Merck's ISENTRESS® Tablets In Combination With Other Anti HIV Medicines Maintained Reductions In HIV 1 Viral Load And Increased CD4 Cell Counts
In October, the U.S. Food and Drug Administration (FDA) granted ISENTRESS accelerated approval for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-experienced adult patients with evidence of viral replication with HIV-1 strains resistant to multiple antiretroviral agents. The approval was based on analyses of viral load reductions and CD4 cell count increases from baseline through 24 weeks in two phase III studies of ISENTRESS. This week, 48-week data from those same studies were presented at the 15th Conference on Retroviruses and Opportunistic Infections (CROI).
The use of other active agents with ISENTRESS is associated with a greater likelihood of treatment response. The safety and efficacy of ISENTRESS have not been established in treatment-naïve adult patients or pediatric patients. There are no study results demonstrating the effect of ISENTRESS on clinical progression of HIV-1 infection.
"The 48-week efficacy results are consistent with what we observed at Week 24," said Roy Steigbigel M.D., professor of medicine, pathology, microbiology and pharmacology, State University of New York at Stony Brook and lead study investigator for one of the studies.
ISENTRESS studied in nearly 700 patients
The data presented this week are from Week 48 results from two identical ongoing multi-center, double-blind, randomized, placebo-controlled Phase III studies (BENCHMRK-1 and BENCHMRK-2) that compare ISENTRESS in combination with optimized background therapy (OBT) to placebo plus OBT. The primary endpoint of this ongoing study is the percentage of patients in each study arm that achieve HIV RNA viral levels less than 400 copies/mL at Week 16. Patients in BENCHMRK-1 were enrolled in Europe, Asia/Pacific and Peru. The mean baseline viral load was 4.6 log10 copies/mL for the regimen with ISENTRESS and 4.5 log10 copies/mL for the placebo regimen, respectively. The median baseline CD4 cell counts were 140 cells/mm3 for the regimen with ISENTRESS and 105 cells/mm3 for the placebo regimen, respectively. Patients in BENCHMRK-2 were enrolled in North and South America. The mean baseline viral load was 4.7 log10 copies/mL for both the regimen with ISENTRESS and the placebo regimen, respectively. The median baseline CD4 cell counts were 102 cells/mm3 for the regimen with ISENTRESS and 132 cells/mm3 for the placebo regimen, respectively.
Patients who entered the study experienced treatment failure on prior antiretroviral therapies and were infected with HIV resistant to one or more drugs in each of three oral classes of ARTs (NRTIs, NNRTIs and PIs).
Patients received ISENTRESS 400 mg or placebo, each dosed orally twice daily in combination with OBT. OBT was determined based on patients' prior treatment history and results from HIV resistance testing. In order to allow for the best possible treatment regimen to be constructed for each patient, darunavir and tipranavir, which were investigational medicines in many countries at the time of this study, were allowed to be included in OBT.
Suppression of viral load and increases in CD4 cell counts observed through 48 weeks In one of these studies, called BENCHMRK-1, at 48 weeks, ISENTRESS plus OBT maintained suppression of HIV RNA levels below 400 copies/mL in 74 percent of patients (170 out of 231) compared to 36 percent of patients (43 out of 118) receiving placebo plus OBT; p
Merck ? comprimate de ISENTRESS în asociere cu alte medicamente anti-HIV, menþinut în reduceri de HIV 1 încãrcãturii virale ºi creºterea numãrului de celule CD4 - Merck's ISENTRESS® Tablets In Combination With Other Anti HIV Medicines Maintained Reductions In HIV 1 Viral Load And Increased CD4 Cell Counts - articole medicale engleza - startsanatate