Strategic International Session3 (JSH)
October 27, 9:00–12:00, Room 9 (Fukuoka International Congress Center 413+414)
ST3-5_H

Clinical Management of HCV - Special Populations and Remaining Issues

Masayuki Kurosaki
Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital
Although a high rate of SVR could be expected by pan-genotypic DAA, an individualized treatment strategy is needed in retreatment for patients with prior DAA treatment failure. A central measurement system for resistance-associated substitutions (RAS) on a nationwide scale was built to facilitate the selection of an optimal re-treatment regimen. In this nationwide study, patients who failed prior DAA and were re-treated with GLE/PIB for 12 weeks (n=1,211) or SOF/VEL+RBV for 24 weeks (n=173) were evaluated. The overall SVR rate was 98% in GLE/PIB and 97% in SOF/VEL+RBV. Among genotype 1b patients with the P32del RAS in NS5A, the SVR rate was 10% in GLE/PIB and 97% in SOF/VEL+RBV. Other than P32del, Q24K+L28M/V+R30H and Q24K+L28M+A92K attenuated the SVR rate in GLE/PIB (<90%) but not in SOF/VEL+RBV (100%). Therefore, SOF/VEL+RBV may be effective for GLE/PIB-resistant RAS. These results confirmed the importance of RAS assessment in patients with prior DAA treatment failure for the selection of an optimal re-treatment regimen.
Another important issue is the selection of patients who need continuous surveillance for HCC after SVR. By the nationwide Japanese Red Cross hospital cohort of patients who achieved SVR by DAAs, factors associated with HCC development were analyzed. Liver stiffness greater than 3.75 KPa by MR elastography after SVR or serum M2BPGi greater than 1.85 COI at SVR or at 1 year after SVR was a significant predictor of HCC development. Apart from these special tests, a readily available predictor of HCC development was investigated. FIB-4 index greater than 3.25 at any time point after SVR was associated with a high incidence of HCC development. By using data 1 year after SVR, simple criteria called GAF4 criteria were developed to narrow down patients at low risk of HCC development. Low-risk patients were defined as having gamma-glutamyl transferase < 28 IU/L, alpha-fetoprotein < 4.0 ng/mL, albumin>4.1, and FIB-4 index < 2.86. Their risk of HCC development was 0.5-1.1 per 100 person-years. From these results, not only the stage of fibrosis at baseline but also the non-invasive assessment of factors after SVR should be utilized to define patients who should continue surveillance for HCC after SVR.
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