title: 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.
authors.affiliation: *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).
authors.forename: Douglas
authors.initials: D
authors.lastname: Shaffer
authors.forename: Michael D
authors.initials: MD
authors.lastname: Hughes
authors.forename: Fredrick
authors.initials: F
authors.lastname: Sawe
authors.forename: Yajing
authors.initials: Y
authors.lastname: Bao
authors.forename: Agnes
authors.initials: A
authors.lastname: Moses
authors.forename: Evelyn
authors.initials: E
authors.lastname: Hogg
authors.forename: Shahin
authors.initials: S
authors.lastname: Lockman
authors.forename: Judith
authors.initials: J
authors.lastname: Currier
mesh_terms: D000225:Adenine / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D000328:Adult; D017954:Africa South of the Sahara; D019380:Anti-HIV Agents / Q000009:adverse effects / Q000627:therapeutic use; D023241:Antiretroviral Therapy, Highly Active / Q000009:adverse effects; D001794:Blood Pressure / Q000187:drug effects; D015992:Body Mass Index; D015496:CD4-Positive T-Lymphocytes; D002318:Cardiovascular Diseases / Q000453:epidemiology*; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D003841:Deoxycytidine / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D000068679:Emtricitabine; D023381:Endpoint Determination; D005260:Female; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy*; D015497:HIV-1 / Q000254:growth & development / Q000302:isolation & purification; D006801:Humans; D016014:Linear Models; D016015:Logistic Models; D061466:Lopinavir / Q000009:adverse effects* / Q000627:therapeutic use; D015999:Multivariate Analysis; D019829:Nevirapine / Q000009:adverse effects* / Q000627:therapeutic use; D063065:Organophosphonates / Q000009:adverse effects / Q000627:therapeutic use; D011446:Prospective Studies; D012367:RNA, Viral / Q000302:isolation & purification; D012307:Risk Factors; D019438:Ritonavir / Q000009:adverse effects* / Q000627:therapeutic use; D000068698:Tenofovir; D014280:Triglycerides / Q000097:blood
chemical_list: D019380:Anti-HIV Agents; D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D063065:Organophosphonates; D012367:RNA, Viral; D014280:Triglycerides; D003841:Deoxycytidine; D061466:Lopinavir; D019829:Nevirapine; D000068698:Tenofovir; D000068679:Emtricitabine; D000225:Adenine; D019438:Ritonavir