Session Title: Category 5g. VIRAL HEPATITIS: g. HEPATITIS C - CLINICAL (THERAPY)
Presentation Date: Apr 15, 2010
HEPATITIS C TREATMENT IN PATIENTS WITH GENOTYPE 2/3: 16 VS. 24 WEEKS; ANALYSIS OF OUTCOME, HRQOL, DIRECT AND INDIRECT COSTS
T. Dal Bianco1*, A. Grasso2, A. Carlotto3, F. Malfatti2, A.M. Miotti4, M.T. Giordani4, A. Tramarin4, P. Fabris4
1Dept. of Medicine, Hospital of Monfalcone, Monfalcone, 2Dept. of Medicine, Hospital of Savona, Savona, 3Dept. of Infectious Diseases, Hospital of Schio, Schio, 4Infectious Diseases and Tropical Medicine, S. Bortolo Hospital, Vicenza, Italy. *firstname.lastname@example.org
Background and aims: It has been reported that 16 and 24 weeks treatment with PEG-IFN and RBV are comparable, in term of outcome, in hepatitis C patients genotype 2 or 3. Differences concerning quality of life and costs between short and standard therapy have not been deeply investigated so far.
Methods: We enrolled 101 patients in a randomized study with administration of Peg-IFN alfa 2b plus ribavirin according to the body weight. Patients HCV-RNA negative or with a decay of VL>2 log from baseline to week 4 were randomised to receive overall 16 or 24 weeks of therapy. At baseline, clinical parameters (demographic, laboratory, histological anthropometric data) were collected. Patients with cirrhosis were treated with standard protocol. Moreover, at 0, 12 and 24 weeks, health related quality of life (HRQoL) was assessed by the Chronic Liver Disease Questionnaire Italian Version (CDLQ-I). Direct costs were estimated by acquisition drugs, laboratory and visits costs, according to National Tariffs System (€). Indirect costs were also estimated by the Health and Labour Questionnaire (HLQ) at the same time points.
Results: Up to now, 86 patients (genotype 2 N.45, and 3 N.41) completed the treatment and the 6 months follow up. The overall response was SVR 75.6%. Among the 74 randomized patients, SVR was achieved in 63 (85.1%); without significant difference between 16 and 24 weeks arm (30; 83.3% and 33; 86.9%, respectively, p=ns). Mean per patient treated cost (including drugs/test/consultations) in the 16 weeks arm was significantly lower than that one of 24 weeks arm (4801 € vs 7039 €, respectively). At 6 months evaluation, patients treated for 16 weeks reported a statistically significant improvement with respect to patients treated for 24 weeks, in fatigue (76% vs 21%), activity (72% vs 18%) emotional function (27% vs 5%). Indirect costs were estimated as 5% lower in short arm.
Conclusions: Using this approach for each SVR obtained with short therapy we save more than 32% of costs. Our study demonstrates that 16 weeks of treatment in patients who achieved a virological response after 4 weeks is better tolerated and cost-effective.