One time medication for one year is effective, and the early clinical results of AIDS prevention therapy are positive
Mar 11, 2021
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Today, MSD announced that it had positive results in a phase 1 clinical trial with the study of the nrtti, islatravir (aka mk-8591). Three different doses of islatravir were used as subcutaneous slow release implants (implant), which can keep the drug concentration higher than the predetermined pharmacokinetic (PK) threshold within 12 weeks after implantation. The dose of 56 mg of ilatravir is expected to keep the drug concentration above the threshold for more than one year. Based on this positive result, MSD will launch phase 2 clinical trials to further explore the potential of the subcutaneous implant of islatravir as a long-term pre exposure prevention (PREP) therapy. It may provide up to 12 months of protection with just one drug use.
With the emergence of cocktail therapy, AIDS has changed from an unheard of disease to a chronic disease that can be controlled by drugs. But in some countries, the incidence rate of AIDS is still high. Pre exposure prevention therapy aims to prevent people at risk of HIV-1 infection and reduce their risk of HIV-1 infection. However, the current prevention therapy needs to be taken daily by high-risk groups, and low compliance will increase their risk of infection.
Islatravir is an innovative nrtti developed by moshadong. Preclinical studies show that it can inhibit the function of HIV retroenzyme through many mechanisms. Its mechanism is different from the approved anti HIV therapy and traditional nucleoside reverse transcriptase inhibitor (NRTIs). Currently, mosartan has been tested in several clinical trials as a single drug prep therapy and combined with other antiviral therapy for HIV infection.
In this double-blind, placebo-controlled phase 1 clinical trial, 24 healthy participants implanted an implant with different doses of islatravir in the upper arm, which can release the drug slowly in the body, thus achieving the long-term maintenance of drug treatment concentration. After 12 weeks of implantation, the implant was removed and participants were then assessed for an 8-week period.
The results showed that the concentration of islatravir was maintained above the antiviral level in 12 weeks. The higher dose (52 mg and 56 mg) of islatravir can maintain the drug concentration above the threshold after the implant is removed until the end of the study. Based on these results and previous assessments of the islatravir implant, the researchers expect the administration to maintain drug concentrations above the target PK threshold for at least one year.
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