Maraviroc Reduces HIV Viral Load In Treatment-Naive Patients
Pfizer has reported results of a phase III study of investigational HIV medication, maraviroc, for treatment-naive adult patients infected with CCR5-tropic HIV-1.
The data was reported by Pfizer at the International Aids Society conference in Sydney, Australia. "Pfizer's results indicate reduction in viral load and increased CD4 counts," said Christos Petropoulos, Monogram Chief Scientific Officer. "In addition, the trial showed a safety profile that was better than in the control arm. This further supports the safety of maraviroc as a new treatment option for treatment-experienced patients."
Monogram's Trofile Assay has been used to select patients for all of the drug's clinical trials.
Pfizer has previously reported 24 week data from its phase III trials of maraviroc in treatment-experienced patients and has recently announced that the 48 week analysis has confirmed these 24 week findings.
An NDA is pending with the U.S. Food and Drug Administration and an approvable letter has been received from the F.D.A. in respect of the use of maraviroc in treatment- experienced patients. The data reported today by Pfizer is in respect of a potential new indication in treatment-naive patients that would be subject to a separate FDA submission.