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Trends in antiretroviral therapy prescription, durability and modification: new drugs, more changes, but less failure.

ABSTRACT: OBJECTIVE:To evaluate the real world durability of contemporary ART for treatment-naïve people living with HIV (PLWH). DESIGN:A retrospective follow-up study in a multisite cohort. METHODS:This study of the CNICS (CFAR Network of Integrated Clinical Systems) cohort integrates data from eight Center for AIDS Research (CFARs). PLWH initiating ART between 2007 and 2014 were included. Durability was defined as time from the initiation until discontinuation/modification using Kaplan-Meier survival curves. Cox Proportional Hazards measured associations with various sociodemographic and clinical characteristics. RESULTS:Among 5373 PLWH, the initial regimen was modified in 2285 (43%) patients. Efavirenz/emtricitabine/tenofovir (n?=?2173, 40%) was the most commonly prescribed initial ART regimen; elvitegravir/cobicistat/emtricitabine/tenofovir became more common after 2012. Median durability for all regimens was 48.6 months. There were statistically significant differences in median durability for NNRTI, InSTI, and protease inhibitor-based regimens, which lasted 61, 44, and 32 months, respectively. Female sex (aHR?=?1.4; 95% CI 1.2-1.6), intravenous drug use (aHR?=?1.6; 95% CI 1.3-1.9), and CD4 cell count less than 200 cells/?l (aHR?=?1.2; 95% CI 1.1-1.3) were significantly associated with regimen modification. Compared with InSTI, those receiving an InSTI/protease inhibitor (aHR?=?2.7; 95% CI 2.0-3.7) or protease inhibitor-based ART (aHR?=?1.9; 95% CI 1.6-2.2) were significantly more likely to be modified; but those receiving NNRTI (aHR?=?1.1; 95% CI 0.9-1.3) were not. CONCLUSION:In treatment-naive PLWH, NNRTI and InSTI-based ART were most durable, relative to protease inhibitor and InSTI/protease inhibitor-based ART, and were least likely to be modified/discontinued. A greater understanding of reasons for regimen modification/discontinuation is needed to analyze contemporary regimen durability.

SUBMITTER: Eaton EF

PROVIDER: S-EPMC6604808 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature

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Trends in antiretroviral therapy prescription, durability and modification: new drugs, more changes, but less failure.

Eaton Ellen F EF Tamhane Ashutosh A Davy-Mendez Thibaut T Mathews William C WC Moore Richard D RD Saag Michael S MS Mugavero Michael J MJ

AIDS (London, England) 20180101 3

<h4>Objective</h4>To evaluate the real world durability of contemporary ART for treatment-naïve people living with HIV (PLWH).<h4>Design</h4>A retrospective follow-up study in a multisite cohort.<h4>Methods</h4>This study of the CNICS (CFAR Network of Integrated Clinical Systems) cohort integrates data from eight Center for AIDS Research (CFARs). PLWH initiating ART between 2007 and 2014 were included. Durability was defined as time from the initiation until discontinuation/modification using Ka ...[more]

PMID: 29194118

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Project description:ImportanceHigh and continually increasing pharmaceutical drug spending is a major health and health policy concern in the United States.ObjectiveTo demonstrate trends in prices among popular brand-name prescription drugs.Design, setting, and participantsThis economic evaluation of drug prices focuses on 49 top-selling brand-name medications in the United States. Pharmacy claims data from January 1, 2012, through December 31, 2017, were obtained from Blue Cross Blue Shield Axis, a database that includes data from more than 35 million individuals with private pharmaceutical insurance. Drugs that exceeded $500 million in US sales or $1 billion in worldwide sales were examined.Main outcomes and measuresThe median sum of out-of-pocket and insurance costs paid by patients or insurers for common prescriptions, presented annually and monthly, was the primary outcome.ResultsIn total, 132 brand-name prescription drugs were identified in 2017 that met the inclusion criteria. Of this total, the study focused on 49 top-selling drugs that exceeded 100 000 pharmacy claims. Substantial cost increases among these drugs was near universal, with a 76% median cost increase from January 2012 through December 2017, and almost all drugs (48 [98%]) displaying regular annual or biannual price increases. Of the 36 drugs that have been available since 2012, 28 (78%) have seen an increase in insurer and out-of-pocket costs by more than 50%, and 16 (44%) have more than doubled in price. Insulins (ie, Novolog, Humalog, and Lantus) and tumor necrosis factor inhibitors (ie, Humira and Enbrel) demonstrated highly correlated price increases, coinciding with some of the largest growth in drug costs. Relative price changes did not differ between drugs that entered the market in the past 3 to 6 years and those that have been on the market longer (number of drugs, 13 vs 36; median, 29% increase from January 2015 through December 2017; P = .81) nor between drugs with or without a Food and Drug Administration-approved therapeutic equivalent (number of drugs, 17 vs 32; median, 79% vs 73%; P = .21). Changes in prices paid were highly correlated with third-party estimates of changes in drug net prices (ρ = 0.55; P = 3.8 × 10-5), suggesting that the current rebate system, which incentivizes high list prices and greater reliance on rebates, increases overall costs.Conclusions and relevanceThe growth of drug spending in the United States associated with government-protected market exclusivity is likely to continue; greater price transparency is warranted.

Dataset Information

Trends in antiretroviral therapy prescription, durability and modification: new drugs, more changes, but less failure.

Publications

Trends in antiretroviral therapy prescription, durability and modification: new drugs, more changes, but less failure.

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