title: Raltegravir versus Efavirenz regimens in treatment-naive HIV-1-infected patients: 96-week efficacy, durability, subgroup, safety, and metabolic analyses.
abstract: BACKGROUND
  We analyzed the 96-week results in the overall population and in prespecified subgroups from the ongoing STARTMRK study of treatment-naive HIV-infected patients.
  
  
  METHODS
  Eligible patients with HIV-1 RNA (vRNA) levels >5000 copies per milliliter and without baseline resistance to efavirenz, tenofovir, or emtricitabine were randomized in a double-blind noninferiority study to receive raltegravir or efavirenz, each combined with tenofovir/emtricitabine.
  
  
  RESULTS
  At week 96 counting noncompleters as failures, 81% versus 79% achieved vRNA levels <50 copies per milliliter in the raltegravir and efavirenz groups, respectively [Delta (95% confidence interval) = 2% (-4 to 9), noninferiority P < 0.001]. Mean change in baseline CD4 count was 240 and 225 cells per cubic millimeter in the raltegravir and efavirenz groups, respectively [Delta (95% confidence interval) = 15 (-13 to 42)]. Treatment effects were consistent across prespecified baseline demographic and prognostic subgroups. Fewer drug-related clinical adverse events (47% versus 78%; P < 0.001) occurred in raltegravir than efavirenz recipients. Both regimens had modest effects on serum lipids and glucose levels and on body fat composition.
  
  
  CONCLUSIONS
  When combined with tenofovir/emtricitabine in treatment-naive patients, raltegravir exhibited durable antiretroviral activity that was noninferior to the efficacy of efavirenz through 96 weeks of therapy. Subgroup analyses were generally consistent with the overall findings. Both regimens were well tolerated.
authors.affiliation: Emory University School of Medicine, Atlanta, GA, USA.
authors.forename: Jeffrey L
authors.initials: JL
authors.lastname: Lennox
authors.forename: Edwin
authors.initials: E
authors.lastname: Dejesus
authors.forename: Daniel S
authors.initials: DS
authors.lastname: Berger
authors.forename: Adriano
authors.initials: A
authors.lastname: Lazzarin
authors.forename: Richard B
authors.initials: RB
authors.lastname: Pollard
authors.forename: Jose Valdez
authors.initials: JV
authors.lastname: Ramalho Madruga
authors.forename: Jing
authors.initials: J
authors.lastname: Zhao
authors.forename: Hong
authors.initials: H
authors.lastname: Wan
authors.forename: Christopher L
authors.initials: CL
authors.lastname: Gilbert
authors.forename: Hedy
authors.initials: H
authors.lastname: Teppler
authors.forename: Anthony J
authors.initials: AJ
authors.lastname: Rodgers
authors.forename: Richard J O
authors.initials: RJ
authors.lastname: Barnard
authors.forename: Michael D
authors.initials: MD
authors.lastname: Miller
authors.forename: Mark J
authors.initials: MJ
authors.lastname: Dinubile
authors.forename: Bach-Yen
authors.initials: BY
authors.lastname: Nguyen
authors.forename: Randi
authors.initials: R
authors.lastname: Leavitt
authors.forename: Peter
authors.initials: P
authors.lastname: Sklar
mesh_terms: D000328:Adult; D000368:Aged; D000480:Alkynes; D019380:Anti-HIV Agents / Q000009:adverse effects / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active / Q000009:adverse effects / Q000379:methods*; D048588:Benzoxazines / Q000009:adverse effects / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D003521:Cyclopropanes; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D015497:HIV-1 / Q000302:isolation & purification; D006801:Humans; D008297:Male; D008875:Middle Aged; D011760:Pyrrolidinones / Q000009:adverse effects / Q000627:therapeutic use*; D012367:RNA, Viral / Q000097:blood; D000068898:Raltegravir Potassium; D016896:Treatment Outcome; D019562:Viral Load; D055815:Young Adult
chemical_list: D000480:Alkynes; D019380:Anti-HIV Agents; D048588:Benzoxazines; D003521:Cyclopropanes; D011760:Pyrrolidinones; D012367:RNA, Viral; D000068898:Raltegravir Potassium; C098320:efavirenz
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