LATTE-2 Phase IIB trial of injectable cabotegravir and rilpivirine as a two-drug treatment for patients with HIV-1 infection comparable to a three-drug oral regimen. ViiV HealthCare + Janssen Therapeutics

ViiV Healthcare, announced 96-week data from the LATTE-2 study. LATTE-2 is a phase IIb, open-label study investigating the long-acting, injectable formulations of cabotegravir (ViiV Healthcare) and rilpivirine (Janssen Sciences Ireland UC) as a two-drug treatment for patients with HIV-1 infection who had already achieved viral suppression with a three-drug oral regimen of cabotegravir plus two nucleoside reverse transcriptase inhibitors (NRTIs). The study results were published online in The Lancet and were presented at the annual conference of the International AIDS Society (IAS) in Paris, France. 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 four or eight weeks compared with daily oral dosing with cabotegravir + 2 NRTIs. Following 96 weeks of maintenance treatment in the LATTE-2 study, viral suppression rates (%) for the two-drug regimen dosed every eight weeks (94%) or every four weeks (87%) were comparable to the rate observed in patients continuing with a three-drug oral regimen (84%). Two patients in the eight-week dosing group and one patient in the oral regimen group met protocol-defined virologic failure criteria; neither patient had evidence of resistance at failure. Injection site pain was the most commonly reported injection site reaction (ISR) reported by patients receiving injectable cabotegravir and rilpivirine, most ISRs were mild (84%) or moderate (15%) in severity, with a median symptom duration of three days.

See-"Long-acting intramuscular cabotegravir and rilpivirine in adults with HIV-1 infection (LATTE-2): 96-week results of a randomised, open-label, phase IIb, non-inferiority trial"- Dr David A Margolis,, Juan Gonzalez-Garcia, MD, Prof Hans-J�rgen Stellbrink, MD, Prof Joseph J Eron, MD, et al., Crauwels, PhD, Sandy K Griffith, Pharm D. -Published: 24 July 2017 DOI: http://dx.doi.org/10.1016/S0140-6736(17)31917-7.