Impact of a lopinavir/ritonavir (Kaletra) based second-line antiretroviral therapy regimen on lipid and lipoprotein profiles in an African setting.
Background: Most resource-constrained countries reserve boosted proteinase inhibitors (PIs) for second-line treatment following WHO recommendations. Lipid profiles at first-line clinical/immunological failure and following PI-based second-line treatment have not been studied in Africa. Methods: DART is a randomized trial comparing HIV/AIDS management strategies in Uganda/Zimbabwe in adults initiating first-line ART and switching to LPV/r-containing second-line treatment at clinical failure (WHO 4) or, in those randomised to laboratory monitoring, at immunological failure. We evaluated fasting lipid profiles at second-line initiation and 48 weeks subsequently in stored samples from patients in Zimbabwe remaining on LPV/r for >48 weeks. Results: 91 patients switched to second-line before 18 September 2006, of whom 66 (73%) had fasting samples at switch and 48 weeks, 14 (15%) died/were lost to follow-up 14 days and 1 (1%) had no samples available. Of the 66 patients included (34 male), 57 (86%) received ZDV/d4T+3TC+TDF first-line, 6 (9%) ZDV/d4T+3TC+NVP, and 3 (5%) ZDV+3TC with TDF and NVP. Initial second-line treatment was NNRTI+LPV/r in 27 (41%), ddI+NNRTI+LPV/r in 33 (50%) and LPV/r+TDF+ddI/3TC/ZDV in the remaining 6 (9%). At second-line initiation median (interquartile range) total cholesterol, LDL, HDL and vLDL cholesterol (in mmol/lire) were 3.3 (2.9-4.2), 1.8 (1.5-2.3), 0.7 (0.6-0.8) and 0.7 (0.6-1.1) respectively, with triglycerides 1.0 (0.7-1.8). Levels were significantly increased after 48 weeks of LPV/r-containing second-line, by mean (standard error) +2.0 (0.1), +1.1 (0.1), +0.5 (0.05) and +0.5( 0.05) respectively (all p7.8 mmol/L) and grade 2 LDL-C (4.1-4.9 mmol/L); no triglycerides were elevated, but 81% had HDL-C
Gomo, Z.; Walker, Z.; Hakim, J.; Reid, A.; Munderi, P.; Kityo, C.; Gibb, D.; Gilks, C.; Musarurwa, C.; DART Trial team. Impact of a lopinavir/ritonavir (Kaletra) based second-line antiretroviral therapy regimen on lipid and lipoprotein profiles in an African setting. Presented at AIDS 2008 – XVII International AIDS Conference, Mexico City, Mexico, 3-8 August 2008. (2008)