HEALTH NEWS: GSK1265744 rapidly suppresses HIV and appears safe at selected dose

The experimental HIV integrase inhibitor GSK1265744 demonstrated rapid and potent antiviral activity and good tolerability for treatment-naive patients in the LATTE study, according to a report at the 14th European AIDS Conference this week in Brussels.

Integrase inhibitors are among the most well tolerated antiretroviral medications. GSK1265744 (or GSK744 for short), being developed by GlaxoSmithKline, is similar to the recently approved dolutegravir. It is being tested both as a once-daily oral drug and as a long-acting injectable that may allow for once-monthly administration. A recently presented analysis of eight studies showed that it is safe with no notable safety concerns.

The phase 2b LATTE trial started with a 24-week induction phase comparing three oral doses of GSK744 plus two nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) to inform selection of an optimal dose for further development. At week 24 participants with stable viral suppression discontinued NRTIs and switched to a simplified dual maintenance regimen of GSK744 plus oral rilpivirine (Edurant).

At 24 weeks 87% of participants taking GSK744 achieved undetectable viral load (all dose arms combined) compared with 74% of those taking efavirenz in a 'snapshot' analysis. Response was similar with all GSK744 doses (88%, 85% and 87%). There was no significant difference according to NRTI backbone.

Viral load fell rapidly after starting treatment in all GSK744 dose groups. People taking GSK744 achieved viral suppression significantly sooner than those taking efavirenz, with 76% vs 24%, respectively, having undetectable HIV RNA by week 4.

"Oral [GSK744] administered once daily with two NRTIs was associated with a good treatment response," the researchers concluded.

Based on these findings the 30mg GSK744 dose was selected. The maintenance phase of LATTE testing GSK744 plus rilpivirine maintenance therapy is currently underway. Results from that part of the trial will prepare the way for a phase 2b study of combined long-acting injectable formulations of both drugs, which may one day be used as monthly maintenance therapy or pre-exposure prophylaxis (PrEP)

Sent from my BlackBerry wireless device from MTN