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Sustained Efficacy and Safety of Raltegravir After 5 Years of Combination Antiretroviral Therapy as Initial Treatment of HIV-1 Infection: Final Results of a Randomized, Controlled, Phase II Study (Protocol 004)

Gotuzzo, Eduardo MD*; Markowitz, Martin MD; Ratanasuwan, Winai MD; Smith, Graham MD§; Prada, Guillermo MD; Morales-Ramirez, Javier O. MD; Strohmaier, Kim M. BS#; Lu, Chengxing PhD**; Bhanja, Sanhita MS**; Nguyen, Bach-Yen MD**; Teppler, Hedy MD**for the Protocol 004 Study Team

JAIDS Journal of Acquired Immune Deficiency Syndromes: September 1st, 2012 - Volume 61 - Issue 1 - p 73–77
doi: 10.1097/QAI.0b013e318263277e
Brief Report: Clinical Science

Abstract: Raltegravir as initial HIV therapy was examined in a double-blind study; 160 patients were randomized to raltegravir (400 mg bid after dose-ranging), 38 to efavirenz, both with tenofovir/lamivudine. At week 240, HIV-RNA remained <50 copies per milliliter in 68.8% (raltegravir) versus 63.2% (efavirenz), and CD4 increases were 302 versus 276 cells per microliter, respectively. Early HIV-RNA decline predicted later CD4 increases in both groups. Raltegravir resistance was observed in 3 of 10 raltegravir recipients with virologic failure. Few drug-related adverse events were reported after week 48. Raltegravir had minimal effect on laboratory values, including lipids. Raltegravir with tenofovir/lamivudine showed durable efficacy and good tolerability over 5 years.

*Department to de Enfermedades Infecciosas y Tropicales, Hospital Nacional Cayetano Heredia, Lima, Peru

Aaron Diamond AIDS Research Center, Rockefeller University, New York, NY

Department of Preventive & Social Medicine, Siriraj Hospital, Bangkok, Thailand

§Canadian Immunodeficiency Research Collaborative, Maple Leaf Medical Clinic, Toronto, Canada

Jefe Seccion de Infectologia, Santa Fe de Bogota University Hospital, Bogotá, Colombia

Clinical Research Puerto Rico, Inc, San Juan, PR

#Global Scientific & Medical Publications

**Clinical Research Infectious Diseases, Merck Sharp & Dohme Corp, Whitehouse Station, NJ.

Correspondence to: Hedy Teppler, MD, Merck Research Laboratories, PO Box 1000, North Wales, PA 19454-1099 (e-mail:

Supported by Merck Sharp & Dohme Corp, a subsidiary of Merck & Co, Inc, provided all funding for the conduct of this study.

Portions of the data were presented at the 6th IAS Conference on HIV Pathogenesis, Treatment and Prevention, July 17–20, 2011, Rome, Italy.

K. M. Strohmaier, C. Lu, S. Bhanja, B. -Y. Nguyen, and H. Teppler are employees of Merck Sharp & Dohme Corp, a subsidiary of Merck & Co, Inc, and may own stock and/or stock options in the Company. M. Markowitz has received research support, speaker fees, and/or consulting fees from Merck. G. Smith has served as a paid lecturer for, served as a scientific advisor for and/or consultant to, and has received research support from Merck, Viiv Health Care, Gilead Sciences Inc, Bristol Myers Squibb, and Abbott Laboratories. E. Gotuzzo, G. Prada and J. O. Morales-Ramirez have received research support from Merck.

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Received January 13, 2012

Accepted June 5, 2012

© 2012 Lippincott Williams & Wilkins, Inc.