|
|
Abstract
Co-administering tipranavir/r (500/200 mg BID) and enfuvirtide (ENF) in the RESIST studies resulted in superior virological outcomes and a comparable safety profile compared to regimens containing tipranavir/r without enfuvirtide
Raffi F.1, Battegay M.2, Rusconi S.3, Opravil M.4, Kraft M.5, Sabo J.P.5
Objectives: To evaluate efficacy and safety of tipranavir/r (TPV/r) with or without enfuvirtide (ENF) in treatment experienced patients.
Methods: Analysis of Week 48 efficacy and safety data from RESIST TPV/r patients who did (ENF+; n=170) or did not (ENF-; n=576) take ENF.
Results: ENF+ patients had more advanced HIV disease at baseline than ENF- patients (median VL: 5.06 vs. 4.72 log10 copies/mL; median CD4 cell count: 74 vs. 179 cells/mm3; CDC Class C: 65.3% vs. 57.8%); taken more ARVs (median: 13.5 vs. 11); fewer were hepatitis co-infected (5.3% vs. 11.8%). Other baseline characteristics were similar. 16.6% (124/746) initiated ENF (new ENF); 6.2% (46/746) recycled ENF (old ENF). At Week 48, 74/170 (43.5%) of ENF+ patients had VLs <400 copies/mL vs. 150/576 (26.4%) ENF-. Values for <50 copies/mL were 50/170 (29.4%) vs. 119/576 (20.7%); old ENF: 4/46 (8.7%); new ENF: 46/124 (37.1%). Mean CD4 cell counts (cells/mm3) increased by 87 in ENF+ (48 old ENF; 102 new ENF) vs. 32 in ENF- patients. Median TPV trough concentrations (Ctrough) were higher in ENF+ patients (45.2 µM) vs. ENF- (31.0 µM) patients. Grade 3/4 transaminase elevation rates were similar in ENF+ and ENF- patients (ALT: 6.5% vs. 12.9%; AST: 4.1% vs. 8.3%). ENF+ patients had lower rates of hepatic AEs than ENF- patients: 5.9 vs. 9.3 events/100 PEY. Similar rates of hepatitis were observed in co-infected ENF+ (22.2%; 2/9) and ENF- (17.6%; 12/68) patients.
Conclusions: Patients taking TPV/r plus ENF in RESIST had superior Week 48 virological and immunological outcomes compared to those not taking ENF. Despite higher TPV Ctrough values in patients taking TPV/r and ENF, hepatic safety was not compromised in these patients. Co-administering enfuvirtide and tipranavir/r with genotypically active RTIs results in undetectable VLs in a substantial proportion of treatment experienced patients, thus achieving current guidelines’ goals.
4th IAS Conference on HIV Pathogenesis, Treatment and Prevention
Abstract no.
WEPEB045
Suggested Citation
"RaffiF., et al.
Co-administering tipranavir/r (500/200 mg BID) and enfuvirtide (ENF) in the RESIST studies resulted in superior virological outcomes and a comparable safety profile compared to regimens containing tipranavir/r without enfuvirtide.
Poster exhibition:
4th IAS Conference on HIV Pathogenesis, Treatment and Prevention:
Abstract no.
WEPEB045"
|
|
|