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Three NNRTI-sparing regimens equally effective as first-line HIV treatment
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BOSTON — Three regimens that did not contain non-nucleoside reverse transcriptase inhibitors, or NNRTIs, were equivalent and demonstrated high rates of virologic control as a first-line antiretroviral therapy, researchers said here at the 2014 Conference on Retroviruses and Opportunistic Infections.
“The most common first-line treatment for HIV worldwide is efavirenz-based therapy,” Raphael Landovitz, MD, of the Center for Clinical AIDS Research and Education in the David Geffen School of Medicine at UCLA, said during his presentation. “There are many reasons why patients might not be good candidates for an NNRTI-based regimen, and we wanted to provide a comprehensive assessment of these alternatives.”
Raphael Landovitz
Landovitz and colleagues conducted a randomized trial that included 1,809 patients who were ART-naive and had a viral load >1,000 copies/mL. They were randomly assigned 1:1:1 to atazanavir (Reyataz, Bristol-Myers Squibb) with ritonavir (Norvir, AbbVie), raltegravir (Isentress, Merck) or darunavir (Prezista, Janssen) with ritonavir. All patients also received emtricitabine/tenofovir (Truvada, Gilead). The patients were followed until 96 weeks after the final participant enrolled, and the virologic endpoint was time to virologic failure.
The mean viral load at baseline was 4.6 log10 copies/mL, and 69% had viral loads <100,000 copies/mL. The mean baseline CD4 count was 308 cells/mcL, and 30% of the patients had a CD4 count <200 cells/mcL. Ninety-two percent of the patients completed 96 weeks on the study. The three regimens were equivalent in terms of virologic failure. Among patients on the atazanavir regimen, 88% of patients had a viral load ≤50 copies/mL after 96 weeks vs. 94% in the raltegravir arm and 89% in the darunavir arm in the intent-to-treat analysis.
In terms of treatment discontinuation, 14% of patients in the atazanavir arm, 1% of patients in the raltegravir arm and 5% of patients in the darunavir arm discontinued treatment due to toxicity. The main toxicity was hyperbilirubinemia and jaundice in the atazanavir arm.
“The jaundice was clinically insignificant but cosmetically very disturbing for patients,” Landovitz said. “These patients were permitted to change regimens for an intolerable toxicity, and were allowed to remain in the study.”
Landovitz said the jaundice was the main reason for treatment discontinuation in this study. The second driving factor for treatment discontinuation was gastrointestinal intolerability associated with the boosted protease inhibitors.
In addition, he said resistance was rare among people with virologic failure but was more common in the raltegravir arms.
“When we combined the virologic suppression endpoint with the tolerability endpoint, the raltegravir arm was superior to both boosted protease inhibitor arms,” Landovitz said. “The boosted darunavir arm was also superior to the boosted atazanavir arm.”
Landovitz R. Abstract #85. CROI 2014; March 3-6; Boston.
Disclosure: Gilead provided medicine, equipment or administrative services for the study.