Effect of Enfuvirtide (Fuzeon) on Adherence to and Efficacy of Antiretroviral Therapy

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Enfuvirtide
(Fuzeon, T-20)

High adherence rates among patients on antiretroviral therapy are associated with increased durability of viral suppression and decreased rates of drug resistance. Enfuvirtide (Fuzeon, T-20) has raised concerns about adherence and efficacy due to the need for twice-daily subcutaneous self-injection.

In the present study, German researchers at the University of Bonn assessed adherence to enfuvirtide plus an optimized background therapy (OBT) antiretroviral regimen, and its impact on virological and immunological responses in the TORO trials.

Results

• In the OBT only arm, 88% of patients reported at least 85% adherence, versus 87% of patients in the OBT + enfuvirtide arm.

• Higher overall adherence was associated with improved virological and immunological response in both treatment arms at 48 weeks.

• In patients with at least 85% adherence, 33% in the OBT + enfuvirtide arm achieved HIV RNA < 400 copies/mL, compared with 13% in the OBT only arm (P < 0.0001).

• Similarly, patients with at least 85% adherence in the OBT + enfuvirtide arm achieved a mean CD4 cell count increase of 104 cells/mm3, compared with 58 cells/mm3 for those in the OBT only arm (P < 0.001).

• None of the demographic factors assessed (age, sex, race) or baseline characteristics (CD4 count, viral load, baseline sensitivity score) was significant in predicting adherence to enfuvirtide when analyzed by multiple regression analysis.

• Importantly, a history of injection drug use was not associated with a significant decrease in adherence (mean adherence 96% for both IDUs and non-IDUs; P = 0.825).

Conclusion

"Adherence was high in patients receiving the self-injectible antiretroviral enfuvirtide," according to the study authors. In addition, they wrote, "The inclusion of enfuvirtide did not negatively impact adherence to the antiretroviral regimen as a whole."

Medizinische Klinik, University of Bonn, Bonn, Germany.

2/26/08

Reference
J Rockstroh, E Dejesus, L Donatacci, and others. Adherence to enfuvirtide and its impact on treatment efficacy. AIDS Patient Care & STDs 22(2): 113-121. February 2008.

HIV and Hepatitis.com Articles on Fuzeon

Additional Reading

J Reynes, K Arasten, B Clotet, and others. TORO: ninety-six-week virologic and immunologic response and safety evaluation of enfuvirtide with an optimized background of antiretrovirals. AIDS Patient Care & STDs 21(8): 533-543. August 2007.

J Molto, L Ruiz, M Valle, and others. Increased antiretroviral potency by the addition of enfuvirtide to a four-drug regimen in antiretroviral-naive, HIV-infected patients. Antiviral Therapy 11(1): 47-51. 2006.