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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Lactic acidosis and symptomatic hyperlactataemia in a randomized trial of first-line therapy in HIV-infected adults in South Africa
Antiviral Therapy, Volume 16, No. 4, Year 2011
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Description
Background: Lactic acidosis (LA) is a potentially life-threatening complication of antiretroviral (ARV) therapy. Few randomized prospective studies have compared LA between different ARV regimens. Methods: Characterization of cases of LA (serum lactate >5 mmol/l and arterial pH<7.35 or bicarbonate <20 mmol/l) and symptomatic hyperlactataemia (SH; serum lactate >2.2 mmol/l and symptoms) was made in a randomized open-label 2x2 factorial study of stavudine/lamivudine (d4T/3TC)-based versus didanosine/zidovudine-based therapy and lopinavir/ritonavir-based versus efavirenz (EFV)-based therapy in 1,771 HIV-infected adults initiating therapy between 2004 and 2008. Results: The LA incident rate was 3.5/1,000 person-years (95% CI 1.8-5.9), and for combined LA/SH was 11.0/1,000 person-years (95% CI 7.9-14.9). There were two deaths (15% mortality) among 13 LA cases; all 11 survivors experienced symptom resolution and started new ARV regimens. LA cases were more likely to be female (OR 7.19, 95% CI 1.84-40.75; P=0.001) and had a higher body mass index (BMI; P<0.0001) compared with non-cases. There was no increase in LA according to ARV regimen, age or CD4+ T-cell count at randomization. When combined, LA/SH cases (n=41) were more often female (OR 4.76, 95% CI 2.36-10.08; P<0.0001), had increased BMI (P<0.0001), were more likely to be assigned d4T/3TC (OR 3.17, 95% CI 1.50-7.28; P=0.001) and were more likely to be assigned EFV (OR 2.18, 95% CI 1.08-4.61; P=0.026). Conclusions: Female sex and increased BMI were associated with severe LA in this large randomized trial of first-line ARV in South Africa. While female sex, increased BMI and d4T are previously described risk factors for the development of clinically significant lactate elevations, the independent risk associated with EFV is a novel observation warranting further investigation. ©2011 International Medical Press.
Authors & Co-Authors
Dlamini, Judith Nomthandazo
South Africa, Pretoria
South African National Defence Force
Ledwaba, Lotty
South Africa, Pretoria
South African National Defence Force
Mokwena, Nthabiseng
South Africa, Pretoria
South African National Defence Force
Mokhathi, Thabo
South Africa, Pretoria
South African National Defence Force
Orsega, Susan M.
United States, Bethesda
National Institute of Allergy and Infectious Diseases Niaid
Tsoku, Mary
South Africa, Pretoria
South African National Defence Force
Kowo, Hedwig
South Africa, Pretoria
South African National Defence Force
Proschan, Michael A.
United States, Bethesda
National Institute of Allergy and Infectious Diseases Niaid
Khabo, Paul
South Africa, Pretoria
South African National Defence Force
Maja, Patrick
South Africa, Pretoria
South African National Defence Force
Hadigan, Colleen M.
United States, Bethesda
National Institute of Allergy and Infectious Diseases Niaid
Statistics
Citations: 11
Authors: 11
Affiliations: 2
Identifiers
Doi:
10.3851/IMP1790
ISSN:
13596535
Research Areas
Infectious Diseases
Study Design
Randomised Control Trial
Cohort Study
Study Locations
South Africa
Participants Gender
Female