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      • Daclatasvir and Asunaprevir Combination Therapy for Chronic Hepatitis C Virus Genotype 1b Infection in Real World

        ( Min Keun Kim ),( Sangah Baek ),( Ga Young Kim ),( Hyeon Chul Lee ),( Hyesun Lee ),( Eun Jeong Kim ),( Chang Hyeong Lee ),( Byung Seok Kim ) 대한간학회 2016 춘·추계 학술대회 (KASL) Vol.2016 No.1

        Aims: Recently, treatment of hepatitis C virus (HCV) has evolved and improved remarkably. Use of all-oral combination regimens of direct- acting antivirals (DAAs) in chronic hepatitis C (CHC) patients shows a sustained virologic response (SVR) rate of ≥90%. Daclatasvir (DCV) plus asunaprevir (ASV) combination therapy has produced high rates of SVR among HCV genotype 1b patients without baseline NS5A resistance-associated variants (RAVs) in clinical trials. We evaluated the efficacy and safety of DCV and ASV combination therapy for chronic HCV genotype 1b infection in real world. Methods: We retrospectively reviewed the medical records of patients with chronic HCV genotype 1b infection. A total of 86 patients (57 treatment-naive patients), who were treated with DCV and ASV combination at their recommended doses, were enrolled in this study. We evaluated the virologic response rates at week 4, 12, 24 of treatment, and week 12 after completion of treatment (SVR12). Results: The mean age was 58.52±9.78 years, and 41 patients (47.7%) were men. Thirty patients (34.9%) had cirrhosis. Baseline NS5A sequences were available from 80 patients. Pretreatment NS5A RAVs were present in 4 patients (5.0%). DCV plus ASV provided virologic response in 73 patients (100%) at week 4; 55 patients (96.5%) at week 12; 18 patients (94.7%) at week 24 of treatment; one patient (100%) at week 12 after completion of treatment. Adverse events occurred in 6 patients. Adverse events included headache, nausea, diarrhea, and skin rash. No serious adverse events occurred. Conclusions: DCV and ASV combination therapy provided high rates of virologic response at week 4, 12, 24 of treatment, and week 12 after completion of treatment in chronic HCV genotype 1b infection patients in real world. DCV plus ASV was well tolerated without serious adverse events. We also expect high SVR rate after DCV plus ASV treatment in a large number of cases.

      • Prolonged Tenofovir Monotherapy for Partial Virologic Response to Tenofovir in Treatment-naive Chronic Hepatitis B Patients

        ( Min Keun Kim ),( Sangah Baek ),( Ga Young Kim ),( Hyeon Chul Lee ),( Hyesun Lee ),( Eun Jeong Kim ),( Chang Hyeong Lee ),( Byung Seok Kim ) 대한간학회 2016 춘·추계 학술대회 (KASL) Vol.2016 No.1

        Aims: Tenofovir disoproxil fumarate (TDF) has highly potent antiviral activity with a high genetic barrier to resistance in chronic hepatitis B (CHB) patients. The optimal management of CHB patients exhibiting a partial virologic response (PVR) to TDF is currently not established. The aim of this study was to evaluate the long-term efficacy of prolonged TDF monotherapy in treatment-naive CHB patients exhibiting a PVR to TDF therapy. Methods: This retrospective study included 139 treatment-naive CHB patients treated with TDF for ≥48 weeks and who received continuous TDF monotherapy for ≥24 weeks at Daegu Catholic University Hospital. PVR was defined as a decrease in serum HBV DNA of more than 2 log10 IU/mL from baseline but detectable HBV DNA by real- time PCR assay at week 48. All patients were monitored at baseline and every 3 months during treatment. Results: Thirty of 139 patients (21.6%) showed PVR. The mean follow- up duration in PVR group was 90.0±17.7 weeks. The mean age was 48.4±13.9 years, and 20 patients (66.7%) were men. Twenty-two patients (73.3%) were HBeAg-positive, and 13 patients (43.3%) had cirrhosis. Fifteen of 30 patients (50.0%) achieved a virologic response (VR, HBV DNA <20 IU/ml) during prolonged TDF monotherapy for ≥24 weeks. VR rate in HBeAg-positive patients was 50.0% (11/22). Among 15 patients who did not achieve a VR during continuous TDF therapy, 10 patients had poor drug compliance. The overall cumulative rates of VR at week 60, 72, 84, and 96 from treatment initiation in patients with PVR were 25.0%, 41.4%, 47.1%, and 53.3%, respectively. The PVR was associated with HBV DNA levels at baseline, week 4, 12, and 24, and also with virologic breakthrough. Conclusions: Long-term continuous TDF monotherapy with good medication compliance may be effective for achieving VR in treatment- naive CHB patients exhibiting a PVR to TDF therapy.

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