Combination of 3 New HIV Drugs Drives Virus to Undetectable Levels in Treatment-Experienced Patients: Presented at AIDS 2008

By Ed Susman

MEXICO CITY -- August 8, 2008 -- Doctors were able to drive human immunodeficiency virus (HIV) infection to undetectable levels in patients who had developed therapy-limiting resistant mutations to 3 classes of drugs by treating the patients with a cocktail of the newest and most potent HIV medicines -- raltegravir, etravirine, and darunavir/ritonavir -- researchers reported at the 17th International AIDS Conference (AIDS 2008).

Out of 103 patients -- some of whom had been taking highly active antiretroviral therapy (HAART) for more than 13 years -- 93 (approximately 90%) subjects were able to achieve an undetectable viral load, using the stringent 50 copies/mL benchmark, said Yazdan Yazdanpanah, MD, MSc, Service Universitaire des Maladies Infectieuses et du Voyageur, Centre Hospitalier de Tourcoing, Tourcoing, France.

The patients were treated with the integrase inhibitor raltegravir, the protease inhibitor darunavir, and the non-nucleoside reverse transcriptase inhibitor etravirine, spanning 3 classes of drugs that are aimed at the main enzymes of the virus.

Although this trial did not have a control group, Dr. Yazdanpanah suggested the outcomes were similar or better than those of earlier randomised, controlled clinical trials.

"In patients with resistant viruses and historically few remaining treatment options, raltegravir plus darunavir plus etravirine resulted in a high rate of virologic suppression and was generally well tolerated," Dr. Yazdanpanah stated in an oral late-breaker presentation here on August 7.

The trial, dubbed "TRIO" for the 3-drug combination, was sponsored by the French AIDS research agency and is a phase 2 noncomparative study of the 3 drugs in highly treatment-experienced patients. All 3 of the drugs used in the TRIO study have been previously tested against other drugs, but this is the first major trial to combine them, Dr. Yazdanpanah noted.

The researchers enrolled 103 patients between April and August 2007, with a median of 13 years of HAART; 101 subjects completed the first 24 weeks of the study.

Resistance mutations were common, with a median of 4 mutations against protease inhibitors, 5 against nucleoside reverse transcriptase inhibitors, and 1 against non-nucleoside reverse transcriptase inhibitors. At baseline, the median viral load was more than 40,000 copies/mL, and the average reduction in viral load among the 90% of patients who reached the level of undetectability was 2.4 log10 copies.

This study also marked an average 94-cell increase in CD4-positive T cells from a median of 255 at baseline.

Funding for this study was provided by the French National Agency for AIDS Research (Agence Nationale de Recherche sur le Sida).

[Presentation title: High Rate of Virologic Success With Raltegravir Plus Etravirine and Darunavir/Ritonavir in Treatment-Experienced Patients With Multidrug-Resistant Virus: Results of the ANRS 139 TRIO Trial.]

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