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Antiretroviral-Experienced Patients Maintain HIV Suppression Through 144 Weeks: Presented at IDSA

By Ed Susman

PHILADELPHIA -- November 1, 2009 -- Highly experienced antiretroviral-treated patients maintained suppression of HIV through 144 weeks when treated with the integrase inhibitor raltegravir, according to research presented here at the 47th Annual Meeting of the Infectious Diseases Society of America (IDSA).

"In patients with limited treatment options, raltegravir in combination with optimised background therapy had potent and durable antiretroviral effects through week 144 and was generally well tolerated," said Bach-Yen Nguyen, MD, Merck Research Laboratories, North Wales, Pennsylvania, speaking at her poster presentation on October 30.

The patients in this study all had HIV mutations that made the virus resistant to 3 classes of antiretroviral medication. After 24 weeks, patients on placebo who were not doing well on optimised background therapy compared with raltegravir were switched to open-label raltegravir 400 mg twice a day. After 48 weeks, about 50% of the patients on raltegravir had suppressed virus to undetectable levels, according to the less-than-50 copies/mL assay.

The 133 patients in this group were then followed through a total of 144 weeks. In the analysis in which noncompleters were considered virologic failures, Dr. Nguyen reported that 43% of the patients still had undetectable virus.

Included in the group on the open-label extension were 45 patients who started in the placebo group. "In the patients in which raltegravir was added to a failing regimen, 32.4% were able to achieve suppression to undetectable levels," Dr. Nguyen reported. "This response is less than that observed in patients who were randomised to raltegravir from the start of the double-blind phase, underscoring the need of starting raltegravir with active optimised background therapy for maximal benefit."

All subjects had been treated with various antiretrovirals for about 10 years. The average number of antiretrovirals in the optimised background therapy was 4, and about 25% of those patients were put on the injectable entry inhibitor enfuvirtide as a new medication in the optimised background treatment.

The average age was 43 years; about 90% of the participants were men, and their mean viral load at baseline was about 4,700 copies/mL. The mean CD4-positive T-cell count was about 250 copies/mm³.

Five people died during the trial, but no deaths were related to study medication, the researchers noted. The rate of serious adverse events was about 0.7 events per 100 person-years.

Funding for this study was provided by Merck Research Laboratories.

[Presentation title: 144-Week Efficacy and Safety of Raltegravir (RAL) in Treatment-Experienced Patients. Abstract 276]

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