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US Cost Effectiveness of Darunavir/Ritonavir 600/100mg bid in Treatment-Experienced, HIV-Infected Adults with Evidence of Protease Inhibitor Resistance Included in the TITAN Trial

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Abstract

Introduction: The phase III TITAN trial evaluated the use of darunavir with low-dose ritonavir (DRV/r) 600/100mg twice daily (bid) compared with lopinavir with low-dose ritonavir (LPV/r) in treatment-experienced, lopinavirnaive patients. This study estimates the cost effectiveness of DRV/r from a US societal perspective when compared with LPV/r in treatment-experienced patients with a profile similar to those TITAN patients who had one or more International AIDS Society — USA (IASUSA) primary protease inhibitor (PI) resistance-associated mutations (RAMs) at baseline. This population had less advanced HIV disease and a broader range of previous PI exposure/failure (0–≥2 PIs) at enrolment than those in the darunavir phase IIb POWER trials.

Methods: An existing Markov model containing six health states defined by CD4 cell count range (>500, 351–500, 201–350, 101–200, 51–100 and 0–50 cells/mm3) and an absorbing state of death was adapted. Baseline demographics, CD4 cell count distribution and antiretroviral drug usage, virological response (at week 24), and immunological response estimates and matching transition probabilities were based on data collected directly from the one or more IASUSA PI mutation subpopulation during the first 48 weeks of the TITAN trial, as well as from published literature. Patients were assumed to switch to a regimen containing tipranavir plus an optimized background regimen after treatment failure. For each CD4 cell count range or health state, the utility values, HIV and non-HIV-related mortality rates, and non-antiretroviral-related cost of HIV care estimates were derived from published literature. Unit costs were derived from official local sources. A lifetime horizon was taken in the base-case analysis.

Results: The base-case analysis predicted discounted quality-adjusted survival gains of 0.493 quality-adjusted life-years (QALYs) for DRV/r compared with LPV/r, resulting in an incremental cost-effectiveness ratio (ICER) of US$23 057 per QALY gained over a lifetime horizon. Probabilistic sensitivity analysis indicated a 0.754 probability of an ICER below the threshold of US$50 000 per QALY gained. DRV/r remained cost effective over all parameter ranges tested in extensive one-way sensitivity analyses and variability analyses, which examined the impact of input parameter uncertainty and changes in model assumptions and treatment patterns, respectively. Shortening the model time horizon had the largest impact on the ICER, reducing it most notably to US$4919 with a 10-year time horizon.

Conclusion: From a US societal perspective and based on an analysis of the patients with primary IASUSA PI RAMs enrolled in the darunavir phase III TITAN trial, a highly active antiretroviral therapy (HAART) regimen containingDRV/r 600/100mg bid is estimated to be a cost-effective therapy when compared with a HAART regimen containing LPV/r, for the management of treatment-experienced, PI-resistant, HIV-infected adults with a broad range of previous PI use/failure.

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Acknowledgements

The authors are grateful to Tony Vangeneugden, Ben Van Baelen, Els De Paepe, Eric Lefebvre, Sabrina Spinosa-Guzman, Frank Tomaka, Piet De Doncker and the rest of the darunavir study team at Tibotec Pharmaceuticals, Mechelen, Belgium, for their contributions in analysing and generating the TITAN-specific efficacy data included in this analysis. The authors also acknowledge Catherine Elliott (medical writer, Gardiner-Caldwell Communications, Macclesfield, UK) for her editorial support. Finally, they thank the study investigators, the patients and their families for their participation and support during the TITAN trial. This project was supported financially by Johnson & Johnson Pharmaceutical Services.

AB, JM and SET, employees of RTI Health Solutions, have received grant support from Janssen-Cilag, the manufacturer of darunavir, to assist with the preparation of the manuscript. They were not restricted by Janssen-Cilag in their analysis or in their interpretation of the final results. ES is an employee of Johnson & Johnson Pharmaceutical Services, Beerse, Belgium, and owns stock options and shares in this company.

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Brogan, A., Mauskopf, J., Talbird, S.E. et al. US Cost Effectiveness of Darunavir/Ritonavir 600/100mg bid in Treatment-Experienced, HIV-Infected Adults with Evidence of Protease Inhibitor Resistance Included in the TITAN Trial. Pharmacoeconomics 28 (Suppl 1), 129–146 (2010). https://doi.org/10.2165/11587490-000000000-00000

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