Abstract
BackgroundHIV infection and antiretroviral treatment are associated with changes in lipid levels, insulin resistance and risk of cardiovascular disease (CVD). We investigated these changes in the first 96 weeks of treatment with low-dose stavudine or tenofovir regimens.MethodsThis is a secondary analysis of a double blind, randomised controlled trial performed in South-Africa, Uganda and India comparing low-dose stavudine (20 mg twice daily) with tenofovir in combination with efavirenz and lamivudine in antiretroviral-naïve adults (n = 1067) (Clinicaltrials.gov, NCT02670772). Over 96 weeks, data were collected on fasting lipids, glucose and insulin. Insulin resistance was assessed with the HOMA-IR index and 10-year CVD risk with the Framingham risk score (FRS). A generalized linear mixed model was used to estimate trends over time.ResultsParticipants were on average 35.3 years old, 57.6% female and 91.8% Black African. All lipid levels increased following treatment initiation, with the sharpest increase in the first 24 weeks of treatment. The increase in all lipid subcomponents over 96 weeks was higher among those in the stavudine than the tenofovir group. Insulin resistance increased steadily with no difference detected between study groups. FRS rose from 1.90% (1.84–1.98%) at baseline to 2.06 (1.98–2.15%) at week 96 for the total group, with no difference between treatment arms (p = 0.144). Lipid changes were more marked in Indian than African participants.ConclusionLipid levels increased in both groups, with low-dose stavudine resulting in a worse lipid profile compared to tenofovir. Insulin resistance increased, with no difference between regimens. CVD risk increased over time and tended to increase more in the group on stavudine. The low CVD risk across both arms argues against routine lipid and glucose monitoring in the absence of other CVD risk factors. In high risk patients, monitoring may only be appropriate at least a year after treatment initiation.
Highlights
Cardiovascular disease (CVD) is the leading cause of mortality [1]
Human immunodeficiency virus (HIV) infection and treatment with antiretroviral therapy (ART) affects risk factors for cardiovascular disease (CVD) [2,3,4,5] and some studies indicate that HIV infection increases the risk of myocardial infarction or stroke by up to 50% [6, 7]
A randomised 1:1 double blind placebo-controlled trial was conducted in Johannesburg, South Africa, Kampala, Uganda and Chennai, India to assess the efficacy and safety of treatment with either low dose stavudine (20 mg twice a day) or tenofovir (300 mg daily) tablets administered in combination with lamivudine (150 mg BD) and efavirenz (600 mg daily) over 96 weeks (Clinicaltrials.gov, NCT02670772)
Summary
Cardiovascular disease (CVD) is the leading cause of mortality [1]. Low- and middle-income countries (LMICs) share this burden: the leading cause of death has changed from infectious diseases to ischaemic heart disease over the last two decades [1]. Extensive metabolic and toxicity monitoring allow us to conduct an in-depth analysis of the effects of ART initiation with low-dose stavudine or tenofovir on lipid levels, insulin resistance and CVD risk, an important analysis as the vast majority of people on ART are taking regimens containing tenofovir. We present these results in this paper. HIV infection and antiretroviral treatment are associated with changes in lipid levels, insulin resistance and risk of cardiovascular disease (CVD) We investigated these changes in the first 96 weeks of treatment with lowdose stavudine or tenofovir regimens
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
