Safety, tolerability, and efficacy of raltegravir in a diverse cohort of HIV-infected patients: 48-week results from the REALMRK study

Kathleen E. Squires, Linda Gail Bekker, Joseph J. Eron, Benjamin Cheng, Juergen K. Rockstroh, Farid Marquez, Princy Kumar, Melanie Thompson, Rafael E. Campo, Karam Mounzer, Kim M. Strohmaier, Chengxing Lu, Anthony Rodgers, Beth E. Jackson, Larissa A. Wenning, Michael Robertson, Bach Yen T. Nguyen, Peter Sklar

Research output: Contribution to journalArticle

16 Scopus citations

Abstract

The racial diversity and gender distribution of HIV-infected patients make it essential to confirm the safety and efficacy of raltegravir in these populations. A multicenter, open-label, single-arm observational study was conducted in a diverse cohort of HIV-infected patients (goals: ≥25% women; ≥50% blacks in the United States), enrolling treatment-experienced patients failing or intolerant to current antiretroviral therapy (ART) and treatment-naive patients (limited to ≤20%). All patients received raltegravir 400 mg b.i.d. in a combination antiretroviral regimen for up to 48 weeks. A total of 206 patients received study treatment at 34 sites in the United States, Brazil, Dominican Republic, Jamaica, and South Africa: 97 (47%) were female and 153 (74%) were black [116 (56%) in the United States]. Of these, 185 patients were treatment experienced: 97 (47%) were failing and 88 (43%) were intolerant to current therapy; 21 patients (10%) were treatment naive. Among treatment-intolerant patients, 55 (63%) had HIV-1 RNA<50 copies/ml at baseline. Overall, 15% of patients discontinued: 13% of men, 18% of women, 14% of blacks, and 17% of nonblacks. At week 48, HIV RNA was <50 copies/ml in 60/94 (64%) patients failing prior therapy, 61/80 (76%) patients intolerant to prior therapy, and 16/21 (76%) treatment-naive patients. Response rates were similar for men vs. women and black vs. nonblack patients. Drug-related clinical adverse events were reported by 8% of men, 18% of women, 14% of blacks, and 9% of nonblacks. After 48 weeks of treatment in a diverse cohort of HIV-infected patients, raltegravir was generally safe and well tolerated with potent efficacy regardless of gender or race.

Original languageEnglish (US)
Pages (from-to)859-870
Number of pages12
JournalAIDS research and human retroviruses
Volume29
Issue number6
DOIs
StatePublished - Jun 1 2013

ASJC Scopus subject areas

  • Immunology
  • Virology
  • Infectious Diseases

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    Squires, K. E., Bekker, L. G., Eron, J. J., Cheng, B., Rockstroh, J. K., Marquez, F., Kumar, P., Thompson, M., Campo, R. E., Mounzer, K., Strohmaier, K. M., Lu, C., Rodgers, A., Jackson, B. E., Wenning, L. A., Robertson, M., Nguyen, B. Y. T., & Sklar, P. (2013). Safety, tolerability, and efficacy of raltegravir in a diverse cohort of HIV-infected patients: 48-week results from the REALMRK study. AIDS research and human retroviruses, 29(6), 859-870. https://doi.org/10.1089/aid.2012.0292