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  • Title: Virologic and immunologic impact and durability of enfuvirtide-based antiretroviral therapy in HIV-infected treatment-experienced patients in a clinical setting.
    Author: Loutfy MR, Antoniou T, Shen S, Diong C, Vlaicu M, Halpenny R, Kovacs C, Fletcher D, Raboud JM.
    Journal: HIV Clin Trials; 2007; 8(1):36-44. PubMed ID: 17434847.
    Abstract:
    OBJECTIVE: To evaluate the effectiveness and safety of enfuvirtide-based therapy in treatment-experienced patients in a clinical setting. METHOD: 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. CONCLUSION: Enfuvirtide-based therapy provides durable antiretroviral activity for treatment-experienced patients in a clinical setting.
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