Nelfinavir Combination Therapy: Ten-Month Report

Six-month results from a clinical trial of the triple combination of nelfinavir (VIRACEPT(R)) plus AZT plus 3TC (in volunteers with little or no prior antiretroviral use) were presented in January at the Fourth Conference on Retroviruses and Opportunistic Infections (see AIDS TREATMENT NEWS #265, February 21, 1997). Recently, 10-month results (for those volunteers in the ongoing trial with at least ten months experience) were presented at the International Conference on AIDS Research (ICAR), in Atlanta, by Sharon Chapman, Ph.D. from Agouron Pharmaceuticals, Inc.

In the arm which included the approved nelfinavir dose of 750 mg three times a day, 87% of 74 volunteers with ten months of the combination treatment had viral load below the cutoff used of 1200 copies/ml (84% of these 74 volunteers were below 500 copies); CD4 counts increased by an average of 173. Of 12 of these volunteers who started the trial with a CD4 count under 50 (and an average viral load of 294,000 copies), 11 had a viral load below the cutoff.

In a separate study reported at the ICAR conference, researchers studied the same treatment combination in 12 antiretroviral-naive volunteers for one year, with intensive immunological monitoring. They reported durable suppression of virus in 11 of the 12 -- and resolution or improvement in a number of HIV-related symptoms. One volunteer who could not tolerate the regimen was switched successfully to d4T, 3TC, and indinavir; another, who had advanced HIV, had a virologic breakthrough but seemed to respond to a combination of ritonavir and saquinavir. This study also found a good antiviral response in lymph tissue and in semen.