HealthDay News – In patients with multidrug-resistant HIV-1 infection with limited treatment options, the reduction in HIV-1 RNA levels in patients who received fostemsavir was significantly higher in the first eight days compared to placebo. This is according to a study published in the study March 26th issue of the New England Journal of Medicine.
Michael Kozal, MD, of Yale University Medical School in New Haven, Connecticut, and colleagues enrolled patients with multidrug-resistant HIV-1 infection in two cohorts. In the first case, 272 patients who had the opportunity to use at least one fully active, approved antiretroviral drug in at least one but no more than two antiretroviral classes were randomly added to either fostemsavir or placebo to their failed regimen for eight days, followed by open-label fostemsavir. In the second cohort, 99 patients with no remaining antiretroviral options were initiated on open-label fostemsavir.
The researchers found that the mean decreases in HIV-1 RNA levels in the fostemsavir and placebo groups on day 8 were 0.79 and 0.17 log10 copies / ml, respectively. At week 48, a virologic response had occurred in 54 and 38 percent of patients in the randomized and non-randomized cohorts, respectively; The mean increase in CD4 + T cell counts was 139 and 64 cells / mm³, respectively. Adverse events led to discontinuation of fostemsavir in 7 percent of patients.
“Fostemsavir has a novel mechanism of action with no in vitro cross-resistance to currently available classes of antiretroviral drugs, has a favorable drug-drug interaction profile, and has demonstrated both immunological and virological responses,” the authors write.
The study was funded by Bristol-Myers Squibb and GlaxoSmithKline / ViiV Healthcare, the company that makes fostemsavir.
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Antiretroviral Drugs for HIV / AIDS