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Evolution of HIV1 infected patient profile treated by Enfuvirtide (Fuzeon ® )
Drogoul-Vey MP 1 , Frixon-Marin V 1 , Ravaux I 2 , Mars-Kallee ME 3 , Gastaut JA 1 , Gallais H 2 ,
Poizot-Martin I 1
1
CISIH Hôpital Sainte Marguerite; Marseille
2
Service Maladies Infectieuses, La Conception; Marseille
3
Roche Pharma France
Introduction
Fuzeon ® ( enfuvirtide) has proven its efficacy and good tolerability through toro trials. Its
optimal benefit has been demonstrated for patients with at initiation CD4 > 100/mm 3 ,
viraemia (VL) < 5log10, the number of antiretrovirals (ARV) used < 10 and combined with
one or two potentially active other ARV. However its prescription is still restricted probably
due to its galenic form. We conducted a multicentric prospective cohort study to evaluate
the evolution of patient profile treated with Fuzeon ® .
Method
From December 2003 to June 2005, all HIV1-infected patients who have started HAART
including Fuzeon ® in 2 units of CISIH of Marseilles (France) were included in a 6 month
prospective cohort study. At baseline viro-immunological status and clinical and
therapeutic history were recorded. Patients were classified in 2 groups in relation to
Fuzeon ® initiation prior or posterior of Consensus Recommendations publication (CRP) in
may 14 th 2004.
Results
30 patients were included (22 males, median age 42 years, 30% in stage C of CDC
classification). Sixteen of them (53%) were HCV coinfected. All were heavily pretreated
(median of ARV exposure 9 years with a median of 12,5 drugs and 8,5 regimen used).
Twelve patients have started Fuzeon ® before and 19 patients after recommendations.
At baseline the majority of patients (64%) had CD4 > 100/mm 3 , a VL < 5log10 but with
prior utilisation of more than 10 ARV with no difference regardless the period of
prescription. Among patients treated after CRP, we noted at baseline a higher median CD4
count (225/mm3 versus 118/mm 3 ) and a larger use of new drugs (25% versus 78% of
cases; p = 0.01).
At M6, VL was < 50 cp/ml in 32% of patients and median CD4 cells count had increased
from 182 to 273/mm 3 (OT analysis). Regarding the period of prescription no difference was
observed.
POSTERS
Conclusion
In this cohort, Fuzeon ® was initiated in patients with an optimal VL and CD4 count but a
too important past of ARV used. This issue is balanced by a larger use of new drugs in
actual favourable context.
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