CROI: Doubling Up on Protease Inhibitor Helps Control Viral Infection in HIV Patients in Virologic Failure
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CROI: Doubling Up on Protease Inhibitor Helps Control Viral Infection in HIV Patients in Virologic Failure

By Ed Susman

SAN FRANCISCO, CA -- February 13, 2004 -- Adding two protease inhibitor drugs to the anti-HIV regimen of patients in virologic failure appears to provide a better control of viral infection, according to a poster presentation made February 9th at the 11th Annual Conference on Retroviruses and Opportunistic Infections.

Researchers compared 1 protease inhibitor with regimens containing 2 of the antiretroviral drugs among patients who had been on previous regimens containing a protease inhibitor that was unable to control viral replication.

"In patients with virologic failure on their first protease inhibitor, the non-nucleoside reverse transcriptase inhibitor [NNRTI]-containing salvage regimens with 2 protease inhibitors provided better virologic and immunologic responses than the regimens with 1 protease inhibitor," reported Jay Kostman, MD, Chief, Division of Infectious Diseases, Presbyterian Medical Center, Philadelphia, Pennsylvania.

Dr. Kostman described results of the Community Programs for Clinical Research on AIDS (CPCRA) Study 057, a multicenter, randomized trial conducted between April 1998 and June 2000. The CPCRA is a community-based clinical trials network aimed at informing healthcare providers and people living with HIV on the most appropriate use of available HIV therapies in diverse populations across the spectrum of HIV diseases.

The trial recruited 68 patients to receive either a single protease inhibitor plus a non-NNRTI plus nucleoside reverse transcriptase inhibitors or to receive the same background treatment in addition to 2 protease inhibitors. The prescribed NNRTI were efavirenz and nevirapine. The patients had experienced virologic failure while on nelfinavir or indinavir regimens.

A year after the change in therapy, patients who received the double protease inhibitor regimen achieved an average decrease in HIV RNA of 1.41 log10 compared with an average decrease of 0.59 log10 in those on the new regimen with 1 protease inhibitor (P = .05).

The CD4-positive cell counts increased an average of 68 cells/mcL from baseline in those on the 2 protease inhibitors, but decreased by 11 cells/mcL from baseline if they were on the regimen with 1 protease inhibitor (P = .04).

The researchers concluded that patients with virologic failure on their first PI have better virologic and immunologic responses when they receive a NNRTI-containing salvage regimen with 2 protease inhibitors rather than with 1 protease inhibitor.

The trial was funded by the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.

[Study title: A Randomized Trial of 1 or 2 Protease Inhibitors in Combination with a Non-nucleoside Reverse Transcriptase Inhibitor and Background Therapy in Patients with Virologic Failure on an Initial Protease-inhibitor Containing Regimen. Abstract 548]

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