PMID- 24672118
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20140327
LR  - 20211021
IS  - 0011-393X (Print)
IS  - 0011-393X (Linking)
VI  - 66
IP  - 2
DP  - 2005 Mar
TI  - Treatment-limiting toxicities associated withnucleoside analogue reverse 
      transcriptase inhibitor therapy: A prospective, observational study.
PG  - 117-29
LID - 10.1016/j.curtheres.2005.04.002 [doi]
AB  - BACKGROUND: The Recover Study is an ongoing, prospective study designed 10 to 
      assess toxicity associated with the use of nucleoside analogue reverse 
      transcriptase inhibitors (NRTIs) (stavudine, zidovudine, lamivudine, didanosine, 
      abacavir) in HIV-1-infected patients receiving highly active antiretroviral 
      therapy (HAART) in routine clinical practice. This project is being conducted at 
      120 HIV units at teaching hospitals across Spain. OBJECTIVE: The aim of this 
      study was to identify the most common treatment-limiting 10 moderate to severe 
      clinical and laboratory adverse effects (AEs), and the individual NRTIs involved 
      in the development of these effects, in HIV-1-infected patients receiving HAART 
      who discontinued use of an NRTI in the Recover Study. METHODS: Patients eligible 
      for participation in the Recover Study are aged10 >/=18 years; have virologically 
      documented HIV-1 infection; have sustained viral suppression (viral load <200 
      cells/mL or stable, heavily experienced [ie, have received >/=3 antiretroviral 
      regimens] patients with viral load <5000 cells/mL) for >/=6 months; are receiving 
      HAART; are undergoing active follow-up; and have developed 2:1 NRTI-associated AE 
      that, in the opinion of a study investigator and under the conditions of routine 
      clinical practice, justified discontinuation of treatment with the offending drug 
      (principal AE/offending NRTI). The present study included patients recruited for 
      the Recover Study between September 2002 and May 2003. RESULTS: A total of 1391 
      patients were enrolled (966 men, 425 women; mean 1 age, 42 years [range, 18-67 
      years]). Five hundred six patients (36.4%) had been diagnosed with AIDS. The mean 
      duration of treatment with the offending NRTI was 74 months (range, 6-156 
      months). Seven hundred nine patients (51.0%) were receiving fourth-line (or more) 
      therapy. Eight hundred twenty-one patients (59.0%) were receiving nonnucleoside 
      analogues, and 552 patients (39.7%), protease inhibitors, as components of their 
      HAART regimens. The NRTIs with the highest discontinuation rates were stavudine 
      (914 patients [65.7%]) and zidovudine (177 [12.7%]). The most frequent 
      NRTI-related AEs were lipoatrophy (550 patients [39.5%]) and peripheral 
      neuropathy (170 [12.2%]). Lipoatrophy was most commonly associated with stavudine 
      (480/550 cases [87.3%]); periph eral neuropathy, with stavudine and didanosine 
      (107/170 [62.9%] and 48/170 [28.2%] cases, respectively); and anemia, with 
      zidovudine (70/77 cases [90.9%]). CONCLUSIONS: The results of this study in 
      patients with HIV-1 recruited in the10 Recover Study and undergoing HAART suggest 
      that long-term treatment with NRTIs is associated with AEs (lipoatrophy, 
      peripheral neuropathy, and lipodystrophy), with morphologic disorders 
      (lipoatrophy, lipodystrophy) being the most common AEs leading to 
      discontinuation. Minimizing these AEs by switching to an NRTI not associated with 
      these AEs (eg, tenofovir) would contribute to adherence and hence efficacy of 
      long-term HAART.
FAU - Palacios, Rosario
AU  - Palacios R
AD  - Infectious Diseases Unit, Hospital Virgen de la Victoria, Malago, Spain.
FAU - Santos, Jesus
AU  - Santos J
AD  - Infectious Diseases Unit, Hospital Virgen de la Victoria, Malago, Spain.
FAU - Camino, Xavier
AU  - Camino X
AD  - Deportment of Infectious Diseases, Donosti Hospital, Donosti, Spain.
FAU - Arazo, Piedad
AU  - Arazo P
AD  - Department of Infectious Diseases, Miguel Servet Hospital, Zaragoza, Spain.
FAU - Torres Perea, Rafael
AU  - Torres Perea R
AD  - Department of Infectious Diseases, Severo Ochoa Hospital, Legones, Madrid, Spain.
FAU - Echevarrfa, Santiago
AU  - Echevarrfa S
AD  - Department of Infectious Diseases, Marques de Voldecilla University Hospital, 
      Santander, Spain.
FAU - Ribera, Esteban
AU  - Ribera E
AD  - Department of Infectious Diseases, Vall d'Hebron Hospital, Autonoma University of 
      Barcelona, Barcelona, Spain.
FAU - Sanchez de la Rosa, Rainel
AU  - Sanchez de la Rosa R
AD  - Medical Department, Gilead Sciences, Madrid, Spain.
FAU - Moreno Guillen, Santiago
AU  - Moreno Guillen S
AD  - Department of Infectious Diseases, Hospital Ramon y Cajol, Madrid, Spain.
CN  - Recover Study Group
LA  - eng
PT  - Journal Article
PL  - United States
TA  - Curr Ther Res Clin Exp
JT  - Current therapeutic research, clinical and experimental
JID - 0372621
PMC - PMC3964549
OTO - NOTNLM
OT  - AIDS
OT  - HIV-1 infection
OT  - abacavir
OT  - didanosine
OT  - highly active antiretroviral therapy
OT  - lamivudine
OT  - nucleoside analogue reverse transcriptase inhibitor toxicity
OT  - stavudine
OT  - tenofovir
OT  - zidovudine
EDAT- 2005/03/01 00:00
MHDA- 2005/03/01 00:01
PMCR- 2005/03/01
CRDT- 2014/03/28 06:00
PHST- 2005/02/07 00:00 [accepted]
PHST- 2014/03/28 06:00 [entrez]
PHST- 2005/03/01 00:00 [pubmed]
PHST- 2005/03/01 00:01 [medline]
PHST- 2005/03/01 00:00 [pmc-release]
AID - S0011-393X(05)00040-8 [pii]
AID - 10.1016/j.curtheres.2005.04.002 [doi]
PST - ppublish
SO  - Curr Ther Res Clin Exp. 2005 Mar;66(2):117-29. doi: 
      10.1016/j.curtheres.2005.04.002.