Lars Oddershede1,2, Simon Walker3, Wolfgang Stöhr4, David T Dunn4, Alejandro Arenas-Pinto4, Nicholas I Paton4,5, Mark Sculpher6. 1. The Danish Center for Healthcare Improvements, Faculty of Social Sciences and Faculty of Health Sciences, Aalborg University, Aalborg, Denmark. 2. HEOR Consult ApS, Copenhagen, Denmark. 3. Centre for Health Economics, The University of York, York, YO10 5DD, UK. smw501@york.ac.uk. 4. MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, London, UK. 5. Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore. 6. Centre for Health Economics, The University of York, York, YO10 5DD, UK.
Abstract
BACKGROUND:Protease inhibitor (PI) monotherapy can maintain virological suppression in the majority of patients once it has been established on triple therapy and may also have the potential for substantial cost savings arising from the use of fewer drugs. However, the cost effectiveness of PI monotherapy has yet to be demonstrated. OBJECTIVES: In this study we examine the cost effectiveness of PI monotherapy with prompt return to combination therapy in the event of viral load rebound compared with ongoing triple therapy (OT) in patients with suppressed viral load on combination antiretroviral therapy (ART) in the UK. METHODS: The analysis used data from the PIVOT trial in which HIV-positive adults with suppressed viral load for ≥24 weeks on combination ART were randomised to maintain OT or to a strategy of PI monotherapy with prompt return to combination therapy if viral load rebounded. A cost-effectiveness analysis including long-term modelling was conducted. Main outcomes included UK National Health Service (NHS) costs and quality-adjusted life-years (QALYs) with comparative results presented as incremental cost-effectiveness ratios. RESULTS:PI monotherapy was cost saving as a result of large savings in ART drug costs while being no less effective in terms of QALYs in the within-trial analysis and marginally less effective with lifetime modelling. In the base-case analysis over 3 years, the incremental total cost per patient was -£6424.11 (95 % confidence interval -7418.84 to -5429.38) and incremental QALYs were 0.0051 (95 % CI -0.0479 to 0.0582), resulting in PI monotherapy 'dominating' OT. Multiple scenario analyses found that PI monotherapy was cost saving with no marked differences in QALYs. Modelling of lifetime costs and QALYs showed that PI monotherapy was associated with significant cost savings and was marginally less effective; PI monotherapy was cost effective at accepted cost-effectiveness thresholds in all but one scenario analysis. CONCLUSIONS: Under most assumptions, PI monotherapy appears to be a cost-effective treatment strategy compared with OT for HIV-infected patients who have achieved sustained virological suppression.
RCT Entities:
BACKGROUND:Protease inhibitor (PI) monotherapy can maintain virological suppression in the majority of patients once it has been established on triple therapy and may also have the potential for substantial cost savings arising from the use of fewer drugs. However, the cost effectiveness of PI monotherapy has yet to be demonstrated. OBJECTIVES: In this study we examine the cost effectiveness of PI monotherapy with prompt return to combination therapy in the event of viral load rebound compared with ongoing triple therapy (OT) in patients with suppressed viral load on combination antiretroviral therapy (ART) in the UK. METHODS: The analysis used data from the PIVOT trial in which HIV-positive adults with suppressed viral load for ≥24 weeks on combination ART were randomised to maintain OT or to a strategy of PI monotherapy with prompt return to combination therapy if viral load rebounded. A cost-effectiveness analysis including long-term modelling was conducted. Main outcomes included UK National Health Service (NHS) costs and quality-adjusted life-years (QALYs) with comparative results presented as incremental cost-effectiveness ratios. RESULTS: PI monotherapy was cost saving as a result of large savings in ART drug costs while being no less effective in terms of QALYs in the within-trial analysis and marginally less effective with lifetime modelling. In the base-case analysis over 3 years, the incremental total cost per patient was -£6424.11 (95 % confidence interval -7418.84 to -5429.38) and incremental QALYs were 0.0051 (95 % CI -0.0479 to 0.0582), resulting in PI monotherapy 'dominating' OT. Multiple scenario analyses found that PI monotherapy was cost saving with no marked differences in QALYs. Modelling of lifetime costs and QALYs showed that PI monotherapy was associated with significant cost savings and was marginally less effective; PI monotherapy was cost effective at accepted cost-effectiveness thresholds in all but one scenario analysis. CONCLUSIONS: Under most assumptions, PI monotherapy appears to be a cost-effective treatment strategy compared with OT for HIV-infectedpatients who have achieved sustained virological suppression.
Authors: Jens D Lundgren; Abdel G Babiker; Fred Gordin; Sean Emery; Birgit Grund; Shweta Sharma; Anchalee Avihingsanon; David A Cooper; Gerd Fätkenheuer; Josep M Llibre; Jean-Michel Molina; Paula Munderi; Mauro Schechter; Robin Wood; Karin L Klingman; Simon Collins; H Clifford Lane; Andrew N Phillips; James D Neaton Journal: N Engl J Med Date: 2015-07-20 Impact factor: 91.245
Authors: Karl Claxton; Steve Martin; Marta Soares; Nigel Rice; Eldon Spackman; Sebastian Hinde; Nancy Devlin; Peter C Smith; Mark Sculpher Journal: Health Technol Assess Date: 2015-02 Impact factor: 4.014
Authors: Margaret May; Mark Gompels; Valerie Delpech; Kholoud Porter; Frank Post; Margaret Johnson; David Dunn; Adrian Palfreeman; Richard Gilson; Brian Gazzard; Teresa Hill; John Walsh; Martin Fisher; Chloe Orkin; Jonathan Ainsworth; Loveleen Bansi; Andrew Phillips; Clifford Leen; Mark Nelson; Jane Anderson; Caroline Sabin Journal: BMJ Date: 2011-10-11
Authors: Nicholas I Paton; Wolfgang Stöhr; Alejandro Arenas-Pinto; Martin Fisher; Ian Williams; Margaret Johnson; Chloe Orkin; Fabian Chen; Vincent Lee; Alan Winston; Mark Gompels; Julie Fox; Karen Scott; David T Dunn Journal: Lancet HIV Date: 2015-09-14 Impact factor: 12.767
Authors: Ian Williams; Duncan Churchill; Jane Anderson; Marta Boffito; Mark Bower; Gus Cairns; Kate Cwynarski; Simon Edwards; Sarah Fidler; Martin Fisher; Andrew Freedman; Anna Maria Geretti; Yvonne Gilleece; Rob Horne; Margaret Johnson; Saye Khoo; Clifford Leen; Neal Marshall; Mark Nelson; Chloe Orkin; Nicholas Paton; Andrew Phillips; Frank Post; Anton Pozniak; Caroline Sabin; Roy Trevelion; Andrew Ustianowski; John Walsh; Laura Waters; Edmund Wilkins; Alan Winston; Mike Youle Journal: HIV Med Date: 2012-09 Impact factor: 3.180
Authors: Margaret T May; Mark Gompels; Valerie Delpech; Kholoud Porter; Chloe Orkin; Stephen Kegg; Phillip Hay; Margaret Johnson; Adrian Palfreeman; Richard Gilson; David Chadwick; Fabiola Martin; Teresa Hill; John Walsh; Frank Post; Martin Fisher; Jonathan Ainsworth; Sophie Jose; Clifford Leen; Mark Nelson; Jane Anderson; Caroline Sabin Journal: AIDS Date: 2014-05-15 Impact factor: 4.177
Authors: Alicia Gutierrez-Valencia; Maria Trujillo-Rodriguez; Tamara Fernandez-Magdaleno; Nuria Espinosa; Pompeyo Viciana; Luis F López-Cortés Journal: J Int AIDS Soc Date: 2018-02 Impact factor: 5.396
Authors: Cassidy W Claassen; David Keckich; Chidi Nwizu; Alash'le Abimiku; Donald Salami; Michael Obiefune; Bruce L Gilliam; Anthony Amoroso Journal: J Int Assoc Provid AIDS Care Date: 2019 Jan-Dec