Cost-Utility Analysis of Lopinavir/Ritonavir versus Atazanavir + Ritonavir Administered as First-Line Therapy for the Treatment of HIV Infection in Italy: From Randomised Trial to Real World

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Abstract

Objective

To estimate the lifetime cost utility of two antiretroviral regimens (once-daily atazanavir plus ritonavir [ATV+r] versus twice-daily lopinavir/ritonavir [LPV/r]) in Italian human immunodeficiency virus (HIV)-infected patients naïve to treatment.

Design

With this observational retrospective study we collected the clinical data of a cohort of HIV-infected patients receiving first-line treatment with LPV/r or ATV+r.

Methodology

A Markov microsimulation model including direct costs and health outcomes of first- and second-line highly active retroviral therapy was developed from a third-party (Italian National Healthcare Service) payer’s perspective. Health and monetary outcomes associated with the long-term use of ATV+r and LPV/r regimens were evaluated on the basis of eight health states, incidence of diarrhoea and hyperbilirubinemia, AIDS events, opportunistic infections, coronary heart disease events and, for the first time in an economic evaluation, chronic kidney disease (CKD) events. In order to account for possible deviations between real-life data and randomised controlled trial results, a second control arm (ATV+r 2) was created with differential transition probabilities taken from the literature.

Results

The average survival was 24.061 years for patients receiving LPV/r, 24.081 and 24.084 for those receiving ATV+r 1 and 2 respectively. The mean quality-adjusted life-years (QALYs) were higher for the patients receiving LPV/r than those receiving ATV+r (13.322 vs. 13.060 and 13.261 for ATV+r 1 and 2). The cost-utility values were 15,310.56 for LPV/r, 15,902.99 and 15,524.85 for ATV+r 1 and 2.

Conclusions

Using real-life data, the model produced significantly different results compared with other studies. With the innovative addition of an evaluation of CKD events, the model showed a cost-utility value advantage for twice-daily LPV/r over once-daily ATV+r, thus providing evidence for its continued use in the treatment of HIV.

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Most cited references 13

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Modelling in economic evaluation: an unavoidable fact of life.

M Buxton, M F Drummond, B A van Hout … (2015)

The role of modelling in economic evaluation is explored by discussing, with examples, the uses of models. The expanded use of pragmatic clinical trials as an alternative to models is discussed. Some suggestions for good modelling practice are made.

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Health-related quality of life and health care costs in severe, refractory irritable bowel syndrome.

B Tomenson, E Guthrie, Clovis Palmer … (2001)

The irritable bowel syndrome (IBS) may lead to considerable impairment of health-related quality of life and high health care costs. It is not clear whether these poor outcomes directly result from severe bowel symptoms or reflect a coexisting psychiatric disorder. To determine whether bowel symptom severity and psychological symptoms directly influence health-related quality of life and health care costs. Cross-sectional survey. Secondary and tertiary gastroenterology clinics. 257 patients with severe IBS who did not respond to usual treatments and were recruited for a trial of psychological treatment. Predictors were abdominal pain, entries in a diary of 10 IBS symptoms, and measures of psychological symptoms. Outcomes were inability to work, health-related quality of life (measured by Medical Outcomes Survey 36-item short-form questionnaire [SF-36] physical component summary scores), and health care and productivity costs. Predictor and outcome measures were compared by using multiple regression and logistic regression analyses. Abdominal pain occurred on average 24 days per month and activities were restricted on 145 days of the previous 12 months. The mean (+/-SD) Hamilton depression score was 11.3 +/- 6.1. The SF-36 physical component summary score was low (37.7 +/- 10.6), and the patients had incurred high health care costs ($1743 +/- $2263) over the previous year. Global severity and somatization scores on the Symptom Checklist 90 Revised, abdominal pain, and Hamilton depression scores independently contributed to the physical component score of the SF-36 (adjusted R(2) = 35.2%), but only psychological scores were associated with disability due to ill health. These variables did not accurately predict health care or other costs (adjusted R(2) = 9.3%). History of sexual abuse was not an independent predictor of outcome. Both abdominal and psychological symptoms are independently associated with impaired health-related quality of life in patients with severe IBS. Optimal treatment is likely to require a holistic approach. Since health care and loss of productivity costs are not clearly associated with these symptoms, alleviation of them will not necessarily lead to reduced costs.

