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( Vijay Gayam ),( Muhammad Rajib Hossain ),( Mazin Khalid ),( Sandipan Chakaraborty ),( Osama Mukhtar ),( Sumit Dahal ),( Amrendra Kumar Mandal ),( Arshpal Gill ),( Pavani Garlapati ),( Sreedevi Ramak 대한소화기학회 2018 Gut and Liver Vol.12 No.6
Background/Aims: Limited data exist comparing the safety and efficacy of direct-acting antivirals (DAAs) in hepatitis C virus (HCV) monoinfected and HCV/human immunodeficiency virus (HIV) coinfected patients in the real-world clinic practice setting. Methods: All HCV monoinfected and HCV/HIV coinfected patients treated with DAAs between January 2014 and October 2017 in community clinic settings were retrospectively analyzed. Pretreatment baseline patient characteristics, treatment efficacy, factors affecting sustained virologic response at 12 weeks (SVR12) after treatment, and adverse reactions were compared between the groups. Results: A total of 327 patients were included in the study, of which 253 were HCV monoinfected, and 74 were HCV/HIV coinfected. There was a statistically significant difference observed in SVR12 when comparing HCV monoinfection and HCV/HIV coinfection (94% and 84%, respectively, p=0.005). However, there were no significant factors identified as a predictor of a reduced response. The most common adverse effect was fatigue (27%). No significant drug interaction was observed between DAA and antiretroviral therapy. None of the patients discontinued the treatment due to adverse events. Conclusions: In a real-world setting, DAA regimens have lower SVR12 in HCV/HIV coinfection than in HCV monoinfection. Further studies involving a higher number of HCV/HIV coinfected patients are needed to identify real predictors of a reduced response. (Gut Liver 2018;12:694-703)
Soon Kyu Lee,Sung Won Lee,Hae Lim Lee,Hee Yeon Kim,Chang Wook Kim,Do Seon Song,U Im Chang,Jin Mo Yang,Sun Hong Yoo,Jung Hyun Kwon,Soon Woo Nam,Seok-Hwan Kim,Myeong Jun Song,Jaejun Lee,Hyun Yang,Si Hyu 대한내과학회 2022 The Korean Journal of Internal Medicine Vol.37 No.6
Background/Aims : To evaluate the efficacy and safety of ledipasvir/sofosbuvir (LDV/SOF) therapy in hepatitis C virus (HCV)-infected Korean patients in a real clinical setting. Methods: A total of 273 patients who received LDV/SOF therapy between May 2016 and February 2021 were consecutively enrolled and analyzed. A per-protocol analysis was performed to evaluate the virologic response. Results: Seventy-five percent were infected with genotype 1, and 25% were infected with genotype 2. A hundred eightyone (66.3%) patients had chronic hepatitis, 74 (27.1%) had compensated cirrhosis, eight (2.9%) had decompensated cirrhosis, and 10 (3.7%) had undergone liver transplantation. Undetectable HCV RNA at week 4 was achieved in 90.2% (231/256) of patients, 99.2% (250/252) achieved the end of treatment response, and 98.1% (202/206) achieved sustained virologic response at 12 weeks post-treatment (SVR12). According to liver function, the SVR12 rates were 99.3% (135/136) in chronic hepatitis, 96.4% (53/55) in compensated cirrhosis, and 100% (6/6) in decompensated cirrhosis. The SVR12 rates according to the genotype were 98.2% (167/170) for genotype 1 and 97.2% (35/36) for genotype 2. An 8-week LDV/SOF treatment in treatment-naïve chronic hepatitis patients with HCV RNA < 6,000,000 IU/mL at baseline resulted in 100% (23/23) SVR12 rates. Overall, LDV/SOF was tolerated well, with a 0.7% (2/273) discontinuation rate due to adverse events that were unrelated to LDV/SOF. Conclusions: LDV/SOF is effective and safe for treating HCV-infected Korean patients with high SVR12 rates.
