title: Meta-analysis of the safety, tolerability, and efficacy of lopinavir/ritonavir-containing antiretroviral therapy in HIV-1-infected women.
abstract: OBJECTIVE
  Women comprise ≯50% of HIV-infected patients, yet safety, tolerability, and efficacy data in women taking antiretrovirals (ARVs) are limited. Lopinavir/ ritonavir (LPV/r)-anchored regimens are globally the most widely prescribed HIV-1 protease inhibitor regimens. The objective was to investigate the safety and efficacy of LPV/r-based therapy in women.
  
  
  METHODS
  A database query yielded all available data in HIV-1-infected subjects receiving LPV/r-based triple-ARV regimens from randomized clinical trials lasting ≥48 weeks from Abbott or Abbott-supported AIDS Clinical Trials Group studies. Efficacy (HIV-1 RNA levels, CD4+ T-cell counts) and safety and tolerability (treatment discontinuation, treatment-related adverse events [AE], and clinical laboratory abnormalities) at 48 weeks were assessed for total women, women by age (≥50, <50 years) and body mass index (BMI; <25, ≥25 to <30, ≥30 kg/m2), and sex.
  
  
  RESULTS
  Nine hundred ninety-two women initiated LPV/r-based therapy (of whom 79.2% were ARV-naïve), with 83.6% completing 48 weeks of treatment. There were 75.5% of women who achieved a threshold of HIV RNA <400 copies/mL by intent-to-treat, non-completer equals failure (ITT, NC = F) analysis, with a mean ± SE CD4+ T-cell count increase of 191.6 ± 4.92 cells/mm3 from baseline. Women aged ≥50 versus <50 years had higher incidence of moderate-to-severe treatment-related AEs and certain laboratory abnormalities, better virologic response (HIV RNA <400 copies/mL by ITT, NC = F), similar immunologic responses, and similar overall incidence of treatment discontinuations. Higher incidences of certain moderate-to-severe treatment-related AEs and laboratory abnormalities occurred in women with BMI ≥30 kg/m2; however, no effect of BMI on efficacy or discontinuation was observed.
  
  
  CONCLUSIONS
  LPV/r-based regimens were efficacious and well-tolerated in women without marked differences based on age and BMI categories evaluated.
authors.affiliation: Abbott Laboratories, Abbott Park, IL, USA. ashwaq.hermes@abbott.com
authors.forename: A
authors.initials: A
authors.lastname: Hermes
authors.forename: K
authors.initials: K
authors.lastname: Squires
authors.forename: L
authors.initials: L
authors.lastname: Fredrick
authors.forename: M
authors.initials: M
authors.lastname: Martinez
authors.forename: M
authors.initials: M
authors.lastname: Pasley
authors.forename: R
authors.initials: R
authors.lastname: Trinh
authors.forename: M
authors.initials: M
authors.lastname: Norton
mesh_terms: D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D000367:Age Factors; D015992:Body Mass Index; D018791:CD4 Lymphocyte Count; D004359:Drug Therapy, Combination; D005260:Female; D017320:HIV Protease Inhibitors / Q000008:administration & dosage*; D015497:HIV-1; D006801:Humans; D061466:Lopinavir / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D012367:RNA, Viral / Q000032:analysis; D019438:Ritonavir / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D017320:HIV Protease Inhibitors; D012367:RNA, Viral; D061466:Lopinavir; D019438:Ritonavir