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Comparative Study
. 2017 Jan;37(1):51-60.
doi: 10.1007/s40261-016-0456-1.

Virologic Effectiveness of Abacavir/Lamivudine with Darunavir/Ritonavir Versus Other Protease Inhibitors in Treatment-Experienced HIV-Infected Patients in Clinical Practice

Philip Lackey  1   2 , Anthony Mills  2   3 , Felix Carpio  2   4 , Ricky Hsu  5 , Edwin DeJesus  2   6 , Gerald Pierone  2   7 , Cassidy Henegar  8 , Jennifer Fusco  2   9 , Gregory Fusco  2 , Mike Wohlfeiler  2   10
Affiliations
Comparative Study

Virologic Effectiveness of Abacavir/Lamivudine with Darunavir/Ritonavir Versus Other Protease Inhibitors in Treatment-Experienced HIV-Infected Patients in Clinical Practice

Philip Lackey et al. Clin Drug Investig. 2017 Jan.

Abstract

Background and objectives: The standard of care for HIV treatment is a three-drug regimen consisting of two nucleoside reverse transcriptase inhibitors (NRTIs) and either a non-nucleoside reverse transcriptase inhibitor, a protease inhibitor (PI) or an integrase strand transfer inhibitor. Darunavir boosted with ritonavir (DRV/r) is the only preferred PI in the US Department of Health and Human Services (DHHS) HIV treatment guidelines for antiretroviral-naïve patients, recommended in combination with tenofovir/emtricitabine for antiretroviral-naïve patients. For treatment-experienced and certain antiretroviral-naïve patients, abacavir and lamivudine (ABC/3TC) in combination with DRV/r is considered an effective and tolerable alternative, despite limited research on the effectiveness of this particular combination. This study evaluated virologic outcomes in treatment-experienced patients taking ABC/3TC + DRV/r compared to treatment-experienced patients taking ABC/3TC with any other PI.

Methods: Treatment-experienced HIV-infected patients initiating their first regimen containing ABC/3TC in combination with any PI in the year 2005 or later were selected from the Observational Pharmaco-Epidemiology Research and Analysis (OPERA®) cohort, a prospective observational cohort reflecting routine medical care. Viral load measurements taken during follow-up were compared between patients taking ABC/3TC + DRV/r and ABC/3TC with a PI other than DRV/r. Logistic regression models were fit to assess the association between regimen exposure and viral load suppression.

Results: A total of 151 patients initiating ABC/3TC + DRV/r and 525 patients initiating ABC/3TC + a non-darunavir PI were included. Patients in both treatment groups had comparable clinical indicators (viral load, CD4) at baseline. A regimen of ABC/3TC + DRV/r was more likely to be prescribed in the later years of the study period, leading to a shorter median follow-up in the DRV/r treatment group (as-treated analysis: 14 vs. 17 months, p = 0.04; intent-to-treat analysis: 33 vs. 68 months, p < 0.001). Multivariable logistic regression models accounting for year of regimen initiation, among other factors, indicated no statistically significant differences in achieving an undetectable viral load for patients taking DRV/r with ABC/3TC compared with other PIs, both in the as-treated (odds ratio [95 % confidence interval]: 0.84 [0.53-1.34]) and intent-to-treat analyses (0.82 [0.48-1.40]). Patients in both treatment groups also showed similar reductions in viral load (median darunavir vs. non-darunavir: -23.0 vs. -23.0 copies/mL; p = 0.72) and gains in CD4 T cell counts (median darunavir vs. non-darunavir: 106 vs. 108 cells/mm3; p = 0.59] while being treated with the regimen of interest.

Conclusions: Patients receiving ABC/3TC + DRV/r appear to experience similar treatment benefit to patients taking ABC/3TC with other PIs in terms of achieving suppression, as well as absolute reductions in viral load and CD4 lymphocyte gains.

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Conflict of interest statement

Compliance with Ethical Standards Funding This work was support by a project grant from ViiV Healthcare, which was performed using Epividian’s OPERA® database. ViiV Healthcare had no editorial control in the content of this article or involvement in the design, conduct, analysis, and interpretation of this study. Conflicts of interest Philip Lackey is a member of the OPERA® Clinical and Epidemiological Advisory Board. Anthony Mills has received research support and served as a consultant for Gilead Sciences, Merck, ViiV Healthcare, EMD Serono, and Bristol-Myers Squibb, and has received lecture fees from Gilead Sciences, ViiV Healthcare, and Merck. He is also a member of the OPERA® Clinical and Epidemiological Advisory Board. Felix Carpio is a member of the OPERA® Clinical and Epidemiological Advisory Board. Ricky Hsu has received research support from Gilead Sciences, and has served as a consultant and received lecture honoraria from Gilead Sciences, ViiV Healthcare, Janssen, Bristol-Myers Squibb, and AbbVie. Edwin DeJesus is a member of the OPERA® Clinical and Epidemiological Advisory Board. Gerald Pierone is a member of the OPERA® Clinical and Epidemiological Advisory Board. Cassidy Henegar is an employee of Epividian. Jennifer Fusco is an employee of Epividian and a member of the OPERA® Clinical and Epidemiological Advisory Board. Gregory Fusco is chairperson for the OPERA® Clinical and Epidemiological Advisory Board. Michael Wohlfeiler has served as a consultant for ViiV Healthcare, and has received lecture honoraria from EMD Serono and Gilead Sciences. He is also a member of the OPERA® Clinical and Epidemiological Advisory Board. Ethical approval All procedures in this study were in accordance with the 1964 Helsinki Declaration (and its amendments). No approval by ethical committee or institutional review board was needed. Analysis was performed on de-identified patient data collected for routine clinical purposes.

Figures

Fig. 1
Fig. 1
Selection of eligible patients for primary analysis. ABC/3TC abacavir/lamivudine, ARVs antiretrovirals, DRV/r darunavir boosted with ritonavir, OPERA Observational Pharmaco-Epidemiology Research and Analysis, PI protease Inhibitor
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