Switching the nucleoside reverse transcriptase inhibitor backbone to tenofovir disoproxil fumarate + emtricitabine promptly improves triglycerides and low-density lipoprotein cholesterol in dyslipidaemic patients.
ABSTRACT To assess the impact of switching to tenofovir disoproxil fumarate + emtricitabine on lipid parameters.
HIV-infected patients with plasma viral load <400 copies/mL, fasted triglycerides from 2.3 to 11.4 mmol/L and/or fasted low-density lipoprotein (LDL)-cholesterol >4.1 mmol/L were randomized to switch the nucleoside reverse transcriptase inhibitor (NRTI) backbone to fixed-dose combination tenofovir disoproxil fumarate + emtricitabine or to maintain the baseline antiretroviral regimen (the control group). The study has been registered with ClinicalTrials.gov under the identifier NCT00323492.
Ninety-one patients were included in the intent-to-treat (ITT) analysis with triglycerides 2.4 mmol/L and LDL-cholesterol 4.0 mmol/L (median values). At week 12, the median changes from baseline of triglycerides were -0.5 mmol/L (-25%; n = 46) and -0.1 mmol/L (-6%; n = 45) in the tenofovir disoproxil fumarate + emtricitabine and control groups, respectively, indicating a difference of -0.4 mmol/L (P = 0.034) [95% confidence interval (CI): -0.9 to -0.0]. Similarly for LDL-cholesterol, changes of -0.4 mmol/L (-9%) and -0.1 mmol/L (-1%) were observed in the tenofovir disoproxil fumarate + emtricitabine and control groups, respectively, indicating a difference of -0.4 mmol/L (P = 0.031) [95% CI: -0.7 to -0.0]. The proportion of patients with LDL-cholesterol >4.1 mmol/L decreased from 48% at baseline to 26% at week 12 in the tenofovir disoproxil fumarate + emtricitabine group versus no change in the control group. No virological failure was observed during the study.
Switching to tenofovir disoproxil fumarate + emtricitabine in dyslipidaemic HIV-infected patients improves triglycerides and LDL-cholesterol.
SourceAvailable from: Jean-Pierre Van Geertruyden[Show abstract] [Hide abstract]
ABSTRACT: Studies on dyslipidaemia in human immunodeficiency virus (HIV) infected people have reported on lipoproteins and lipoprotein subclass profiles. Lipoprotein subclasses are regarded as more accurate measures of cardiovascular disease (CVD) risk than levels of lipoproteins. In this review, the primary objective was to compare and contrast the distribution patterns of lipoprotein and lipoprotein subclasses in highly active antiretroviral therapy (HAART) naïve people and those on HAART based on available literature. PubMed, Science Direct and Google were searched using a combination of various keywords, and relevant English language articles were selected. HIV infection is associated with a decrease of high density lipoprotein-cholesterol (HDL-C), low density lipoprotein-cholesterol (LDL-C), total cholesterol (TC), with increased triglycerides (TG) accompanied by noticeable decreases in total HDL-particles (HDL-p), small dense HDL-p, total LDL-particles (LDL-p) and small dense LDL-p. Acquired immunodeficiency syndrome (AIDS) is associated with increase in small dense LDL-p and decreased HDL-p. HAART, especially protease inhibitor (PI)-based, is associated with increase in lipoprotein levels and levels of total LDL-p and small dense LDL-p, while the non-nucleoside reverse transcriptase inhibitors (NNRTI)-based HAART is associated with smaller increase in lipoprotein levels and significant increase in HDL-p. In addition to a predominance of small dense LDL-p, patients on HAART, especially PI-based have low HDL-p levels. This subclass pattern increases the risk of CVD in HIV-infected people. The use of NNRTI-based HAART or newer PI drugs such as atazanavir, associated with a less atherogenic subclass profile could defer premature CVD in HIV-infected people. As most studies were conducted in Western countries and in people whose ethnicity is different from the ethnicity of people from sub-Saharan Africa, there is a need to analyse lipoprotein subclasses in HIV- infected people, especially in sub-Saharan Africa where HIV infection is most prevalent
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ABSTRACT: In the PROMOTE-pediatrics trial, HIV-infected Ugandan children randomized to receive lopinavir-ritonavir (LPV/r)-based antiretroviral therapy (ART) experienced a lower incidence of malaria compared to children receiving non-nucleoside-reverse-transcriptase-inhibitor (NNRTI)-based-ART. Here we present the results of the non-inferiority (NI) analysis of virologic efficacy and comparison of immunologic outcomes. ART-naïve or -experienced (HIV RNA < 400 copies/ml) children ages 2 months to 6 years received either LPV/r or NNRTI-based-ART. The proportion of children with virologic suppression (HIV RNA <400copies/ml) at 48 weeks was compared using a pre-specified NI margin of -11% in per-protocol analysis. Time to virologic failure by 96 weeks, change in CD4 counts and percentages, and incidence of adverse event rates were also compared. Of 185 children enrolled, 91 initiated LPV/r and 92 initiated NNRTI-based ART. At baseline, the median age was 3.1 years (range: 0.4 to 5.9) and 131 (71%) were ART-naïve. The proportion of children with virologic suppression at 48 weeks was 80% (67/84) in the LPV/r-arm vs. 76% (59/78) in the NNRTI-arm, a difference of 4% (95%CI: -9% to +17%). Time to virologic failure, CD4 changes, and the incidence of DAIDS grade III/IV adverse events were similar between arms. LPV/r-based ART was not associated with worse virologic efficacy, immunologic efficacy, or adverse event rates compared to NNRTI-based ART. Considering these results and the reduction in malaria incidence associated with LPV/r previously reported for this trial, wider use of LPV/r to treat HIV-infected African children in similar malaria endemic settings could be considered.JAIDS Journal of Acquired Immune Deficiency Syndromes 12/2013; DOI:10.1097/QAI.0000000000000071 · 4.39 Impact Factor
Value in Health 11/2006; 9(6). DOI:10.1016/S1098-3015(10)63251-2 · 2.89 Impact Factor