Health
PrEP implants may protect against HIV for 1 year
Pharmacokinetic data show that implants that elute the antiretroviral drug islatravir can protect people at risk of HIV infection for at least a year and position it as a potential form of pre-exposure prophylaxis (PrEP). The researchers reported that they did.
According to Randolph Matthews, MD, and PhD, in trials of transplanting three different doses of islatravir into people at low risk of HIV infection, blood levels of islatravir appear to be sufficient to protect against infection at week 12. It was well above the level. Senior Scientist at Merck in Kenilworth, NJ.
The maximum dose – 56 mg – was predicted to provide adequate islatravir blood levels for almost all individuals for at least 52 weeks, he said in a virtual oral presentation. Conference on Retroviruses and Opportunistic Infections (CROI)..
This is the second virtual CROI and was forced into zoom format due to the COVID-19 pandemic. This conference was one of the first to be virtualized in 2020. In fact, some prospective attendees had already arrived when the face-to-face meeting was cancelled.
“Next-generation radiation-impermeable islatravir-eluting implants provide drug release that is predicted to be sufficient for HIV prevention for at least a year,” says Matthews. “Islatravir-eluting implants appear to be well tolerated, and the results of this study support further studies of these implants in larger, longer-term Phase II trials. PrEP implants are the daily PrEP regimen. It may offer attractive options to individuals who adhere to. It is rewarding. “
In this study, patients were implanted using the Nexplanon applicator, which has been used for many years to implant contraceptives. The implant is immersed in radioactive barium so it can be tracked if it moves.
The implant was placed on the patient’s upper arm and left in place for 12 weeks, at which point the implant was removed and the patient was monitored for an additional 8 weeks. Over that period, drug levels declined with a half-life of about 8 days.
Matthews et al. Enrolled eight individuals in each of the three dose groups of 48, 52, and 56 mg. Another 12 untreated individuals served as controls. Of the 36 patients, 22 reported at least one adverse event. Nothing was serious and there was no need to discontinue treatment due to adverse events. Side effects included redness at the injection site, tenderness and pain, and some itching.
“PrEP doesn’t fit all in one size,” said Richard Coup, MD, Ph.D., Ph.D., National Institute of Allergy and Infectious Diseases, who moderated the press conference Matthews said. “The more opportunities we have, such as monoclonal antibodies, long-acting antiretrovirals, implantables, etc., the better. This has always been a problem for people and populations with any of these modality. It will be.”
Dr. Sharon Hiller, co-moderator of the University of Pittsburgh School of Medicine, said: Today’s MedPage, “Not everyone wants an implant, but many women find it a good way to contraceptive. Islatravir is not the answer, but some It will be another approach that people can use. “
Disclosure
Matthews is an employee of Merck.
Hillier discloses relationships with Becton, Dickinson and Company, Cepheid, Curatek, Dare Biosciences, Hologic, Merck, and Pfizer.
Koup has not disclosed a relationship with the industry.
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