Funding is also provided by the National Institute of Child Health and Human Development (U01-HD-32632) and the National Center for Research Resources (M01-RR-00071, M01-RR-00079 and M01-RR-00083). The Cost-Effectiveness of Preventing AIDS Complications (CEPAC) investigators include: Massachusetts General Hospital, Boston, MA, USA:
John J. Chiosi, Sarah Chung, Andrea L. Ciaranello, Kenneth A. Freedberg, Heather E. Hsu, Elena Losina, Zhigang Lu, Caroline Sloan, Stacie Waldman, Rochelle P. Walensky, PKC412 manufacturer Bingxia Wang, Angela Wong and Hong Zhang; Brigham and Women’s Hospital, Boston, MA, USA: Paul E. Sax; Harvard School of Public Health, Boston, MA, USA: Sue J. Goldie, April D. Kimmel, Kara L. Cotich, Marc Lipsitch, Chara E. Rydzak, George R. Seage III and Milton C. Weinstein; Yale School of Medicine, New Haven, CT, USA: A. David Paltiel; Weill Cornell Medical College, New York City, NY, USA: Bruce R. Schackman. “
“Nucleoside reverse transcriptase inhibitor (NRTI)-sparing regimens may be needed in patients with NRTI toxicity. Maraviroc (MVC) plus ritonavir-boosted darunavir (DRV-r) or atazanavir is associated with slightly lower response rates than triple therapy in drug-naïve patients. No information is available on these combinations
in pretreated patients. The aim of this study was to assess the efficacy MLN0128 and safety of MVC plus DRV/r once-daily (qd) in HIV-infected pretreated patients. A retrospective cohort study including patients starting MVC 150 mg plus DRV/r 800/100 mg qd, with CCR5 tropism and no resistance mutations for DRV/r, was performed. The primary to efficacy endpoint was the achievement of plasma HIV RNA < 50 HIV-1 RNA copies/mL after 48 weeks. The frequency of serious adverse effects was investigated. Sixty
patients were recruited to the study, of whom 48 (80%) had HIV RNA < 50 copies/mL at baseline. Reasons for starting MVC plus DRV/r were: adverse effects in 38 individuals (63%), simplification in 15 (25%) and virological failure in seven (12%). The main analysis (intention to treat, noncompleter = failure) showed that 47 patients (78%) achieved HIV RNA < 50 copies/mL at 48 weeks (paired comparison with baseline, P = 1.0). On-treatment analysis showed that 42 (86%) of 49 patients presented HIV RNA < 50 copies/mL at 48 weeks (paired comparison with baseline, P = 1.0). Median (interquartile range) CD4 cell counts increased from 491 (301−729) to 561 (367−793) cells/μL at 48 weeks (P = 0.013). Only one patient discontinued therapy because of adverse effects. Most individuals starting MVC plus DRV/r qd because of simplification or adverse effects maintained HIV suppression after 48 weeks of follow-up.