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Long-acting injectable combo as good as daily oral regimen for HIV.


A LONG-ACTING INJECTABLE formulation combining two antiretroviral drugs--cabotegravir and rilpivirine--is as effective as a daily oral regimen of cabotegravir plus abacavir and lamivudine, according to interim results from the LATTE-2 trial.

Writing in the July 24 online edition of The Lancet, researchers have reported the 96-week results of the ongoing open-label phase 2b trial involving 286 treatment-naive adults infected with HIV-1.

After a 20-week induction on daily oral cabotegravir plus abacavir-lamivudine, participants were randomized either to intramuscular long-acting cabotegravir plus rilpivirine at 4-week or 8-week intervals, or to continue with the oral therapy.

At 32 weeks, 95% of patients in the 8-week group, 94% of patients in the 4-week group, and 91% of patients in the oral therapy group had maintained viral suppression, defined as plasma HIV-1 RNA less than 50 copies per mL (Lancet. 2017 Jul 24. doi: 10.1016/S0140-6736[17]31917-7).

By week 96, viral suppression was seen in 94% of patients in the 8-week group, 87% of patients in the 4-week group and 84% of patients on oral treatment.

A nonresponse at 96 weeks was seen in five patients in the 8-week group and one patient in the oral therapy group. There were also two patients in the 8-week group and one in the oral treatment group who met the criteria for virologie failure.

"Viral genotyping analysis for the patient in the oral treatment group had no treatment-emergent resistance mutations in the genes encoding viral reverse transcriptase, protease, or integrase," wrote David A. Margolis, MD, from ViiV Healthcare, and his coauthors.

Injection-site pain was the most common adverse event in the injectable groups, experienced by 96%-97% of patients, but most reactions were mild or moderate and lasted a median of 3 days.

There was only one drug-related serious adverse event, which was a migraine that occurred in one patient during the oral induction period. None of the other serious adverse events were deemed to be drug related.

Patients reported high levels of treatment satisfaction across all study groups, and more than 99% of patients in the injectable treatment arms said they would be highly satisfied to continue with the regimen, compared with 78% of patients in the oral treatment arm.

"The acceptability and tolerability of injectable dosing options will be an important component of long-term treatment success, and a high degree of treatment satisfaction will avail this option for patients burdened by life-long daily oral medication compliance," the authors wrote.

However they did note that the study population was mostly white men with a CD4+ cell count at entry of at least 200 cells per mm.

"Therefore, the efficacy, safety, and pharmacokinetic outcomes of long-acting cabotegravir plus rilpivirine in different subpopulations infected with HIV-1 needs further evaluation," the investigators concluded.

The study was funded by ViiV Healthcare and Janssen R&D. Nine authors are employees of ViiV Healthcare and shareholders in GlaxoSmithKline. Nine authors declared funding, grants, and honoraria from a range of pharmaceutical companies including ViiV Healthcare. Two authors are employees and shareholders of GlaxoSmithKline. Two authors are employees of Janssen, and stockholders of Johnson & Johnson, AstraZeneca, or GlaxoSmithKline. One author had no conflicts to disclose.

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Author:Nogrady, Bianca
Publication:Internal Medicine News
Date:Aug 1, 2017
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