Injectable HIV Treatment Effectively Suppresses Virus

An injectable HIV therapy was as effective as an oral regimen at maintaining viral suppression, according to a recent study.

The ongoing randomized phase 2b, open label study included 286 treatment-naïve adults with HIV-1 who initially received once-daily oral cabotegravir 30 mg plus abacavir–lamivudine 600-300 mg. After a 20-week induction period, patients who achieved viral suppression were randomly assigned to receive intramuscular long-acting cabotegravir plus rilpivirine at 4-week intervals (n=115) or 8-week intervals (n=115) or to continue receiving oral cabotegravir plus rilpivirine (n=56). Viral suppression after 32 weeks of treatment, virological failures, and safety events through 96 weeks were assessed as the primary endpoints.
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After 32 weeks of treatment, viral suppression was maintained in 51 (91%) patients in the oral treatment group, 108 (94%) patients in the 4-week intramuscular regimen treatment group, and 109 (95%) patients in the 8-week intramuscular regimen treatment group. Both intramuscular long-acting regimens met the criteria for comparability in viral suppression compared with the oral regimen.

After 96 weeks, viral suppression was maintained in 47 patients (84%) receiving oral treatment, 100 (87%) patients receiving 4-week intramuscular treatment, and 108 (94%) patients receiving 8-week intramuscular treatment.

Two patients in the 8-week treatment group and 1 patient in the oral treatment group experienced virological failure. Injection-site pain was reported frequently by participants who received intramuscular regimens, but injection-site reactions were mostly mild or moderate and rarely resulted in discontinuation.

While serious adverse events occurred in 22 (10%) out of 230 patients who received intramuscular treatment and 7 (13%) out of the 56 patients who received oral treatment, none of the adverse events were related to the study drugs.  

“The two-drug combination of all-injectable, long-acting cabotegravir plus rilpivirine every 4 weeks or every 8 weeks was as effective as daily three-drug oral therapy at maintaining HIV-1 viral suppression through 96 weeks and was well accepted and tolerated,” the researchers concluded.

—Melissa Weiss

Reference:

Margolis DA, Gonzalez-Garcia J, Stellbrink HJ, et al. Long-acting intramuscular cabotegravir and rilpivirine in adults with HIV-1 infection (LATTE-2): 96-week results of a randomised, open-label, phase 2b, non-inferiority trial [published online July 24, 2017]. Lancet. http://dx.doi.org/10.1016/S0140-6736(17)31917-7.