ViiV Healthcare injectable doublet HIV therapy shows long-term benefit

Five-year data from the Phase 2b LATTE-2 study and 12-month data from the Phase 2b POLAR rollover study showed sustained benefits from ViiV Healthcare's doublet injectable HIV regimen of cabotegravir and rilpivirine, potentially reducing the number of treatment days to six from 365 while maintaining viral suppression. The results were presented at the IDWeek conference.

In LATTE-2, 88% (n=101/115) of participants receiving the two-month regimen and 74% (n=85/115) receiving the monthly regimen remained virally suppressed, although both lagged the proportion [93% (n=41/44)] of patients in the oral three-drug therapy comparator arm who remained virally suppressed at year five. 19% (n=44/230) of the patients receiving the injectable regimens were not virally suppressed at year five, but 40 had no virologic data available for review since they left the study prior to the time point.

In POLAR, 97 virologically suppressed HIV-positive patients, including participants who rolled over from LATTE after completing six years of the study, were enrolled. At the time of rollover, subjects on daily oral cabotegravir and rilpivirine were offered the option to switch to the long-acting injectable regimen. 93% (n=90/97) chose to do so. At month 12, 88% (n=79/90) preferred the injectable therapy citing increased convenience and reduced frequency of administration.

On the safety front, the injectable regimen was generally well-tolerated. The rate of serious adverse events as 6% (n=5/90), but only one was considered drug-related. 78% (n=70/90) reported injection site reactions (ISRs) at some point in the 12-month study period. Out of a total of 1,534 injections, 463 (30%) were reported as ISRs, all mild or moderate averaging three days in duration. Aside from ISRs, the most common adverse events (AEs) were nasopharyngitis (11%), upper respiratory tract infections (11%), diarrhea (10%), and pyrexia (10%). Two participants (2%) experienced AEs that led to withdrawal.

• The long-acting regimen was approved in Canada in March. ViiV's U.S. marketing application is currently under FDA review. In Europe, the advisory group CHMP recently issued a positive opinion backing approval which typically means a nod there.
• ViiV Healthcare is the HIV-focuses joint venture between GlaxoSmithKline (NYSE:GSK), Pfizer (NYSE:PFE) and Shionogi (OTCPK:SGIOY).

https://seekingalpha.com/news/3624749-viiv-healthcare-injectable-doublet-hiv-therapy-shows-long-term-benefit