Universal Journal of Medical Science Vol. 4(1), pp. 10 - 20
DOI: 10.13189/ujmsj.2016.040102
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Five Laboratory Tests Predict Patient Risk and Treatment Response in Hepatitis C: Veterans Affairs Data from 1999-2010

Ivy Tonnu-Mihara 1, Tara Matsuda 1,2, Jeff McCombs 2,*, Sammy Saab 3, Patricia Hines 4, Gilbert L’Italien 4,5, Timothy Juday 4,6, Yong Yuan 4
1 Veterans Affairs Long Beach Healthcare System, U.S. Department of Veterans Affairs, USA
2 Department of Pharmaceutical and Health Economics, School of Pharmacy, Leonard Schaeffer Center for Health Policy and Economics, University of Southern California, USA
3 Department of Medicine and Surgery, David Geffen School of Medicine, University of California-Los Angeles, USA
4 Global Health Economics and Outcomes Research, Bristol-Myers Squibb, USA
5 Biogen Idec in Boston, USA
6 Abbvie Pharmaceuticals in Abbott Park, Il, USA


Background and Aims: New Hepatitis C [HCV] drugs are expensive but highly effective but have created an overwhelming ‘cash flow' problem for payers facing a large bolus of infected patients. Health plans are developing ‘watchful waiting' strategies to safely defer treatment for low risk patients. This study identifies five laboratory tests which predict increasing risk of liver related events and documents that delaying treatment until after an abnormal lab test diminished effectiveness of treatment with interferon alpha plus ribavirin. Methods: Patients from the Veterans Administration's clinical registry of HCV patients [1999-2010] were screened for a detectable viral load at baseline and a recorded baseline genotype. The primary outcomes were time to death and time to time to a composite clinical event. Cox proportional hazards models were estimated with time dependent independent variables for initial treatment and first abnormal laboratory test. Results: 128,769 patients met all inclusion criteria. Abnormal values for five laboratory were associated with increased risk for the composite outcome/death: 1.35/1.84 for the AST/ALT ratio > 1; 2.35/5.01 for albumin < 3 g/Dl; 1.58/1.15 for GGT > 195 IU/L; 3.85/1.55 for platelet count < 100 k/mm2 and 4.48/2.39 for alpha fetoprotein > 144 ng/mL. Delaying drug therapy until after an abnormal lab test significantly reduced treatment effectiveness. Discussion: Five tests predict liver complications for HCV patients which can be used to develop "watchful waiting" protocols which monitor untreated HCV patients over time and defer access to expensive new drug regimens to those patients most at risk adverse liver-related events.

Watchful Waiting, Abnormal Lab Test, Risk Predictors, Delayed Treatment

Cite this paper
Ivy Tonnu-Mihara , Tara Matsuda , Jeff McCombs , Sammy Saab , Patricia Hines , Gilbert L’Italien , Timothy Juday , Yong Yuan . "Five Laboratory Tests Predict Patient Risk and Treatment Response in Hepatitis C: Veterans Affairs Data from 1999-2010." Universal Journal of Medical Science 4.1 (2016) 10 - 20. doi: 10.13189/ujmsj.2016.040102.