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Abstract
Safety and gastrointestinal tolerability of 625mg Nelfinavir tablets among HIV-Infected individuals previously receiving 250mg Nelfinavir tablets
K. Abernathy1, H. Hardy2, R. Clincea1, A. Stanic2
Background: The purpose of this study is to compare the safety and gastrointestinal tolerability of nelfinavir 625mg tablet (NFV625)-containing antiretroviral therapy among patients changing from nelfinavir 250mg tablet (NFV250) therapy. Secondary endpoints include virologic and immunologic parameters. The study is a prospective, single arm, open label study.
Methods: Daily diarrhea cards were used to monitor bowel movements, starting at day 0 throughout day 7 while taking NFV250 and for day 7 throughout day 63 while taking NFV625. Results were analyzed by the McNemar’s exact test which compared day 0 to day 56.
Thirty male patients were enrolled with an average age of 48+/-9 years.
Thirty-seven percent were Hispanic, 27% white, and 30% black.
Thirty-three percent of patients were MSM and 37% had Hepatitis C.
The mean time patients had been taking nelfinavir was 1354+/-796 days.
Results: Neither CD4 count (NFV250 509+/-289 vs NFV625 476+/-208 p=0.19) nor CD4% changed significantly (25%+/-9; 25%+/-7 p=0.19). Percentage of patients remaining undetectable did not change significantly (HIV-RNA<75 NFV250 92% vs NFV625 84% P=0.5). Furthermore, ALT values did not change significantly (31.5+/-17.7 vs 37.1+/-22.3 p=0.17).
Both stool consistency and number of stools/day were comparable between patients taking NFV250 and NFV625 tablets. There was a slight trend toward firmer consistency and fewer stools per day in the NFV625 arm. Reports of no nausea (NFV250 82% vs NFV625 89% p=0.69) and reporting no urgency (NFV250 75% vs NFV625 86% p=0.45), and use of anti-diarrheals decreased but non-significantly.
Conclusions: Patients appeared to tolerate both the 250mg and 625mg strengths of nelfinavir well. Diarrhea complaints did not change significantly and there was a trend of improvement with the 625mg nelfinavir formulation. Viral load and CD4 cell counts remained stable. Both formulations were well tolerated and highly efficacious in this population with long-term nelfinavir use and a high hepatitis C rate.
AIDS 2006 - XVI International AIDS Conference
Abstract no.
CDB0704
Suggested Citation
"K.Abernathy, et al.
Safety and gastrointestinal tolerability of 625mg Nelfinavir tablets among HIV-Infected individuals previously receiving 250mg Nelfinavir tablets.
:
AIDS 2006 - XVI International AIDS Conference:
Abstract no.
CDB0704"
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