In addition,
Mk-8527 goes phase 3:
KIGALI-A new prolonged action option. Consequently, presented at the last IAS congress held in Rwanda, is added to the panoply of available tools: the MK-8527, an oral tablet-taking monthly for HIV prevention, a study of which has shown that it was well tolerated in adults. Consequently, This medication is currently going on phase 3 of clinical trials in Africa.
Towards a phase III
Long-lasting options for pre-exhibition prophylaxis (PREP) of HIV-1 are necessary. For example, As such. For example, the MK-8527 of the Merck laboratory is a new oral nucleosidic inhibitor for transcriptase transcriptase (integration), with pharmacokinetic properties allowing a monthly socket. In addition, A phase 2 study analyzed the safety. Therefore, pharmacokinetics of this monthly molecule in adults at low risk of exposure to HIV.
In this one. Nevertheless, American and African researchers have studied the safety and pharmacokinetics mk-8527 goes phase 3 of the MK-8527 Oral QM in adults with a low risk of exposure to HIV-1.
In a multicenter double-blind study (NCT06045507). adults aged 18 to 65 years HIV negative were randomized according to a report 2: 2: 2: 1 to receive MK-8527 (3, 6 or 12 mg) or a placebo QM for 6 months. Adverse events and laboratory tests were monitored for 8 weeks after the last dose. The MK-8527 in the plasma was measured for all participants. The MK-8527-Triphosphate (TP). Additionally, the active form, in the mononuclear cells of peripheral blood (PBMC) was measured in a subgroup of participants.
A total of 350 participants were recruited (58.3 % women; 28-year-old median age; 51.4 % whites, 41.4 % black/African-American, 2.3 % Asians) and received at least one dose of the active drug under study; 328 (93.7 %) received the six doses. The incidence of undesirable events was similar for the mk-8527 goes phase 3 MK-8527 and the placebo. No clinically significant change has been observed in laboratory tests. including the total number of CD4 T lymphocytes and T lymphocytes. The pharmacokinetic parameters of the MK-8527 and the MK-8527-TP were proportional to the dose. The details of the study results are accessible here.
Scientists have concluded that the MK-8527 tolerance. with a safety profile similar to that of placebo in adults with a low risk of exposure to HIV-1. The pharmacokinetics of the MK-8527. the MK-8527-TP supports the continuation of the development of the MK-8527 Oral QM for the prep.
Dr. Kenneth Mayer declared potential links of interest:
-
Bours the research the Merk & CO, ViG Healthcare it Gilad SCIENCES;
-
Participation in scientific advice for Merck & Co, VIIV Healthcare and Gilead Sciences
mk-8527 goes phase 3
The financing of the study was provided by Merck Sharp & Dohme. Firm employees were involved in the study protocol, data analysis and the presentation of the results.
Follow Medscape in French on Bluesky , Facebook , Instagram , Linkedin , Youtube .
Register for newsletters DE MEDSCAPE: Select your choices
Mk-8527 goes phase 3
Further reading: 13 deaths after polarian alcohol poisoning – “Sun-Tattoos”, “Burn-Lines”, “Tan-lines”: Where do these dangerous tanning trends come from? – 5 key points on Adaflex – In Toulouse, treat parents to protect newborns – – The Fluad vaccine available in France.
