Once-Daily Darunavir/Ritonavir Monotherapy as Effective as Standard HAART: Presented at IAS
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Once-Daily Darunavir/Ritonavir Monotherapy as Effective as Standard HAART: Presented at IAS

By Charlene Laino

CAPE TOWN, South Africa -- July 23, 2009 -- For the treatment of HIV patients with undetectable viral loads, once-daily darunavir/ritonavir monotherapy is as effective as darunavir/ritonavir in combination with 2 nucleoside reverse-transcriptase inhibitors (NRTIs).

Use of the monotherapy could help patients avoid the toxicity associated with NRTIs and reduce the cost of treatment, said Jose Arribas, MD, Internal Medicine, Hospital La Paz, Madrid, Spain.

Dr. Arribas presented the findings on July 21 at the 5th International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention.

The trial enrolled 256 patients who had an undetectable plasma viral load of <50 copies/mL for at least 6 months before the trial. Patients were randomly assigned to darunavir/ritonavir 800/100 mg once a day as monotherapy (n = 127) or triple-combination therapy containing 2 NRTIs and darunavir/ritonavir (n = 129).

The primary endpoint was the proportion of patients whose viral load remained suppressed at the end of the first 48 weeks of the 96-week study, he said. The darunavir-alone regimen was considered noninferior if the difference was <12%.

At week 48, 97.6% of patients in the darunavir/ritonavir monotherapy arm maintained viral loads <50 copies/mL, compared with 97.7% of patients in the triple-combination therapy (P = NS).

Patients in the monotherapy arm experienced more “viral blips” -- single readings in which patients had viral loads >50 copies/mL -- than patients in the triple-therapy arm, Dr. Arribas said.

Nonetheless, darunavir/ritonavir monotherapy showed “consistently noninferior efficacy,” he said.

Funding for this study was provided by Tibotec.

[Presentation title: The MONET trial: Darunavir/Ritonavir Monotherapy Shows Non-Inferior Efficacy to Standard HAART, for Patients With HIV RNA <50 Copies/mL at Baseline. Abstract TUAB106]

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