Merck announced new 96-week data from the Phase 3 ONCEMRK study evaluating Isentress HD (raltegravir) given with other antiretroviral agents, for the treatment of HIV-1 infection in children and adults weighing ≥40kg who are treatment-naive or whose virus has been suppressed on an initial regimen of Isentress 400mg twice daily.
Data from Week 48 previously showed that once-daily Isentress HD achieved the primary efficacy endpoint of non-inferiority vs. twice-daily Isentress, demonstrating a similar safety and tolerability profile. The new 96-week data that was presented further validated the safety and efficacy of Isentress HD. The findings were presented at the 9th International Conference on HIV Science (IAS 2017) in Paris, France.
In the multicenter, double-blind, randomized, active comparator-controlled study, 81.5% of patients in the Isentress HD 1200mg group experienced viral suppression <40 copies/mL of HIV-1 RNA vs. 80.1% of patients in the Isentress 400mg group, both in combination with emtricitabine + tenofovir disoproxil fumarate (treatment difference 1.4%, 95% CI: –4.4, 7.3). Compared to baseline, increases in CD4+ T-cell counts were similar between the two treatment arms with an average increase of 261.6 cells/mm3 for Isentress HD vs. 262.2 cells/mm3 for Isentress. Efficacy proved consistent for different patient populations even those with HIV-1 RNA >100,000 copies/mL (high viral load) at baseline.
Less than 1% of patients in both treatment arms had treatment-emergent viral mutations leading to any drug resistance (0.8% Isentress HD vs. 0.8% Isentress) through Week 96. Study authors reported a low rate of treatment discontinuation due to adverse events in both treatment arms (1.3% Isentress HD vs. 2.3% Isentress).
Isentress HD, an integrase inhibitor, was approved by the Food and Drug Administration (FDA) in May 2017. It is given as a once-daily 1200mg oral dose, as two 600mg film-coated tablets.
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