title: Quantifying the risks and benefits of efavirenz use in HIV-infected women of childbearing age in the USA.
abstract: OBJECTIVE
  The aim of the study was to quantify the benefits (life expectancy gains) and risks (efavirenz-related teratogenicity) associated with using efavirenz in HIV-infected women of childbearing age in the USA.
  
  
  METHODS
  We used data from the Women's Interagency HIV Study in an HIV disease simulation model to estimate life expectancy in women who receive an efavirenz-based initial antiretroviral regimen compared with those who delay efavirenz use and receive a boosted protease inhibitor-based initial regimen. To estimate excess risk of teratogenic events with and without efavirenz exposure per 100,000 women, we incorporated literature-based rates of pregnancy, live births, and teratogenic events into a decision analytic model. We assumed a teratogenicity risk of 2.90 events/100 live births in women exposed to efavirenz during pregnancy and 2.68/100 live births in unexposed women.
  
  
  RESULTS
  Survival for HIV-infected women who received an efavirenz-based initial antiretroviral therapy (ART) regimen was 0.89 years greater than for women receiving non-efavirenz-based initial therapy (28.91 vs. 28.02 years). The rate of teratogenic events was 77.26/100,000 exposed women, compared with 72.46/100,000 unexposed women. Survival estimates were sensitive to variations in treatment efficacy and AIDS-related mortality. Estimates of excess teratogenic events were most sensitive to pregnancy rates and number of teratogenic events/100 live births in efavirenz-exposed women.
  
  
  CONCLUSIONS
  Use of non-efavirenz-based initial ART in HIV-infected women of childbearing age may reduce life expectancy gains from antiretroviral treatment, but may also prevent teratogenic events. Decision-making regarding efavirenz use presents a trade-off between these two risks; this study can inform discussions between patients and health care providers.
authors.affiliation: Harvard Medical School, Boston, MA, USA.
authors.forename: H E
authors.initials: HE
authors.lastname: Hsu
authors.forename: C E
authors.initials: CE
authors.lastname: Rydzak
authors.forename: K L
authors.initials: KL
authors.lastname: Cotich
authors.forename: B
authors.initials: B
authors.lastname: Wang
authors.forename: P E
authors.initials: PE
authors.lastname: Sax
authors.forename: E
authors.initials: E
authors.lastname: Losina
authors.forename: K A
authors.initials: KA
authors.lastname: Freedberg
authors.forename: S J
authors.initials: SJ
authors.lastname: Goldie
authors.forename: Z
authors.initials: Z
authors.lastname: Lu
authors.forename: R P
authors.initials: RP
authors.lastname: Walensky
mesh_terms: D000014:Abnormalities, Drug-Induced / Q000453:epidemiology*; D000328:Adult; D000480:Alkynes; D019380:Anti-HIV Agents / Q000009:adverse effects*; D048588:Benzoxazines / Q000009:adverse effects*; D003521:Cyclopropanes; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000401:mortality; D006801:Humans; D008017:Life Expectancy; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy; D011256:Pregnancy Outcome; D018570:Risk Assessment; D012307:Risk Factors; D013723:Teratogens / Q000633:toxicity*; D014481:United States / Q000453:epidemiology
chemical_list: D000480:Alkynes; D019380:Anti-HIV Agents; D048588:Benzoxazines; D003521:Cyclopropanes; D013723:Teratogens; C098320:efavirenz