.jpg "im pro pipeline")
While CAB/RPV has been approved for use by people already on successful antiretroviral therapy, some people are on suboptimal therapy and have few treatment options remaining. Injectable Lenacapavir With Six-Month Dosing
“CAB/rilpivirine is coming, and we’re going to be injecting people’s butts with this stuff,” Wohl said.
Im pro pipeline how to#
“I feel like we’re a little ill-prepared right now, most of us, for introducing this into the clinic, and need as much data as possible” on practical questions such as how to handle late or missed doses, he said.īut, regardless, injectable therapy is here, and it’s on providers to adjust to that reality. While every-eight-week dosing of CAB/RPV appears promising, Wohl noted to TheBodyPro that his clinic is still adjusting to the nuances of administering periodic IM injections instead of writing prescriptions for oral medications. (That person was in the Q8W arm.) Other severe drug-related events were rare. Injection-site reactions remained common, though Jaeger noted in his presentation that they grew less frequent during the course of the study, and only one person dropped out of the study due to that side effect between weeks 48 and 96. Only one person was determined to have experienced virologic failure between weeks 48 and 96 (they were in the Q8W arm), but a retrospective data review indicated that person had a baseline resistance mutation to rilpivirine.ĭrug-related adverse events were similar between the two study arms and did not change much from week 48 to week 96. Most participants who failed to meet virologic suppression criteria had no viral-load data available (usually due to study discontinuation) virologic non-response rates were 2% in the Q8W arm and less than 1% in the Q4W arm. Prior 48-week ATLAS-2M findings indicated likely non-inferiority for the Q8W injections, and the new 96-week snapshot data continue to bear that out: In an intention-to-treat efficacy analysis, 91% of participants in the Q8W arm had a viral load below 50 copies/mL, compared to just over 90% in the Q4W arm. The findings were presented by Hans Jaeger, M.D., of MVZ München am Goetheplatz.
Im pro pipeline trial#
CROI 2021 brought 96-week data from ATLAS-2M, a phase 3b randomized (but open-label) trial comparing CAB/RPV IM injections given every four weeks (Q4W) to every eight weeks (Q8W). as a monthly injection, but an every-two-months dose may be close on its heels.
Related: David Alain Wohl, M.D., on CROI 2021 research regarding long-acting antiretrovirals for HIV treatment The Long-Acting HIV Treatment Pipeline: CROI 2021 Updates Injectable Cabotegravir/Rilpivirine Every Two MonthsĬAB/RPV was approved in the U.S. And at the 28th Conference on Retroviruses and Opportunistic Infections (CROI 2021) in early March, we got a lot of new data on additional choices in development for long-acting HIV treatment and prevention. “I’m big into people having choice,” Wohl said. And if it wasn’t for the pandemic, there’d be a lot more buzz about this.”īut, he added, “I don’t think the majority of people will want to take an IM injection.” For those individuals, offering additional administration methods and dosing alternatives may be key to further reducing HIV transmission. “Right now, we’re rolling out every-monthly injection. “I’ve been a booster of long-acting injectables as an option,” said David Alain Wohl, M.D., a professor of medicine at the University of North Carolina-Chapel Hill.
0 kommentar(er)
