Phase IIa study show Reverset potentially reduces HIV viral load.

2004 DEC 1 - (NewsRx.com & NewsRx.net) -- Incyte Corporation (Nasdaq:INCY) announced that patients with HIV who were failing antiretroviral therapy showed a reduction in viral load following treatment with Reverset, a nucleoside-analogue reverse transcriptase inhibitor (NRTI), according to the results from a fourth cohort of 10 treatment-experienced patients in a phase IIa clinical trial conducted jointly by Incyte and Pharmasset, Inc.

Seven of the eight patients treated with Reverset demonstrated a clinically significant reduction in viral load. The results were presented by Robert Murphy, MD, professor of medicine, Northwestern University, in an oral presentation at the 44th International Conference on Antimicrobial Agents and Chemotherapy (ICAAC).

Initial results from this study, known as Study 202, which involved 30 treatment-naive and 10 treatment-experienced HIV patients, were presented at the XV International AIDS Conference in Bangkok earlier in 2004. The data presented at ICAAC included additional analysis of findings related to several patient sub-groups within the population of 10 treatment-experienced subjects.

In the 10-day study involving the 10 treatment-experienced patients, eight were treated with a 200 mg once-a-day dose of Reverset and two received placebo with their regimen. The findings from within this sub-group suggest that Reverset may be an effective therapeutic option for patients infected with HIV containing specific viral mutations often seen in treatment with currently available NRTI therapies.

"Resistance to therapy remains an ongoing problem for HIV patients and the physicians who treat them. These findings indicate that Reverset may have important applications for the population of people living with HIV who develop resistance to other antiretroviral therapies. Incyte is currently enrolling a phase IIb trial, known as Study 203, involving 180 treatment-experienced HIV patients who will be treated with Reverset in combination with other antiviral agents," stated Murphy.

In addition to the overall mean reduction in viral load of 0.8 log copies/mL among the eight Reverset-treated patients, analysis of the study findings presented by Murphy also showed, for the first time, that six subjects receiving or failing therapy with 3TC (Epivir), and five subjects receiving or failing treatment with tenofovir (Viread) achieved a mean viral load reduction of at least 0.7 log copies/mL following treatment with Reverset.

Additionally, four of the eight ...