LONG-TERM HEALTH BENEFIT OF IBALIZUMAB IN THE TREATMENT OF ADULTS WITH MULTIDRUG-RESISTANT HIV-1 INFECTION
Author(s)
Brogan AJ1, Talbird SE2, Davis AE2, La EM2, Miao Z3, Lewis S4
1RTI Health Solutions, Didsbury, Manchester, NC, UK, 2RTI Health Solutions, Research Triangle Park, NC, USA, 3Theratechnologies Inc., Montréal, QC, Canada, 4TaiMed Biologics, Irvine, CA, USA
OBJECTIVES: Individuals with multidrug-resistant (MDR) HIV-1 infection represent a difficult-to-treat population with limited remaining antiretroviral options and substantial associated morbidity and mortality. Ibalizumab is a first-in-class, long-acting, post-attachment HIV-1 inhibitor administered by infusion every 2 weeks for adults with MDR HIV-1 infection. This analysis examines the long-term health benefit of ibalizumab treatment for this population. METHODS: A Markov model was developed to follow a cohort of adults with MDR HIV-1 infection over their remaining lifetimes as they progressed through two final lines of antiretroviral therapy, receiving either ibalizumab + optimized background therapy (OBT) or OBT alone prior to salvage therapy. Over time, individuals could respond (HIV RNA < 50 copies/mL at week 25), transition between health states based on CD4 cell count, and experience treatment failure or death from HIV-related or non–HIV-related causes. Upon treatment failure (defined for responders as protocol-defined virologic failure and for partial/non-responders as two consecutive visits with HIV RNA ≥ 200 copies/mL), individuals discontinued ibalizumab and switched to salvage therapy. Treatment efficacy was based on preliminary phase 3 (ibalizumab+OBT) and adjusted phase 2a (OBT alone) clinical trial data, and published literature estimates were used to parameterize other model inputs. Average per-person outcomes were discounted at 3% per year. RESULTS: Compared with individuals receiving OBT alone, the model showed that individuals treated with ibalizumab+OBT experienced 0.77 more life years (9% improvement) and had a 7% reduction in HIV-related deaths. Individuals receiving ibalizumab also spent 0.28 more years on initial therapy (65% improvement) and 0.95 more years with CD4 cell counts above 200 cells/µL (28% improvement). Results were robust in sensitivity analysis. CONCLUSIONS: Ibalizumab treatment is predicted to provide substantial health and life-expectancy benefits for adults with MDR HIV-1 infection. For this population with limited remaining antiretroviral options, ibalizumab could represent an important step toward improved outcomes.
Conference/Value in Health Info
2018-05, ISPOR 2018, Baltimore, MD, USA
Value in Health, Vol. 21, S1 (May 2018)
Code
IN2
Topic
Clinical Outcomes
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
Infectious Disease (non-vaccine), Rare and Orphan Diseases