Virologic and immunologic impact and durability of enfuvirtide-based antiretroviral therapy in HIV-infected treatment-experienced patients in a clinical setting.
OBJECTIVE
To evaluate the effectiveness and safety of enfuvirtide-based therapy in treatment-experienced patients in a clinical setting.


METHODS
Retrospective study of treatment-experienced patients receiving enfuvirtide-based therapy for a minimum of 2 months. Endpoints included virologic suppression, virologic rebound, immunologic response, and adverse events.


RESULTS
Sixty-four patients were eligible for inclusion in the analysis. Median baseline viral load and CD4+ count were 4.7 log10 copies/mL (interquartile range [IQR], 4.0-5.2) and 150 cells/mm3 (IQR, 60-250), respectively. At month 12, viral load declined by a median of 2.53 log10 copies/mL (IQR, 0.97-3.12). The unadjusted median time to virologic suppression was 7.7 months (95% CI 4.1-10.4 months). Baseline viral load and number of protease inhibitors in the current regimen were significantly associated with virologic suppression following multivariate analysis (hazard ratio [HR] 0.45, 95% CI 0.31-0.63, p < .0001, and HR 0.51, 95% CI 0.27-0.94, p = .03, respectively). Among the 42 patients who attained sustained virologic suppression, 10 experienced virologic rebound during a median follow-up of 13.3 months (IQR, 7.0-19.1). Injection site reactions were reported in 33 (52%) patients, resulting in treatment discontinuation in nine patients.


CONCLUSIONS
Enfuvirtide-based therapy provides durable antiretroviral activity for treatment-experienced patients in a clinical setting.
Loutfy
M R
MR
Department of Medicine, University of Toronto, Toronto, Ontario Maple Leaf Medical Clinical, Toronto, Ontario, Canada. mona.loutfy@wchospital.ca
Antoniou
T
T
Shen
S
S
Diong
C
C
Vlaicu
M
M
Halpenny
R
R
Kovacs
C
C
Fletcher
D
D
Raboud
J M
JM
D000328:Adult; D044966:Anti-Retroviral Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D002170:Canada; D015331:Cohort Studies; D004359:Drug Therapy, Combination; D023381:Endpoint Determination; D000077560:Enfuvirtide; D005260:Female; D006678:HIV / Q000302:isolation & purification*; D015700:HIV Envelope Protein gp41 / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D023581:HIV Fusion Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D006801:Humans; D007267:Injections / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D010446:Peptide Fragments / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012189:Retrospective Studies; D013997:Time Factors; D016896:Treatment Outcome; D019562:Viral Load
D044966:Anti-Retroviral Agents; D015700:HIV Envelope Protein gp41; D023581:HIV Fusion Inhibitors; D010446:Peptide Fragments; D000077560:Enfuvirtide