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Impact of irritable bowel syndrome on quality of life.

Lachlan W. Whitehead, John C Burnett, Charles Cook … (1996)

The aims of this study were to determine the impact of irritable bowel syndrome on quality of life using a well-standardized measure, the SF-36, and to determine whether apparent impairments may be due to neuroticism. Undergraduate students with irritable bowel syndrome who had consulted a physician (41 females, 42 males), students with irritable bowel who had not consulted a physician (91 females, 74 males), and asymptomatic controls (52 females, 70 males) completed questionnaires on quality of life, neuroticism, and psychological distress. Patients showed greater impairment in quality of life than nonconsulters, who in turn showed greater impairment than controls. Neuroticism and psychological distress were correlated with all quality-of-life measures. However, when neuroticism and psychological distress were statistically partialed out, irritable bowel syndrome still had a significant negative impact. The SF-36 may be a useful outcome measure in treatment studies, but investigators will need to correct for confounding influences of neuroticism.

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Author and article information

Contributors

Maarten Postma: Role: Editor

Journal

Journal ID (nlm-ta): PLoS One

Journal ID (iso-abbrev): PLoS ONE

Journal ID (publisher-id): plos

Journal ID (pmc): plosone

Title: PLoS ONE

Publisher: Public Library of Science (San Francisco, USA )

ISSN (Electronic): 1932-6203

Publication date Collection: 2013

Publication date (Electronic): 27 February 2013

Volume: 8

Issue: 2

Electronic Location Identifier: e57777

Affiliations

[1 ]CREMS (Centre for Research on Health Economics, Social and Health Care Management), University Carlo Cattaneo - LIUC, Castellanza, Varese, Italy

[2 ]Department of Infectious and Tropical Diseases, A. Manzoni Hospital, Lecco, Italy

[3 ]First and Second Departments of Infectious Diseases, L. Sacco Hospital Authority, Milan, Italy

[4 ]Department of Occupational Health Clinica L. Devoto Labour, Section of Medical Statistics and Biometry G.A. Maccacaro, Faculty of Medicine and Surgery, University of Milan, Milan, Italy

[5 ]Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

Groningen Research Institute of Pharmacy, United States Of America

Author notes

* E-mail: urestelli@ 123456liuc.it

Competing Interests: An unconditional grant was received by Abbott Italy, to cover the costs for the reprocessing of data. This does not alter the authors' adherence to all the PLOS ONE policies on sharing data and materials.

Critical revision of the article: GR FS DC. Conceived and designed the experiments: EF PB GR EB ER EP DC. Performed the experiments: EF EB UR FS. Analyzed the data: EF PB GR UR ER EP FS DC. Wrote the paper: EF PB EB UR ER EP.

Article

Publisher ID: PONE-D-12-10343

DOI: 10.1371/journal.pone.0057777

PMC ID: 3584032

PubMed ID: 23460905

SO-VID: 5b053144-8cd7-4c25-8f24-058a00bc9bbc

License:

This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

History

Date received : 11 April 2012

Date accepted : 29 January 2013

Page count

Pages: 10

Funding

An unconditional grant was received by Abbott Italy, to cover the costs for the reprocessing of data. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Cost-Utility Analysis of Lopinavir/Ritonavir versus Atazanavir + Ritonavir Administered as First-Line Therapy for the Treatment of HIV Infection in Italy: From Randomised Trial to Real World

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Abstract

Objective

Design

Methodology

Results

Conclusions

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PLOS: COVID-19 pandemic

Most cited references 13

Modelling in economic evaluation: an unavoidable fact of life.

Health-related quality of life and health care costs in severe, refractory irritable bowel syndrome.

Impact of irritable bowel syndrome on quality of life.

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