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2488. Virologic Failure in ART Naïve Patients Initiating on a Dolutegravir or Elvitegravir-Based Regimen

BACKGROUND: Robust pharmacoeconomic modeling is dependent on high quality inputs, preferably from randomized clinical trials (RCT), but not all needed head to head comparisons occur in RCTs. We compared virologic outcomes in an antiretroviral (ART) naïve population initiating a dolutegravir (DTG) or...

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Autores principales: Wohlfeiler, Michael, Schulman, Kathy, Fusco, Jennifer S, Punekar, Yogesh, Mills, Anthony, Priest, Julie, Oglesby, Alan, Fusco, Gregory
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6809617/
http://dx.doi.org/10.1093/ofid/ofz360.2166
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author Wohlfeiler, Michael
Schulman, Kathy
Fusco, Jennifer S
Punekar, Yogesh
Mills, Anthony
Priest, Julie
Oglesby, Alan
Fusco, Gregory
author_facet Wohlfeiler, Michael
Schulman, Kathy
Fusco, Jennifer S
Punekar, Yogesh
Mills, Anthony
Priest, Julie
Oglesby, Alan
Fusco, Gregory
author_sort Wohlfeiler, Michael
collection PubMed
description BACKGROUND: Robust pharmacoeconomic modeling is dependent on high quality inputs, preferably from randomized clinical trials (RCT), but not all needed head to head comparisons occur in RCTs. We compared virologic outcomes in an antiretroviral (ART) naïve population initiating a dolutegravir (DTG) or elvitegravir (EVG)-based regimen using clinical trial-like criteria. METHODS: ART-naïve adults, initiating a DTG- or EVG-based regimen and meeting all study eligibility criteria (Figure 1) were identified in the OPERA® Observational Database, a collaboration of HIV caregivers following 100,000+ people living with HIV (PLWH) through electronic medical records. PLWH were followed from the date of first prescription until DTG- or EVG discontinuation, death, or study end (July 31, 2018). The primary outcome was verified (2 consecutive viral load (VL) ≥200 copies/mL or 1 VL ≥200 copies + discontinuation) virologic failure (VF), defined as either failure to achieve suppression (<50 copies/mL) prior to 36 weeks or failure to maintain suppression once achieved. Survival analyses were conducted with Kaplan–Meier methods and multivariate Cox Proportional Hazards modeling. RESULTS: A total of 1,688 (DTG) and 2,537 (EVG) met all eligibility criteria. Median (IQR) length of follow-up in the DTG users was 21 months (14–30), in the EVG users was 20 (14–32) months. Figure 2 characterizes baseline demographic/clinical characteristics. Figures 3 and 4 depict Kaplan–Meier curves and Cox model results, respectively. VF was experienced by 8.2% DTG and 10.9% EVG initiators at a rate (95% CI) per 1,000 person-years of 40.2 (33.8, 47.8) and 51.3 (45.3, 58.1), respectively. Younger age (18–25), being African American, having a baseline CD4 count ≤ 200, or having a government-based payer (ADAP, Ryan White, Medicaid, or Medicare) at baseline were associated with a significant (P < 0.05), increased hazard of VF. Initiating on DTG or initiating therapy with a lower baseline VL was associated with a significant, reduced hazard of VF. Compared with DTG, the adjusted hazard ratio for VF was 1.29 (95% CI: 1.02, 1.63) for EVG. CONCLUSION: Among ART-naïve patients, DTG users were significantly less likely to experience virologic failure than EVG users after adjustment for important baseline covariates. [Image: see text] [Image: see text] [Image: see text] [Image: see text] DISCLOSURES: All authors: No reported disclosures.
