982 Cost-Effectiveness of First-Line Versus Second-Line Telaprevir Combination Treatment in the Management of Chronic Hepatitis C Virus Infection for Treatment-NaïVE Patients With IL28B Genotype CC

Purpose: Telaprevir (T) in combination with peginterferon alfa-2a/ribavirin (PR) substantially increased sustained virologic response (SVR) compared with PR alone in the phase 3 studies ADVANCE (treatment-naive patients) and REALIZE (previously treated patients) in patients with genotype 1 chronic hepatitis C virus (HCV) infection and IL28B genotype CC, a subgroup more likely to achieve SVR on PR or T/PR. A decision-analytic model was developed to estimate the long-term clinical and economic outcomes of treatment with response-guided 12-week T with 24or 48-week PR (T12PR24/48) or a hypothetical T12PR12 regimen, compared with a two-step approach (first-line PR48 followed by second-line T12PR48, if necessary) for treatment-naive patients with IL28B genotype CC in the United States (US). Methods: A lifetime two-phase (treatment; post-treatment) decision-analytic model was developed to follow parallel hypothetical cohorts treated with T/PR or PR alone. Patients first entered the 72-week decision-tree treatment phase of the model; those who did not achieve SVR on first-line PR therapy were eligible for second-line T/PR. After treatment completion, patients entered the cyclic Markov post-treatment phase. In any 1-year cycle, patients could remain in or transition among the following health states: four pre-cirrhosis health states, compensated cirrhosis, decompensated cirrhosis, hepatocellular carcinoma, liver transplantation, and death. Clinical data were obtained from the IL28B CC subgroups in ADVANCE and REALIZE when data were available (SVR rates) and from the overall trial populations otherwise. Health state transition probabilities (which varied by SVR status, age, and gender), costs, utilities, andmortality were obtained from the clinical trials, published sources, or assumption. The perspective of the analysis was that of a third-party US payer. Sensitivity analyses were performed. Results: The model projected that over the remaining lifetime of patients, the first-line T/PR regimens yielded higher effective SVR rates and more quality-adjusted life-years (QALYs) than a two-step treatment approach in which 50% of eligible patients who failed first-line PR were re-treated with second-line T/PR. Incremental cost-effectiveness ratios (ICERs) were estimated at $25,517 and $24,429 per QALY gained for the standard T12PR24/48 regimen and the hypothetical T12PR12 regimen, respectively. In sensitivity analysis assuming 75% re-treatment, the ICERs were $30,766 and $32,300 per QALY gained, respectively (Table 1). Conclusions: Model projections suggest that in treatment-naive patients with IL28B genotype CC, first-line telaprevir combination treatment may be relatively effective and cost-effective according to traditional thresholds when compared with a two-step approach of first-line PR followed by second-line T/PR.