Standard ART plus maraviroc does not improve outcomes in treatment-naïve HIV patients

Adding maraviroc to standard combined antiretroviral therapy (c-ART), which consists of three or more ART drugs, does not result in better clinical outcomes among patients initiating treatment for advanced HIV infection, reveals a study.

A total of 409 HIV-positive, antiretroviral-naïve adults with CD4 counts <0.200 × 10⁹ cells/L and/or a previous AIDS-defining event (ADE) were enrolled in this randomized controlled trial to assess the benefit of adding maraviroc to standard c-ART.

Of the participants, 202 were assigned to maraviroc and 207 to placebo. Participants received c-ART plus placebo or maraviroc (300 mg twice daily with dose modification) for 72 weeks.

During follow-up, the primary endpoint of first occurrence of severe morbidity (ie, new ADE, selected serious infections, serious non-ADE, immune reconstitution inflammatory syndrome or death) was comparable between the two treatment groups (11.1 vs 11.2 person-years in the maraviroc and placebo groups, respectively; hazard ratio, 0.97, 95 percent confidence interval [CI], 0.57–1.67).

In addition, the incidence of adverse events grade ≥2 was 36.1 vs 41.5 per 100 person-years (incidence rate ratio, 0.87, 95 percent CI, 0.65–1.15), respectively.

Certain limitations have to considered. First, 64 patients discontinued treatment during follow-up. Second, the study was not powered to assess time-dependent outcomes or effect modification.

“Patients diagnosed with advanced HIV infection have a poor prognosis despite initiation of c-ART,” the investigators said.

Maraviroc is an ART with immunologic effects, they noted.