Long-term durability of nevirapine-based ART in a cohort of 82 patients after induction with protease inhibitor treatment

Purpose of the study : There is still an open question how to start antiretro-viral therapy (ART). This retrospective study shows results of a de-escalation strategy starting with a protease inhibitor (PI), followed by a nevirapine-based regimen over a period of five years. Methods : All patients were ART-naive and received PI in combination with two NRTIs. The PI was changed to nevirapine, when viral load (VL) stayed at least 12 months below the detection limit (50 or 40 copies/ml plasma). The median time to negative VL was measured. CD4, VL and liver tests were followed in 82 patients over at least 5 years before ART, during PI phase and over a median of 48 months after change to nevirapine. Resistance tests were performed - if possible - in patients before initiating ART. Summary of results : 20 female and 62 male patients were treated for an average of 28 months with PI (43× lopinavir, 5× indinavir, 6× invirase/r and 3× fortovase/r, 8× nelfinavir, 14× atazanavir/r, 3× norvir-mono plus two backbone NRTI in various combinations). There were 2 cases of hepatitis B and 5 HCV positives in the cohort. The mean CD4 before starting ART was 246/μl and the average VL was 421,038 copies/ml plasma (ranging from 1,050 - 9,000,000 copies/ml plasma). The median time to negative VL was 188 days. CD4 cells were rising by 364/μl during PI treatment to 610/μl. This was followed by a steady increase of another 70 cells/μl during the first year after changing to nevirapine. The median follow up after de-escalation to nevirapine was 48 months. Although the median CD4 was above 400/μl in all patients when changed to nevirapine, no severe liver toxicity was seen in the cohort. Change to NNRTI was safe in the group of 20 women with CD4 cells above 400/μl. Allergic skin reactions where seen in 7 out of 82 patients during the first 3 months after changing to nevirapine. No events of resistancies were seen in the group of 82 patients before and under treatment. Conclusions : Long-term durability of nevirapine containing ART regimens following an induction phase with PIs is very high. No risk of treatment failure by resistance mutations was seen in a follow up of more than 48 months. Liver toxicity was not seen when ART was changed to nevirapine neither in female nor in male patients. The study was supported by Boehringer Ingelheim Pharma GmbH. (Published: 11 November 2012) Citation: Abstracts of the Eleventh International Congress on Drug Therapy in HIV Infection Rump J et al. Journal of the International AIDS Society 2012, 15 (Suppl 4):18247 http://www.jiasociety.org/index.php/jias/article/view/18247 | http://dx.doi.org/10.7448/IAS.15.6.18247