The results also showed that Isentress dosed at 200mg, 400mg, 600mg orally twice daily in combination with optimized background therapy (OBT) was generally well tolerated in these patients.
Jose Gatell, senior consultant and head, Infectious Diseases and AIDS Units, Clinical Institute of Medicine and Dermatology said: “The findings at 48 weeks are consistent with the 24 week results and what we know to date about the drug’s efficacy and tolerability profile. These results reinforce the drug’s potential as the first in a promising new class of antiretroviral agents.”
Results show that reductions in viral load observed at week 24 in the study were sustained over 48 weeks. After 48 weeks of therapy, 64 to 71% of patients receiving Isentress at the doses studied plus OBT achieved viral load reductions below 400 copies/mL and 46 to 64% of patients receiving Isentress plus OBT achieved viral load reduction to below 50 copies/mL. Increases in CD4 cell counts from baseline were 64 to 110 cells/mm3 for patients receiving Isentress.
The regimen of Isentress (at all doses studied) plus OBT was generally well tolerated and comparable to the tolerability of placebo plus OBT. The most commonly reported study therapy-related side effects (occurring in at least 5% of patients in at least one treatment group) were diarrhea, nausea, fatigue, vomiting, headache, and itching. Five patients discontinued treatment due to adverse experiences.