Long-term follow-up of nevirapine-treated patients in a single-centre cohort.
OBJECTIVE
We reviewed the safety and efficacy of nevirapine (NVP)-based therapy in all patients initiating NVP-containing combined antiretroviral therapy [cART (>or=3 drugs)] in our clinic since 1994.


METHODS
Patient characteristics and laboratory values from the start of the NVP-based cART regimen to the last available follow-up or to NVP discontinuation were retrieved from an observational database.


RESULTS
Five hundred and seventy-three patients were treated with NVP-based cART for a median of 18.4 (range 0.1-128.8) months. The 1-year cumulative estimated probability of discontinuing NVP-containing regimens for toxicity was 0.203. Only 1.9% developed a grade 3 alanine aminotransferase (ALT) elevation. Significant increases in high-density lipoprotein cholesterol were observed up to month 12 except in treatment-naïve patients, where the increase was limited to 3 months. Discontinuation because of cutaneous reaction was predicted independently by female gender [Hazard Ratio (HR) 3.21, P<0.001] and Centers for Disease Control class C (HR 0.50, P=0.012). Discontinuation because of liver toxicity was predicted independently by anti-hepatitis C virus positivity (HR 3.84, P<0.001). In patients starting NVP-containing cART with undetectable viral loads, the 5-year estimated probability of viral load >400 HIV-1 RNA copies/mL was 0.34.


CONCLUSIONS
Long-term follow-up with an NVP-containing cART showed a low rate of discontinuation caused by liver toxicity and the maintenance of virological suppression in patients switched with undetectable viral loads.
Colafigli
Manuela
M
Institute of Clinical Infectious Diseases, Catholic University of the Sacred Heart, Rome, Italy. manuela76@inwind.it
Di Giambenedetto
S
S
Bracciale
L
L
Fanti
I
I
Prosperi
M
M
Cauda
R
R
De Luca
A
A
D000328:Adult; D000410:Alanine Transaminase / Q000378:metabolism; D044966:Anti-Retroviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001219:Aspartate Aminotransferases / Q000378:metabolism; D018791:CD4 Lymphocyte Count; D056486:Chemical and Drug Induced Liver Injury / Q000453:epidemiology; D008076:Cholesterol, HDL / Q000097:blood; D015331:Cohort Studies; D003875:Drug Eruptions / Q000453:epidemiology; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000378:metabolism / Q000821:virology; D006801:Humans; D008099:Liver / Q000187:drug effects / Q000201:enzymology; D008297:Male; D019829:Nevirapine / Q000009:adverse effects / Q000627:therapeutic use*; D018894:Reverse Transcriptase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D013997:Time Factors; D016896:Treatment Outcome; D019562:Viral Load; D016903:Drug Monitoring
D044966:Anti-Retroviral Agents; D008076:Cholesterol, HDL; D018894:Reverse Transcriptase Inhibitors; D019829:Nevirapine; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase