HIV/AIDS HAART: Simplified maintenance therapy with atazanavir-ritonavir maintains virologic suppression

AIDSWEEKLY Plus; Monday, October 16, 2006
Staff Medical Writers

According to a recent report from the United States, "The long-term adverse effects, expense, and difficulty of adherence to antiretroviral regimens have led to studies of simpler maintenance therapies.

"Maintenance therapy with ritonavir-boosted atazanavir alone is a possible option because of low pill burden, once-daily dosing, safety, and unique resistance profile."

S. Swindells and colleagues at the University of Nebraska Medical Center conducted a study to "assess whether simplified maintenance therapy with atazanavir-ritonavir alone after virologic suppression increases the risk of virologic failure (2 consecutive human immunodeficiency virus type 1 [HIV-1] RNA measurements of greater than or equal to200 copies/mL)."

A single-group, "open-label, multicenter, 24-week pilot study of 36 HIV-infected adults with virologic suppression for 48 weeks or longer receiving their first protease inhibitor (PI)-based regimen" was conducted between "September 1, 2004, and April 18, 2006, at 12 participating AIDS clinical trial units in the United States.

"Participants switched PIs to atazanavir-ritonavir at entry and discontinued nucleoside analog reverse transcriptase inhibitors (NRTIs) after 6 weeks."

The authors continued, Main outcome measures included virologic "failure within 24 weeks of discontinuing NRTIs. Other measures included HIV-1 drug resistance, plasma atazanavir concentrations, adverse events, CD4 cell counts, plasma lipid levels, and HIV-1 RNA levels in seminal plasma.

"Thirty-six participants enrolled and 2 discontinued before simplification to atazanavir-ritonavir alone. Thirty-four patients were included in the analysis of the primary end point after 24 weeks: 1 withdrew voluntarily, and 33 continued the regimen."

"Virologic success (absence of failure) through 24 weeks of simplified therapy occurred in 91% (31 of 34 patients; lower 90% confidence interval limit=85%). Three participants experienced virologic failure 12, 14, and 20 weeks after simplification, with plasma HIV-1 RNA levels of 4730, 1285, and 28397 copies/mL, respectively.

"Resistance testing at failure did not identify PI resistance mutations. Plasma atazanavir concentrations at failure were low or below detection in 2 of 3 participants experiencing failure," reported scientists.

"There were no treatment discontinuations for adverse events after simplification; no significant changes in CD4 cell counts or plasma lipid levels; and no detectable HIV-1 RNA in seminal plasma from all 8 participants tested," Swindells said.

Researchers concluded, "These preliminary data suggest that simplified maintenance therapy with atazanavir-ritonavir alone may be efficacious for maintaining virologic suppression in carefully selected patients with HIV infection. These findings require confirmation in larger, randomized trials of this strategy."

Swindells and colleagues published their study in Journal of the American Medical Association (Regimen simplification to atazanavir-ritonavir alone as maintenance antiretroviral therapy after sustained virologic suppression. JAMA. 2006 Aug 16;296(7):806-14).

For more information, contact S. Swindells, University of Nebraska, Medical Center, Dept. of Internal Medical, 985400 Nebraska Med Center, Omaha, NE 68198, USA.

Publisher contact information for the Journal of the American Medical Association is: American Medical Association, 515 N State St., Chicago, IL 60610-0946, USA.

Keywords: Omaha, Nebraska, United States, HIV/AIDS, Maintenance Therapy, Virologic Suppression, Atazanavir-Ritonavir Therapy, Viral Load.

This article was prepared by AIDS Weekly editors from staff and other reports.

Reference

Swindells S, DiRienzo AG, Wilkin T, et al., “Regimen simplification to atazanavir-ritonavir alone as maintenance antiretroviral therapy after sustained virologic suppression”, JAMA. 2006 Aug 16;296(7):806-14.

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2006-10-16
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