Reasons for Discontinuation of Nevirapine-based HAART Regimens
The
objective of the current study, conducted by Italian researchers at Riuniti Hospital
in Bergamo, Italy, was to evaluate the frequency of and predictive factors for
discontinuation of HAART regimens containing nevirapine
(Viramune).
All
patients receiving nevirapine as a component of HAART at the hospital between
January 1999 and June 2006 were retrospectively evaluated to assess the drug's
efficacy and tolerability.
A
total of 582 patients (72% men) received 744 nevirapine-based HAART regimens;
136 patients used nevirapine once daily as opposed to the usual twice-daily dosing.
Treatment-naive patients accounted for 83 of these regimens. Of the remaining
661 regimens administered to treatment-experienced patients, 306 were experiencing
virological failure and 355 were undergoing treatment simplification.
The
researchers conducted logistic regression analyses to evaluate the influence of
baseline characteristics on outcomes, and Kaplan-Meier estimates to evaluate time-dependent
variables.
Results
•
The likelihood
of staying on a nevirapine-based regimen was significantly associated with:
-
patient's treatment status (mean Kaplan-Meier estimate of 812 days for those with
virological failure, 1294 for treatment-naive patients, and 1657 for treatment
simplifications) (P < 0.0001);
- dosing schedule (mean 1315 days for
once-daily use and 1198 days for twice-daily use) (P < 0.0001).
•
The most frequent reasons
for treatment discontinuation were:
•
A Grade 3 or greater increase
in aminotransferase levels was observed during 10.2% of the treatments, reflecting
an overall incidence rate of 5.3 cases per 100 person-years.
•
Treatment discontinuation occurred in 3.9% of cases.
Conclusion
Based
on these findings, the authors concluded, "Nevirapine, especially when used
in simplification strategies, enables doctors to extend the use of HAART over
a long period of time."
"The
risk of drug-induced hepatotoxicity is low, but nevirapine should be used with
caution in patients co-infected with hepatitis C virus
or with elevated liver function tests."
"As
with any decision to prescribe a drug, a careful evaluation of the potential risks
and benefits of using nevirapine must be made for each individual."
Divisione
di Malattie Infettive, Ospedali Riuniti, Bergamo, Italy.
02/16/07
References
F
Maggiolo F, C Arici C, M Airoldi, and others. Reasons for discontinuation of nevirapine-containing
HAART: results from an unselected population of a large clinical cohort. Journal
of Antimicrobial Chemotherapy. Jan 25, 2007. [Epub ahead of print].
F
Maggiolo and others. Clinical experience with nevirapine: a cohort analysis. 8th
International Congress on Drug Therapy in HIV Infection. November 12-16, 2007.
Glasgow, UK. Abstract P36.
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