Abstract
Background: Persons with HIV and tuberculosis (TB) co-infection require transaminase monitoring while on hepatotoxic medications. A novel paper-based, point-of-care transaminase test is in development at an anticipated cost of $1 per test. Methods: To project long-term clinical outcomes and estimate the cost-effectiveness of using a paper-based fingerstick test to monitor for drug-induced liver injury (DILI), as compared with automated testing and with no laboratory monitoring. The design was a decision analytic model, including deterministic and probabilistic sensitivity analyses. Data sources were observational cohorts and a validation study of the paper-based test. The target population was HIV/TB co-infected persons in South Africa on antiretroviral therapy who were initiating TB therapy. Interventions: (1) clinical (no laboratory) monitoring; (2) monitoring using the paper-based test with a ≥120 IU/mL threshold for positivity; (3) monitoring using the paper-based test with a ≥200 IU/mL threshold for positivity; (4) monitoring using the paper-based test using 1 of 3 categories: <120 IU/mL, 120 to 200 IU/mL, and >200 IU/mL ("bin placement"); (5) monitoring using automated ALT testing using the same 3 categories ("automated testing"). The outcome measures were discounted quality-adjusted life-years (QALYs), costs, and incremental cost-effectiveness ratios (ICERs). Results: The ICER of automated testing was $5180/QALY. Use of the paper-based test with the bin placement strategy was cost-effective compared with clinical monitoring alone. Conclusion: At its current performance, monthly DILI monitoring by bin placement using the paper-based test was cost-effective, compared with clinical monitoring, in HIV/TB co-infected persons in South Africa.
Original language | English (US) |
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Article number | ofx194 |
Journal | Open Forum Infectious Diseases |
Volume | 4 |
Issue number | 4 |
DOIs | |
State | Published - 2017 |
Bibliographical note
Funding Information:Research reported in this publication was supported by the Harvard University Center for AIDS Research (CFAR; P30 AI060354), The Brown-Tufts-BUMC CFAR (P30 AI042853), The Center for Health Economics of Treatment Interventions for Substance Use Disorder, HCV, and HIV (P30DA040500), the National Institute on Drug Abuse (R01 DA031059), and the National Center for Advancing Translational Sciences of the National Institutes of Health (UL1TR000114). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Publisher Copyright:
© 2017 The Author.
Keywords
- drug-induced liver injury
- lab monitoring
- point-of-care diagnostics
- tuberculosis