title: Safety of fosamprenavir in a cohort of HIV-1-infected patients with co-morbidities.
abstract: BACKGROUND
  The hypothesis that fosamprenavir-including highly active antiretroviral therapy (HAART) regimens would be associated with few metabolic and hepatic side-effects was investigated.
  
  
  METHODS
  An observational single-arm retrospective study was set up on a cohort of 139 human immunodeficiency virus (HIV)-infected patients, followed up at A.O.R.N. Cotugno Hospital, Naples, Italy, treated with antiretroviral regimens including fosamprenavir, in order to evaluate the safety of these regimens in relationship to hepatic and metabolic side-effects, also considering co-morbidities and other risk factors.
  
  
  RESULTS
  Only seven patients met the criteria to reach the primary end-point (grade ≥ 3 adverse event) and none of them discontinued HAART therapy during the follow-up period. Eighty percent of the patients reached viral load <50 cp/μl at 48 weeks of observation. At the end of follow-up, no patient with fasting serum total cholesterol and/or fasting serum triglycerides above grade 3 was found, while 1 out of 114 (0.88%) cases presented aspartate transaminase and alanine transaminase ≥ grade 3 and 1 out of 114 (0.88%) cases had fasting serum glucose ≥ grade 3. One out of 137 patients developed a malignant neoplasm (0.73%) and 4 (2.92%) displayed newly diagnosed hypertension.
  
  
  CONCLUSIONS
  Fosamprenavir-based regimens caused a low number of serious metabolic adverse events during a 48 week follow-up period, with a low incidence of co-morbidities and satisfying results in terms of viro-immunological response including for patients with already existing co-morbidities requiring other therapies.
authors.affiliation: III Division of Infectious Diseases A.O.R.N. Cotugno, Via G. Quagliariello 54, 80131 Naples, Italy. esposvin@libero.it
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Esposito
authors.forename: Paolo
authors.initials: P
authors.lastname: Chiodini
authors.forename: Rosaria
authors.initials: R
authors.lastname: Viglietti
authors.forename: Roberto
authors.initials: R
authors.lastname: Parrella
authors.forename: Giovanni
authors.initials: G
authors.lastname: Parrella
authors.forename: Adelaide
authors.initials: A
authors.lastname: Maddaloni
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Sangiovanni
authors.forename: Miriam
authors.initials: M
authors.lastname: Gargiulo
authors.forename: Nicola
authors.initials: N
authors.lastname: Abrescia
authors.forename: Antonio
authors.initials: A
authors.lastname: Chirianni
mesh_terms: D000410:Alanine Transaminase / Q000097:blood; D001219:Aspartate Aminotransferases / Q000097:blood; D001786:Blood Glucose; D002219:Carbamates / Q000009:adverse effects* / Q000627:therapeutic use; D002784:Cholesterol / Q000097:blood; D015331:Cohort Studies; D015897:Comorbidity; D005260:Female; D005663:Furans; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy* / Q000453:epidemiology; D015497:HIV-1; D019698:Hepatitis C, Chronic / Q000150:complications; D006801:Humans; D006973:Hypertension / Q000453:epidemiology*; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000453:epidemiology*; D010755:Organophosphates / Q000009:adverse effects* / Q000627:therapeutic use; D012189:Retrospective Studies; D013449:Sulfonamides / Q000009:adverse effects* / Q000627:therapeutic use; D014280:Triglycerides / Q000097:blood
chemical_list: D001786:Blood Glucose; D002219:Carbamates; D005663:Furans; D010755:Organophosphates; D013449:Sulfonamides; D014280:Triglycerides; D002784:Cholesterol; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase; C426859:fosamprenavir