Darunavir outcomes study: comparative effectiveness of virologic suppression, regimen durability, and discontinuation reasons for three-class experienced patients at 48 weeks.
Several new antiretroviral (ARV) agents for treatment experienced HIV-infected patients have been approved since June 2006, including darunavir (DRV) and raltegravir (RAL). While efficacious in clinical trials, the effectiveness, durability, and tolerability of these new ARVs remains understudied in the context of routine clinical care. The Darunavir Outcomes Study is a prospective cohort study of three-class ARV-experienced patients changing regimens at the 1917 Clinic after 1/7/2006. All treatment decisions were at the discretion of primary providers. Multivariate (MV) logistic regression for 48 week VL < 400c/ml and Cox models for regimen durability were completed. Propensity score methods controlled for sociodemographics. Among 108 patients, mean age of 46, 48% were white, 80% male, with prior exposure to a mean 10.5 ARVs. Overall, 64% of patients achieved 48-week VL < 400 c/ml. In MV modeling DRV/rll (OR = 5.77;95%CI = 1.62-20.58) and RAL (OR = 3.84;95%CI = 1.23-11.95) use increased odds of 48-week suppression. Use of these agents exhibited a trend towards prolonged regimen durability in Cox models. Among those highly ARV-experienced, regimens containing DRV/r and/or RAL were more likely to achieve 48-week VL < 400 c/ml and exhibited a trend towards prolonged durability. New agents have transformed the treatment landscape for ARV-experienced patients, with effectiveness in routine clinical care mirroring efficacy in clinical trials.
Division of Infectious Diseases, Department of Internal Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA. jwillig@uab.edu
James H
JH
Willig
Inmaculada
I
Aban
Christa R
CR
Nevin
Jiatao
J
Ye
James L
JL
Raper
James A
JA
McKinnel
Lori L
LL
Delaitsch
Joseph M
JM
Mrus
Guy R
GR
De La Rosa
Michael J
MJ
Mugavero
Michael S
MS
Saag
D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000009:adverse effects*; D015331:Cohort Studies; D000069454:Darunavir; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013449:Sulfonamides / Q000008:administration & dosage* / Q000009:adverse effects*; D016896:Treatment Outcome; D016903:Drug Monitoring
D019380:Anti-HIV Agents; D013449:Sulfonamides; D000069454:Darunavir