 8-week group
No virologic non-responders were identified in the 4-week group while just 4% were identified in the 8-week group

A two-drug, long-acting injectable regimen of HIV medications has demonstrated efficacy in maintaining HIV-1 viral suppression throughout almost two years of treatment. The results come from the ongoing LATTE-2 trial and were presented today at the 9th International AIDS Society (IAS) Conference on HIV Science, in Paris.

This Phase 2b trial assessed HIV-1 viral suppression with rilpivirine (Janssen) and cabotegravir (ViiV Healthcare) given together every 4 or 8 weeks. Participating individuals had a plasma HIV-1 RNA, <50 c/mL during a 20-week Induction Period with daily oral cabotegravir 30mg plus abacavir/lamivudine 600mg/300mg. Following induction they were randomized 2:2:1 to intramuscular injections every 4 weeks (long-acting cabotegravir 400mg plus rilpivirine 600mg; two 2-mL injections), or every 8 weeks (long-acting cabotegravir 600mg plus rilpivirine 900mg; two 3-mL injections), or to continue receiving three-drug, oral ART in the Maintenance Period.

Results showed that for those who received injections every 8 weeks, 94% (n=108) achieved viral suppression. In addition, virologic response was achieved by 87% (n=100) of patients who received injections every 4 weeks versus 84% (n=47) of patients in the oral ART group. No virologic non-responders were identified in the 4-week injection group while just 5 (n=4%) were identified in the 8-week group. 

Related Articles

“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 MD, CSO, Johnson & Johnson.

Injection site reactions (ISRs) were common for both the 4-week and 8-week group, at 97% and 96%, respectively; however they were considered mild or moderate in severity. The most common non-ISR events were nasopharyngitis (4-week group: 34%; 8-week group: 30%; oral cabotegravir plus abacavir/lamivudine group: 39%), diarrhea (4-week group: 28%; 8-week group: 23%; oral cabotegravir plus abacavir/lamivudine group: 20%), and headache (4-week group: 23%; 8-week group: 25%; oral cabotegravir plus abacavir/lamivudine group: 25%). 

Full findings from the LATTE-2 study are published in The Lancet

For more information visit TheLancet.com.