Cardiovascular disease risk factors in HIV-infected women after initiation of lopinavir/ritonavir- and nevirapine-based antiretroviral therapy in Sub-Saharan Africa: A5208 (OCTANE)

Abstract

Background: Limited comparative, prospective data exist regarding cardiovascular risk factors in HIV-infected women starting antiretroviral therapy in Africa.

Methods: In 7 African countries, 741 women with CD4 <200 cells/mm were randomized to tenofovir/emtricitabine (TDF/FTC) plus either nevirapine (NVP, n = 370) or lopinavir/ritonavir (LPV/r, n = 371). Lipids and blood pressure (BP) were evaluated at entry, 48, 96, and 144 weeks. Multivariable linear and logistic regression models were used to evaluate mean risk factor changes and clinically relevant risk factor changes.

Results: At entry, both NVP and LPV/r groups were similar regarding age [mean = 33.5 (SD = 7.1) years], CD4 [129 (67) cells/mm], and HIV-1 RNA [5.1 (0.6) log10 copies/mL]. Nearly, all women had normal lipids and BP except for high-density lipoprotein (HDL)-cholesterol. Over 144 weeks, the LPV/r compared with NVP group had significantly greater mean lipid increases (eg, non-HDL: +29 vs. +13 mg/dL) and smaller HDL increases (+12 vs. +21 mg/dL). In contrast, the NVP compared with LPV/r group had greater mean increases in BP (eg, diastolic BP: +5 vs. -0.5 mm Hg). Significantly, more women assigned LPV/r had week 144 "abnormal" lipid levels (eg, HDL 29.7% vs. 14.8% and triglycerides 28.6% vs. 8.2%), and significantly, more women assigned NVP had "abnormal" BP (eg, diastolic BP 22.7% vs. 6.5%). Most differences remained significant when adjusted for baseline risk factor, age, CD4, and HIV-1 RNA.

Conclusions: In HIV-infected women initiating antiretroviral therapy in Africa, LPV/r + TDF/FTC was associated with less favorable changes in lipids, and use of NVP + TDF/FTC was associated with less favorable changes in BP.

Figure 1

Mean Cardiovascular Risk Factor Levels Over Time Among Women Receiving Nevirapine- and Lopinavir/Ritonavir-Based Antiretroviral Therapy Figures A-H represent changes in lipid (A-E) and non-lipid (F-H) cardiovascular risk factors over time by Nevirapine (NVP)- and Lopinavir/ritonavir (LPV/RTV)-based ART regimens. ¹Bars are 95% confidence intervals for the mean ²P-values are for comparison of treatments adjusted for age, CD4 count, log10 HIV-1 RNA and cardiovascular risk factor level at baseline ³Abbreviations: NVP, Nevirapine; LPV/RTV, Lopinavir/ritonavir; HDL, high-density lipoprotein; LDL, low-density lipoprotein.