Cardiovascular Disease Risk Factors in HIV-Infected Women After Initiation of Lopinavir/Ritonavir- and Nevirapine-Based Antiretroviral Therapy in Sub-Saharan Africa: A5208 (OCTANE)

Shaffer, Douglas MD, MHS*,†; Hughes, Michael D. PhD; Sawe, Fredrick MBChB, MMED*,†,§; Bao, Yajing MS; Moses, Agnes MD; Hogg, Evelyn BS; Lockman, Shahin MD, MSc‡,#,**; Currier, Judith MD, MSc††

JAIDS Journal of Acquired Immune Deficiency Syndromes: 1 June 2014 - Volume 66 - Issue 2 - p 155–163
doi: 10.1097/QAI.0000000000000131
Clinical Science

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/mm3 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/mm3], 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.

*Kenya Medical Research Institute/Walter Reed Project, Kericho, Kenya;

U.S. Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD;

Harvard School of Public Health, Boston, MA;

§Henry M. Jackson Foundation for the Advancement of Military Medicine, Rockville, MD;

University of North Carolina Project, Kamuzu Central Hospital, Lilongwe, Malawi;

Social & Scientific Systems, Inc., Silver Spring, MD;

#Brigham and Women's Hospital, Boston, MA;

**Botswana Harvard School of Public Health AIDS Initiative Partnership, Gaborone, Botswana; and

††University of California Los Angeles, Los Angeles, CA (Dr. Douglas Shaffer is now with the U.S. Centers for Disease Control and Prevention (CDC), Kigali, Rwanda).

Correspondence to: Douglas Shaffer, MD, MHS, Centers for Disease Control and Prevention (CDC), US Embassy, Kigali, 2657 Avenue de la Gendarmerie, P.O. Box 28, Kigali, Rwanda (e-mail: DShaffer@cdc.gov).

Supported in part by grants (U01AI068636, AI38838, and Statistical and Data Management Center AI68634) from the National Institute of Allergy and Infectious Diseases to the AIDS Clinical Trials Group. Supported in part by the General Clinical Research Center Units funded by the National Center for Research. D.S. and F.S. as part of the US Military HIV Research Unit Clinical Trials Unit are supported through the National Institute of Allergy and Infectious Diseases-US Army Medical Research and Material Command IAA (#IAAY1AI8374). A.M. is supported through the UNC Project, Kamuzu Central Hospital; Lilongwe (Site 12001) CTU Grant #5 U01 AI069518. J.C. is supported in part by K24 AI56933.

The authors have no conflicts of interest to disclose.

The views expressed are those of the authors and should not be construed to represent the positions of authors' institutions. These funding bodies played no role in study design, data collection, and analysis, decision to publish, or preparation of the article.

Received October 11, 2013

Accepted January 17, 2014

© 2014 by Lippincott Williams & Wilkins