title: Response to raltegravir-based salvage therapy in HIV-infected patients with hepatitis C virus or hepatitis B virus coinfection.
abstract: OBJECTIVE
  To define the impact of coinfection with hepatitis B virus (HBV) or hepatitis C virus (HCV) on viroimmunological response to raltegravir-based salvage regimens that also include new HIV inhibitors such as maraviroc, darunavir and etravirine.
  
  
  METHODS
  We used data from a national observational study of patients starting raltegravir-based regimens to compare virological suppression and CD4 cell change from baseline in patients with and without concomitant HBV or HCV infection.
  
  
  RESULTS
  Overall, 275 patients (107 coinfected and 168 non-coinfected) were evaluated. Coinfected patients were more commonly former intravenous drug users and had a longer history of HIV infection and higher baseline aminotransferase levels. Both HIV-RNA and CD4 response were similar in the two groups. Mean time to first HIV-RNA copy number <50 copies/mL was 4.1 months (95% CI 3.5-4.6) in non-coinfected patients and 3.9 months (95% CI 3.3-4.5) in coinfected patients (hazard ratio 1.039, 95% CI 0.761-1.418, P = 0.766, log-rank test). The risk of developing new grade 3-4 hepatic adverse events was significantly higher in coinfected patients (hazard ratio 1.779, 95% CI 1.123-2.817, P = 0.009). The two groups of coinfected and non-coinfected patients had similar rates of interruption of any baseline drug (hazard ratio 1.075, 95% CI 0.649-1.781, P = 0.776) and of raltegravir (hazard ratio 1.520, 95% CI 0.671-3.447, P = 0.311). Few AIDS-defining events and deaths occurred.
  
  
  CONCLUSIONS
  Viroimmunological response to regimens based on raltegravir and other recent anti-HIV inhibitors is not negatively affected by coinfection with HBV or HCV. Liver toxicity, either pre-existing or new, is more common in coinfected patients, but with no increased risk of treatment interruption.
authors.affiliation: Department of Therapeutic Research and Medicines Evaluation,  Istituto Superiore di Sanità, Rome,  Italy.
authors.forename: Liliana Elena
authors.initials: LE
authors.lastname: Weimer
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Fragola
authors.forename: Marco
authors.initials: M
authors.lastname: Floridia
authors.forename: Giovanni
authors.initials: G
authors.lastname: Guaraldi
authors.forename: Nicoletta
authors.initials: N
authors.lastname: Ladisa
authors.forename: Daniela
authors.initials: D
authors.lastname: Francisci
authors.forename: Rita
authors.initials: R
authors.lastname: Bellagamba
authors.forename: Anna
authors.initials: A
authors.lastname: Degli Antoni
authors.forename: Giustino
authors.initials: G
authors.lastname: Parruti
authors.forename: Andrea
authors.initials: A
authors.lastname: Giacometti
authors.forename: Paolo Emilio
authors.initials: PE
authors.lastname: Manconi
authors.forename: Angela
authors.initials: A
authors.lastname: Vivarelli
authors.forename: Gabriella
authors.initials: G
authors.lastname: D'Ettorre
authors.forename: Maria Stella
authors.initials: MS
authors.lastname: Mura
authors.forename: Stefania
authors.initials: S
authors.lastname: Cicalini
authors.forename: Roberta
authors.initials: R
authors.lastname: Preziosi
authors.forename: Laura
authors.initials: L
authors.lastname: Sighinolfi
authors.forename: Gabriella
authors.initials: G
authors.lastname: Verucchi
authors.forename: Raffaella
authors.initials: R
authors.lastname: Libertone
authors.forename: Marcello
authors.initials: M
authors.lastname: Tavio
authors.forename: Loredana
authors.initials: L
authors.lastname: Sarmati
authors.forename: Raffaella
authors.initials: R
authors.lastname: Bucciardini
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015331:Cohort Studies; D060085:Coinfection / Q000188:drug therapy* / Q000453:epidemiology; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000188:drug therapy* / Q000453:epidemiology; D016174:Hepacivirus / Q000187:drug effects; D006509:Hepatitis B / Q000188:drug therapy* / Q000453:epidemiology; D006515:Hepatitis B virus / Q000187:drug effects; D006526:Hepatitis C / Q000188:drug therapy* / Q000453:epidemiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D016879:Salvage Therapy / Q000379:methods*; D016896:Treatment Outcome; D055815:Young Adult