Background: This collaboration of seven observational clinical cohorts investigated risk factors for treatment-limiting toxicities in both anti retroviral-naive and experienced patients starting nevirapine-based combination antiretroviral therapy (NVPc). Methods: Patients starting NVPc after 1 January 1998 were included. CD4 cell count at starting NVPc was classified as high (>400/mu l/>250/mu l for men/women, respectively) or low. Cox models were used to investigate risk factors for discontinuations due to hypersensitivity reactions (HSR, n = 6547) and discontinuation of NVPc due to treatment-limiting toxicities and/or patient/physician choice (TOXPC, n = 10 186). Patients were classified according to prior antiretroviral treatment experience and CD4 cell count/viral load at start NVPc. Models were stratified by cohort and adjusted for age, sex, nadir CD4 cell count, calendar year of starting NVPc and mode of transmission. Results: Median time from starting NVPc to TOXPC and HSR were 162 days [interquartile range (IQR) 31 -737] and 30 days (IQR 17-60), respectively. In adjusted Cox analyses, compared to naive patients with a low CD4 cell count, treatment-experienced patients with high CD4 cell count and viral load more than 400 had a significantly increased risk for HSR [hazard ratio 1.45, confidence interval (CI) 1.03-2.03] and TOXPC within 18 weeks (hazard ratio 1.34, Cl 1.08-1.67). In contrast, treatment-experienced patients with high CD4 cell count and viral load less than 400 had no increased risk for HSR 1.10 (0.82-1.46) or TOXPC within 18 weeks(hazard ratio 0.94, Cl 0.78-1.13). Conclusion: Our results suggest it may be relatively well tolerated to initiate NVPc in anti retroviral-experienced patients with high CD4 cell counts provided there is no detectable viremia. (C) 2009 Wolters Kluwer Health | Lippincott Williams & Wilkins
Risk factors for treatment-limiting toxicities in patients starting nevirapine-containing antiretroviral therapy / Anouk M., Kesselring; Ferdinand W., Wit; Caroline A., Sabin; Jens D., Lundgren; M., John Gill; Jose M., Gatell; Andri, Rauch; Julio S., Montaner; F., De Wolf; Peter, Reiss; Amanda, Mocroft; Vullo, Vincenzo; Nevirapine Toxicity Multicohort, Collaboration. - In: AIDS. - ISSN 0269-9370. - 23:13(2009), pp. 1689-1699. [10.1097/qad.0b013e32832d3b54]
Risk factors for treatment-limiting toxicities in patients starting nevirapine-containing antiretroviral therapy
VULLO, Vincenzo;
2009
Abstract
Background: This collaboration of seven observational clinical cohorts investigated risk factors for treatment-limiting toxicities in both anti retroviral-naive and experienced patients starting nevirapine-based combination antiretroviral therapy (NVPc). Methods: Patients starting NVPc after 1 January 1998 were included. CD4 cell count at starting NVPc was classified as high (>400/mu l/>250/mu l for men/women, respectively) or low. Cox models were used to investigate risk factors for discontinuations due to hypersensitivity reactions (HSR, n = 6547) and discontinuation of NVPc due to treatment-limiting toxicities and/or patient/physician choice (TOXPC, n = 10 186). Patients were classified according to prior antiretroviral treatment experience and CD4 cell count/viral load at start NVPc. Models were stratified by cohort and adjusted for age, sex, nadir CD4 cell count, calendar year of starting NVPc and mode of transmission. Results: Median time from starting NVPc to TOXPC and HSR were 162 days [interquartile range (IQR) 31 -737] and 30 days (IQR 17-60), respectively. In adjusted Cox analyses, compared to naive patients with a low CD4 cell count, treatment-experienced patients with high CD4 cell count and viral load more than 400 had a significantly increased risk for HSR [hazard ratio 1.45, confidence interval (CI) 1.03-2.03] and TOXPC within 18 weeks (hazard ratio 1.34, Cl 1.08-1.67). In contrast, treatment-experienced patients with high CD4 cell count and viral load less than 400 had no increased risk for HSR 1.10 (0.82-1.46) or TOXPC within 18 weeks(hazard ratio 0.94, Cl 0.78-1.13). Conclusion: Our results suggest it may be relatively well tolerated to initiate NVPc in anti retroviral-experienced patients with high CD4 cell counts provided there is no detectable viremia. (C) 2009 Wolters Kluwer Health | Lippincott Williams & WilkinsI documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
