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Long-Term Indinavir Treatment Keeps HIV Under Control at 156 Weeks: Presented at IDSA
By Ed Susman
SAN FRANCISCO, CA -- October 11, 2005 -- Most patients who were treated with an antiretroviral regimen that included the protease inhibitor indinavir were able to maintain virologic control for at least 156 weeks.
"Combination antiretroviral therapy with indinavir can yield long-term virologic and immunologic benefits for many treatment-naive asymptomatic patients with early HIV infection," said Deborah McMahon, MD, associate professor of medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.
Dr. McMahon presented the findings in a poster session here on October 8th at the 43rd Annual Meeting of the Infectious Diseases Society of America (IDSA).
In a trial that began in 1997, Dr. McMahon and colleagues placed 199 patients on the following protease inhibitor regimen:
- Indinavir 800 mg TID, taken on an empty stomach with adequate fluids.
- Zidovudine 300 mg every 12 hours.
- Lamivudine 150 mg every 12 hours.
- Stavudine (30 mg or 40 mg depending on body weight) every 12 hours. Could be substituted for zidovudine in case of intolerance.
- Ritonavir 100 mg every 12 hours, added to the regimen after 96 weeks of treatment.
After 24 weeks, 95% of the 174 evaluable patients had achieved viral suppression to an undetectable level using the 400-copy/mL assay, and 91% had achieved undetectable virus on the 50-copy/mL assay.
After 156 weeks of treatment, 114 of the participants (about 57% of the original group) were still on the regimen.
Dr. McMahon said that about 15% of participants left the study due to adverse effects. About 5% of serious adverse events were considered by the investigators to be related to treatment. One person died during the study.
[Presentation title: Long-Term Efficacy, Safety and Tolerability of Indinavir-Based Combination Therapy in Treatment-Naïve Adults With Early HIV Infection. Abstract 798]
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