Cost Considerations in the Current Antiretroviral Era

Ellen F. Eaton; Ashutosh Tamhane; Michael Saag; Michael J. Mugavero; Meredith L. Kilgore

Disclosures

AIDS. 2016;30(14):2115-2119. 

In This Article

Abstract and Introduction

Abstract

Background: US national guidelines call for cost-conscious practices including the selection of antiretroviral therapy.

Objective: The objective is to analyze the relative cost-effectiveness of contemporary antiretroviral therapy in real-world clinical settings.

Design: Observational cohort study.

Methods: Retrospective follow-up study of treatment-naïve persons living with HIV initiating antiretroviral therapy (ART) between January 2007 and December 2012 at an academically affiliated HIV clinic was conducted. Analysis was restricted to patients with the five most commonly prescribed regimens (N = 491). Patients were followed until December 14 to determine the durability of the initial regimen prescribed; median durations were calculated using Kaplan–Meier survival analyses. The average 340b price of the ART regimen 30-day supply was used for cost. Sensitivity analyses were performed adjusting for missing data and pricing indices and using mean durability (±1 SD).

Results: Initial regimens contained emtricitabine and tenofovir, along with a third drug. Median durability was shortest for ritonavir-boosted atazanavir (31.9 months) and longest for ritonavir-boosted darunavir and raltegravir (both 47.8 months). All regimens were dominated, meaning less durable and more costly, relative to efavirenz ($710.64/month) and raltegravir-based regimens ($1075.03/month). These findings were reproduced in sensitivity analysis, although rilpivirine became a valuable option in some scenarios. Relative to the efavirenz-based regimen, raltegravir had an incremental cost of $47/month of additional therapy.

Conclusion: In this sample, raltegravir and efavirenz-based regimens are the most cost-effective options for treatment-naive patients. Sensitivity analyses suggest rilpivirine is a reasonable choice in limited scenarios. These findings are relevant given changes in recommended regimens for treatment-naive persons, which include raltegravir and darunavir but exclude efavirenz and rilpivirine-based regimens.

Summary: Of five commonly prescribed regimens for treatment-naïve HIV patients in one clinic (2007–2012), emtricitabine and tenofovir with efavirenz and raltegravir were the only consistently cost-effective options; the rilpivirine-based regimen was valuable in limited scenarios. Further data on the comparative effectiveness of efavirenz and rilpivirine are needed before they are abandoned.

Introduction

Antiretroviral therapy (ART) has improved morbidity and mortality for persons living with HIV (PLWH).[1] Currently, there are many effective regimens for treatment-naïve PLWH.[2] In addition to efficacy, antiretroviral durability, defined as the time from regimen initiation to discontinuation, has been associated with improved clinical outcomes.[3] Durability was adopted early in the ART era as an indirect measure of effectiveness and tolerability.

Perceptions of ART durability and preferred regimens are ever changing. Efavirenz has fallen from favor following reports of increased suicidality in clinical trials.[4,5] Similarly, rilpivirine, the backbone of a once preferred single-tablet regimen, is now known to have limited efficacy in those with a high HIV RNA viral load. Owing to these limitations and the availability of alternative, tolerable options, efavirenz (Atripla) and rilpivirine (Complera) are no longer recommended as first-line therapy for treatment-naive PLWH.[6] Both were downgraded to the 'alternative' category by the 2015 Department of Health and Human Services (DHHS) Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. Of note, the striking number of efavirenz-related suicidality events reported in mostly open-label clinical trials was not reproduced in large observational studies.[7,8] With increasing ART options and an evolving treatment landscape, understanding comparative effectiveness is essential.

ART is cost-effective, but it is costly and constitutes over 70% of comprehensive HIV healthcare expenses.[9,10] Recently, the DHHS asked providers to educate themselves on antiretroviral regimen costs and generic antiretroviral availability.[6] Nonetheless, the five regimens recommended for treatment-naive patients, according to the DHHS panel, include the most expensive, least cost-effective options.[6,11,12] Alternatively, Atripla and Complera, both downgraded to 'alternative' options, have been shown to be the most cost-effective options.[12,13] Although there is a growing demand for cost-conscious HIV care, there is little data on relative cost-effectiveness of contemporary antiretroviral regimens, and current guidelines do not incorporate cost considerations in the selection of preferred treatment regimens. We, therefore, analyzed the cost and utility of contemporary antiretroviral regimens in a real-world, clinical setting.

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