(adefovir dipivoxil) is a new drug from Gilead Sciences.
Note to Editors: PREVEON
and VISTIDE are registered trademarks of Gilead Sciences, Inc.
Results indicate that treatment with 60 mg monotherapy provides significant anti-HIV activity compared to placebo in treatment-naive patients, and that combination regimens comparing 60 mg and 120 mg doses of PREVEON
show similar antiviral effects in treatment-experienced patients.
During HIV clinical testing, the most common side effects reported with PREVEON
have been dose-related gastrointestinal effects, including nausea and loss of appetite.
Results from recently unblinded studies indicate that treatment with 60 mg monotherapy provides statistically significant anti-HIV activity compared to placebo in treatment-naive patients, and that combination regimens including 60 mg or 120 mg doses of PREVEON
have similar efficacy in treatment-experienced patients.
Two development-stage products, Gilead's PREVEON
for the potential treatment of HIV and GS 4104 for the potential treatment of viral influenza, will be submitted in 1999 to the U.
These studies (GS 411, GS 417 and GS 420 and CPCRA 039, respectively) were designed to assess the safety and efficacy of 120 mg and 60 mg doses of PREVEON
, an experimental, once-a-day oral medication for the treatment of HIV.
Gilead Sciences Provides Update On PREVEON
Clinical Program for the Treatment of HIV; PREVEON
Profile to be Highlighted in Five Oral (BW0023 07:29)
is being tested in a variety of Phase II/III clinical trials in North America, Europe and Australia and is available in the United States through an Expanded Access Program for patients with limited treatment options.
These results, from Study 408, plus additional data on the activity, safety and resistance profile of PREVEON
, were presented at a Satellite Symposium during the 12th World AIDS Conference in Geneva, Switzerland.
These placebo-controlled data, collected from 142 patients enrolled in a Phase II/III clinical trial (Study 408), also demonstrate that once-daily treatment with PREVEON
for 24 weeks was not associated with the emergence of the adefovir-associated resistance mutations (K65R or K70E) identified in vitro.
The program makes PREVEON
available free of charge to HIV infected adults in the United States who have failed treatment with at least two nucleoside analog reverse transcriptase inhibitors and one protease inhibitor.