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AIDS. 2009 Aug 24;23(13):1689-99. doi: 10.1097/QAD.0b013e32832d3b54.

Risk factors for treatment-limiting toxicities in patients starting nevirapine-containing antiretroviral therapy.

Collaborators (435)

Bronsveld W, Hillebrand-Haverkort ME, Prins JM, Bos JC, Eeftinck Schattenkerk JK, Geerlings SE, Godfried MH, Lange JM, van Leth FC, Lowe SH, van der Meer JT, Nellen FJ, Pogány K, van der Poll T, Reiss P, Ruys TA, Sankatsing, Steingrover R, vanTwillert G, van der Valk M, van Vonderen MG, Vrouenraets SM, van Vugt M, Wit FW, van Eeden A, ten Veen JH, van Dam PS, Roos JC, Brinkman K, Frissen PH, Weigel HM, Mulder JW, van Gorp EC, Meenhorst PL, Mairuhu AT, Veenstra J, Danner SA, Van Agtmael MA, Claessen FA, Perenboom RM, Rijkeboer A, van Vonderen M, Richter C, van der Berg J, van Leusen R, Vriesendorp R, Jeurissen FJ, Kauffman RH, Koger EL, HAGA, Bravenboer B, ten Napel CH, Kootstra GJ, Sprenger HG, Miesen WM, Doedens R, Scholvinck EH, ten Kate RW, van Houte DP, Polee M, Kroon FP, van den Broek, van Dissel JT, Schippers EF, Schreij G, van de Geest S, Verbon A, Koopmans PP, Keuter M, Post F, van der Ven AJ, van der Ende ME, Gyssens IC, van der Feltz M, den Hollander JG, de Marie S, Nouwen JL, Rijnders BJ, de Vries TE, Juttmann JR, van de Heul C, van Kasteren ME, Schneider MM, Bonten MJ, Borleffs JC, Ellerbroek PM, Hoepelman IM, Jaspers CA, Schouten I, Schurink CA, Blok WL, Tanis AA, Groeneveld PH, Alexander C, Barrios R, Braitstein P, Brumme Z, Chan K, Cote H, Gataric N, Geller J, Guillemi S, Richard Harrigan P, Harris M, Hogg R, Joy R, Levy A, Montaner J, Montessori V, Palepu A, Phillips E, Phillips P, Press N, Tyndall M, Wood E, Yip B, Losso M, Elias C, Vetter N, Zangerle R, Karpov I, Vassilenko A, Mitsura VM, Suetnov O, De Wit S, Delforge M, Clumeck N, Colebunders R, Vandekerckhove L, Hadziosmanovic V, Kostov K, Begovac J, Machala L, Rozsypal H, Sedlacek D, Nielsen J, Kronborg G, Benfield T, Larsen M, Gerstoft J, Katzenstein T, Hansen AB, Pedersen C, Oestergaard L, Zilmer K, Ristola M, Katlama C, Girard JP, Livrozet JM, Vanhems P, Pradier C, Dabis F, Neau D, Rockstroh J, Schmidt R, van Lunzen J, Degen O, Stellbrink HJ, Staszewski S, Bogner J, Fätkenheuer G, Kosmidis J, Gargalianos P, Xylomenos G, Perdios J, Panos G, Filandras A, Karabatsaki E, Sambatakou H, Banhegyi D, Mulcahy F, Yust I, Turner D, Burke M, Pollack S, Hassoun G, Maayan S, Chiesi A, Esposito R, Mazeu I, Mussini C, Arici C, Pristera R, Mazzotta F, Gabbuti A, Vullo V, Lichtner M, Chirianni A, Montesarchio E, Gargiulo M, Antonucci G, Iacomi F, Narciso P, Vlassi C, Zaccarelli M, Lazzarin A, Finazzi R, Galli M, Ridolfo A, d'Arminio Monforte A, Rozentale B, Aldins P, Chaplinskas S, Hemmer R, Staub T, Reiss P, Bruun J, Maeland A, Ormaasen V, Knysz B, Horban A, Bakowska E, Prokopowicz D, Flisiak R, Boron-Kaczmarska A, Pynka M, Beniowski M, Mularska E, Trocha H, Jablonowska E, Malolepsza E, Wojcik K, Antunes F, Valadas E, Mansinho K, Maltez F, Duiculescu