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spelling pubmed-68096172019-10-28 2488. Virologic Failure in ART Naïve Patients Initiating on a Dolutegravir or Elvitegravir-Based Regimen Wohlfeiler, Michael Schulman, Kathy Fusco, Jennifer S Punekar, Yogesh Mills, Anthony Priest, Julie Oglesby, Alan Fusco, Gregory Open Forum Infect Dis Abstracts BACKGROUND: Robust pharmacoeconomic modeling is dependent on high quality inputs, preferably from randomized clinical trials (RCT), but not all needed head to head comparisons occur in RCTs. We compared virologic outcomes in an antiretroviral (ART) naïve population initiating a dolutegravir (DTG) or elvitegravir (EVG)-based regimen using clinical trial-like criteria. METHODS: ART-naïve adults, initiating a DTG- or EVG-based regimen and meeting all study eligibility criteria (Figure 1) were identified in the OPERA® Observational Database, a collaboration of HIV caregivers following 100,000+ people living with HIV (PLWH) through electronic medical records. PLWH were followed from the date of first prescription until DTG- or EVG discontinuation, death, or study end (July 31, 2018). The primary outcome was verified (2 consecutive viral load (VL) ≥200 copies/mL or 1 VL ≥200 copies + discontinuation) virologic failure (VF), defined as either failure to achieve suppression (<50 copies/mL) prior to 36 weeks or failure to maintain suppression once achieved. Survival analyses were conducted with Kaplan–Meier methods and multivariate Cox Proportional Hazards modeling. RESULTS: A total of 1,688 (DTG) and 2,537 (EVG) met all eligibility criteria. Median (IQR) length of follow-up in the DTG users was 21 months (14–30), in the EVG users was 20 (14–32) months. Figure 2 characterizes baseline demographic/clinical characteristics. Figures 3 and 4 depict Kaplan–Meier curves and Cox model results, respectively. VF was experienced by 8.2% DTG and 10.9% EVG initiators at a rate (95% CI) per 1,000 person-years of 40.2 (33.8, 47.8) and 51.3 (45.3, 58.1), respectively. Younger age (18–25), being African American, having a baseline CD4 count ≤ 200, or having a government-based payer (ADAP, Ryan White, Medicaid, or Medicare) at baseline were associated with a significant (P < 0.05), increased hazard of VF. Initiating on DTG or initiating therapy with a lower baseline VL was associated with a significant, reduced hazard of VF. Compared with DTG, the adjusted hazard ratio for VF was 1.29 (95% CI: 1.02, 1.63) for EVG. CONCLUSION: Among ART-naïve patients, DTG users were significantly less likely to experience virologic failure than EVG users after adjustment for important baseline covariates. [Image: see text] [Image: see text] [Image: see text] [Image: see text] DISCLOSURES: All authors: No reported disclosures. Oxford University Press 2019-10-23 /pmc/articles/PMC6809617/ http://dx.doi.org/10.1093/ofid/ofz360.2166 Text en © The Author(s) 2019. Published by Oxford University Press on behalf of Infectious Diseases Society of America. http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle Abstracts
Wohlfeiler, Michael
Schulman, Kathy
Fusco, Jennifer S
Punekar, Yogesh
Mills, Anthony
Priest, Julie
Oglesby, Alan
Fusco, Gregory
2488. Virologic Failure in ART Naïve Patients Initiating on a Dolutegravir or Elvitegravir-Based Regimen
title 2488. Virologic Failure in ART Naïve Patients Initiating on a Dolutegravir or Elvitegravir-Based Regimen
title_full 2488. Virologic Failure in ART Naïve Patients Initiating on a Dolutegravir or Elvitegravir-Based Regimen
title_fullStr 2488. Virologic Failure in ART Naïve Patients Initiating on a Dolutegravir or Elvitegravir-Based Regimen
title_full_unstemmed 2488. Virologic Failure in ART Naïve Patients Initiating on a Dolutegravir or Elvitegravir-Based Regimen
title_short 2488. Virologic Failure in ART Naïve Patients Initiating on a Dolutegravir or Elvitegravir-Based Regimen
title_sort 2488. virologic failure in art naïve patients initiating on a dolutegravir or elvitegravir-based regimen
topic Abstracts
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6809617/
http://dx.doi.org/10.1093/ofid/ofz360.2166
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