Incyte drug as potential to reduce viral load

Patients with human immunodeficiency virus (HIV) who were treated for 10 days with Incyte's Reverset, a nucleoside-analogue reverse transcriptase inhibitor (NRTI) that is being developed as a once-a-day oral therapy for use in combination with other antiretroviral drugs, showed a reduction in viral load according to the results of a Phase II clinical trial.

Reverset was well-tolerated at all doses studied. The study, referred to as Study 202, involved 30 treatment-naive and 10 treatment-experienced HIV patients and demonstrated a clinically significant reduction in viral load for all treatment-naive patients and 7 of 8 patients who had failed previous therapies.

Based on the study results presented by Dr Robert Murphy, professor of medicine, Northwestern University, and announced by Incyte Corporation and Pharmasset, Inc., Incyte's strategic collaborative and licensing partner for Reverset, the mean reduction in viral load among the treatment-naive patients who received either the 50 mg, 100 mg or 200 mg once daily dose of Reverset ranged from 1.67 log10 copies/mL to 1.77 log10 copies/mL. The mean reduction in viral load among the 8 treatment-experienced patients dosed with Reverset was 0.8 log10 copies/mL. Among patients receiving 200 mg of Reverset, 7 of 8 (87.5%) treatment-naive patients and 4 of 8 (50%) treatment-experienced patients achieved viral loads less than 400 copies/mL following 10 days of dosing. Reverset was well-tolerated in all patients with no significant adverse effects observed. No new resistance mutations developed during the 10 days of treatment with Reverset.

'Reverset was very well-tolerated and demonstrated potent antiviral effects both as monotherapy in treatment-naive patients and when added to a failing regimen in treatment-experienced subjects. The results of this Phase IIa study are encouraging and compare favourably with the results obtained with other currently approved NRTIs,' stated Dr Murphy. 'Because resistance to other antiretroviral therapies remains an ongoing problem for many men and women living with HIV, we look forward to further progressing the development of Reverset, and completing and reporting the results from a second Phase II trial, Study 203, which is expected to involve 180 treat-ment-experienced HIV patients.'

Treatment-experienced subjects enrolled in Study 202 had previously failed a mean of 5.5 regimens and half these subjects had four or more thymidine analogue mutations at the initiation of Reverset treatment. Reverset demonstrated equal effectiveness in patients receiving and failing regimens that included 3TC (Epivir) and/or tenofovir (Viread), two commonly prescribed NRTI therapies. The most common adverse experiences in the study were cold symptoms (Reverset 46% versus placebo 33%), headache (Reverset 33% versus placebo 33%), and tiredness (Reverset 17% versus placebo 17%).