OBJECTIVES: 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, M., DI GIAMBENEDETTO, S., Bracciale, L., Fanti, I., Prosperi, M., Cauda, R., et al. (2009). Long term follow-up of Nevirapine-treated patients in a single centre cohort. HIV MEDICINE, 10(8), 461-469.

Long term follow-up of Nevirapine-treated patients in a single centre cohort

DE LUCA, ANDREA
2009-01-01

Abstract

OBJECTIVES: 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.
2009
Colafigli, M., DI GIAMBENEDETTO, S., Bracciale, L., Fanti, I., Prosperi, M., Cauda, R., et al. (2009). Long term follow-up of Nevirapine-treated patients in a single centre cohort. HIV MEDICINE, 10(8), 461-469.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11365/1011647
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