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Three-Year Outcome Data of Second-Line Antiretroviral Therapy in Ugandan Adults: Good Virological Response but High Rate of Toxicity

Infectious Diseases Institute, Kampala, Uganda, bcastelnuovo{at}idi.co.ug

Laurence John, MRCP

Infectious Diseases Institute, Kampala, Uganda

Fred Lutwama, MBChB

Infectious Diseases Institute, Kampala, Uganda

Allan Ronald, MD, FRCPC

University of Manitoba, Manitoba, Canada

Lisa A. Spacek, MD, PhD

Johns Hopkins School of Medicine, Baltimore, Maryland

Michael Bates, MD

Monogram Biosciences, Inc., South San Francisco, California

Moses R. Kamya, MBChB, MMed, MPH

Makerere University, Kampala, Uganda

Robert Colebunders, MD, PhD

Institute of Tropical Medicine and University of Antwerp, Antwerp, Belgium

Objective. To evaluate the safety and virological response to lopinavir/ritonavir containing second-line therapy after failing a first line nonnucleoside reverse transcriptase inhibitor (NNRTI) based regimen. Design. Prospective 36 months cohort study of patients switched to zidovudine/stavudine plus didanosine plus lopinavir/ritonavir capsules as second-line regimen. Methodology. Structured interview, medical examination, and laboratory assessment performed every 6 months. Results. We enrolled 40 patients; 1 died and 3 were lost to follow-up. Median CD4+ count at baseline was 108 cell/µL, median log viral load was 4.8 copies/mL. Sixteen (40%) patients had baseline genotypic resistant test, 14 (87%) had lamivudine resistance mutations, and all had NNRTIs resistance mutations. At month 36, 82% of the patients achieved viral suppression (<400 copies/ mL) and the median increase in CD4+ count was 214 cell/µL, (interquartile range: 128-295). Twenty-five patients (62%) experienced at least one adverse event. Conclusions. Our study confirms lopinavir/ ritonavir-based second-line regimen but with a high rate of toxicities.

Key Words: virological response • second-line antiretroviral therapy • resource-limited settings

This version was published on January 1, 2009

Journal of the International Association of Physicians in AIDS Care (JIAPAC), Vol. 8, No. 1, 52-59 (2009)
DOI: 10.1177/1545109708328538


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