D, Babes V, Rakhmanova A, Vinogradova A, Buzunova S, Jevtovic D, Mokrás M, Staneková D, Tomazic J, González-Lahoz J, Soriano V, Martin-Carbonero L, Labarga P, Moreno S, Clotet B, Jou A, Paredes R, Tural C, Puig J, Bravo I, Gatell JM, Miró JM, Domingo P, Gutierrez M, Mateo G, Sambeat MA, Karlsson A, Persson PO, Flamholc L, Ledergerber B, Weber R, Francioli P, Cavassini M, Hirschel B, Boffi E, Furrer H, Battegay M, Elzi L, Kravchenko E, Chentsova N, Kutsyna G, Servitskiy S, Antoniak S, Krasnov M, Barton S, Johnson AM, Mercey D, Phillips A, Johnson MA, Murphy M, Weber J, Scullard G, Fisher M, Leen C, Clotet B, Paredes R, Antunes F, Clotet B, Duiculescu D, Gatell J, Gazzard B, Horban A, Karlsson A, Katlama C, Ledergerber B, D'Arminio Montforte A, Phillips A, Rakhmanova A, Reiss P, Rockstroh J, Lundgren J, Kirk O, Mocroft A, Friis-Møller N, Cozzi-Lepri A, Bannister W, Ellefson M, Borch A, Podlekareva D, Kjaer J, Peters L, Reekie J, Kowalska J, Perez I, Gatell J, Gill J, Read R, Krentz H, Beckthold B, Battegay M, Bernasconi E, Böni J, Bucher HC, Bürgisser P, Calmy A, Cattacin S, Cavassini M, Dubs R, Egger M, Elzi L, Erb P, Fischer M, Flepp M, Fontana A, Francioli P, Furrer H, Fux C, Gorgievski M, Günthard H, Hirsch H, Hirschel B, Hösli I, Kahlert Ch, Kaiser L, Karrer U, Kind C, Klimkait T, Ledergerber B, Martinetti G, Martinez B, Müller N, Nadal D, Opravil M, Paccaud F, Pantaleo G, Rauch A, Regenass S, Rickenbach M, Rudin C, Schmid P, Schultze D, Schüpbach J, Speck R, Taffé P, Tarr P, Telenti A, Trkola A, Vernazza P, Weber R, Yerly S, Phillips AN, Gilson R, Easterbrook P, Fisher M, Gazzard B, Johnson M, Walsh J, Leen C, Orkin C, Anderson J, Pillay D, Delpech V, Schwenk A, Dunn D, Gompels M, Hill T, Porter K, Babiker A, Sabin C, Bansi L, Hill T, Phillips A, Sabin C, Babiker A, Dunn D, Porter K, Sheehan S, Easterbrook P, Waters A, Crates D, Mohamed-Saad S, Fisher M, Perry N, Pullin A, Churchill D, Harris W, Gazzard B, Bulbeck S, Mandalia S, Clarke J, Gilson R, Dodds J, Rider A, Williams I, Delpech V, Johnson M, Youle M, Lampe F, Smith C, Gumley H, Chaloner C, Puradiredja DI, Walsh J, Weber J, Cashin S, Kemble C, Mackie N, Winston A, Orkin C, Thomas R, Jones K, Anderson J, Gann S, Jones K, Leen C, Wilson A, Schwenk A, Ainsworth J, Gompels M.

Author information

  • 1HIV Monitoring Foundation, The Netherlands.

Abstract

BACKGROUND:

This collaboration of seven observational clinical cohorts investigated risk factors for treatment-limiting toxicities in both antiretroviral-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/microl/>250/microl 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, CI 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, CI 0.78-1.13).

CONCLUSION:

Our results suggest it may be relatively well tolerated to initiate NVPc in antiretroviral-experienced patients with high CD4 cell counts provided there is no detectable viremia.

Comment in

PMID:
19487907
[PubMed - indexed for MEDLINE]
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