( Qing-lei Zeng ),( Bing Li ),( Xue-xiu Zhang ),( Yan Chen ),( Yan-ling Fu ),( Jun Lv ),( Yan-min Liu ),( Zu-jiang Yu ) 대한소화기학회 2016 Gut and Liver Vol.10 No.6
Background/Aims: No clinical model exists to predict the occurrence of hepatocellular carcinoma in sustained virologic response-achieving (HCC after SVR) patients with chronic hepatitis C (CHC). Methods: We performed a case-control study using a clinical database to research the risk factors for HCC after SVR. A predictive model based on risk factors was established, and the area under the receiver operating characteristic curve (AUC) was calculated. Results: In the multivariate model, an initial diagnosis of compensated cirrhosis and post-SVR albumin reductions of 1 g/L were associated with 21.7-fold (95% CI, 4.2 to 112.3; p< 0.001) and 1.3-fold (95% CI, 1.1 to 1.7; p=0.004) increases in the risk of HCC after SVR, respectively. A predictive model based on an initial diagnosis of compensated cirrhosis (yes, +1; no, 0) and post- SVR albumin ≤36.0 g/L (yes, +1; not, 0) predicted the occurrence of HCC after SVR with a cutoff value of >0, an AUC of 0.880, a sensitivity of 0.833, a specificity of 0.896, and a negative predictive value of 0.956. Conclusions: An initial diagnosis of compensated cirrhosis combined with a post-SVR albumin value of ≤36.0 g/L predicts the occurrence of HCC after SVR in patients with CHC. (Gut Liver 2016;10:955-961)
( Hyunhwa Yoon ),( Young Kul Jung ),( Seung Jun Jang ),( Seung Kak Shin ),( Hae Lim Baek ),( Soo Yong Park ),( Min Young Rim ),( Hyeonsu Park ),( In Ku Yo ),( Oh Sang Kwon ),( Yun Soo Kim ),( Duck Joo 대한간학회 2013 춘·추계 학술대회 (KASL) Vol.2013 No.1
Background: The combination theraphy with peginterferon and ribavirin has been used to treat chronic hepatitis C for several years in Korea, yet there is a few reports regarding the results of the genotype 2, 3. We evaluated factors influencing SVR in Korean patients with genotype 2 and 3 chronic hepatitis C after combination theraphy conducted at a single center. Methods: This study was performed to investigate the factors that affect sustained virologic response (SVR) who underwent combination theraphy consist of peginterferon and ribavirin. Reptrosepctively, a total of 98 patients untreated genotype 2 and 3 chronic hepatitis C were enrolled and completed the treatment (52 males(53.06%), genotype 2: 96 (97.96%)). Duration of the treatment was 16-24 weeks. Response of the treatment was evaluated by rapid virologic response (RVR), end treatment virologic response (ETR) and sustained virologic response (SVR). Results: The RVR, ETR, SVR were 88.78%, 92.86% and 91.84% respectively. The total number of patients who did not have SVR were 8, of which 3 patients were non responsive to antiviral agents, and 5 patients showed evidence of relapse of HCV infection. Among the 5 patients with relapse, dose was not reduced in 2 patients, whereas dose reduction was done to 3 patients who showed adverse effects, such as hematologic disorders (anemia, leukopenia, thrombocytopenia), poor oral intake, and general weakness. Univariate analysis showed that the RVR was the only independent factor that affected the SVR(odds ratio=11.857, 95% confidence interval: 2.427-57.920, P<0.001). Conclusions: Our study showed that combination theraphy with peginterferon and ribavirin as an initial treatment for genotype 2 and 3 chronic hepatitis C is very effective, and that the SVR rate is significantly associated with the RVR and might be a useful response factor that is readily available in clinical practice, and especially for genotype 2 and 3 patients.
( Sang Bun Choi ),( Youn Jae Lee ),( Jae Ik Lee ),( Young Jin Song ),( Byoung Jin Choi ),( Jong Han Kim ),( Eun Uk Jung ),( Sung Jae Park ),( Sang Heon Lee ),( Ji Hyun Kim ),( Jung Sik Choi ),( Sam Ry 대한간학회 2011 Clinical and Molecular Hepatology(대한간학회지) Vol.17 No.3
Background/Aims: The reappearance rates of hepatitis C virus (HCV) RNA after a sustained virological response (SVR) have been reported to be 1-2%. We investigated the reappearance rate of HCV RNA after SVR in chronic hepatitis C (CHC) patients treated with pegylated interferon (PEG-IFN) and ribavirin. Methods: In total, 292 CHC patients who achieved an SVR after PEG-IFN and ribavirin treatment were included. They were treated with subcutaneous injections of either PEG-IFN-α 2a or 2b plus ribavirin orally. Liver function tests and qualitative HCV RNA assays were performed every 6 months during the follow-up period after an SVR. Results: Among the 292 patients, 224 (genotype 1, 92; genotype non-1, 132) were followed up for more than 6 months after SVR. These 224 patients were aged 48.1±11.5 years (mean±SD), and 129 of them were male. The median follow-up duration was 18 months (range 6-60 months). The reappearance rate of HCV RNA during follow-up was 0%. Two patients who achieved an SVR developed hepatocellular carcinoma during the follow-up period. Conclusions: An SVR was maintained in all CHC patients treated with PEG-IFN plus ribavirin during a median follow-up of 18 months. However, a screening test for hepatocellular carcinoma is needed for patients with an SVR. (Korean J Hepatol 2011;17:183-188)
( Keol Lee ),( Dong Hyun Sinn ),( Geum-youn Gwak ),( Hyun Chin Cho ),( Sin-ho Jung ),( Yong-han Paik ),( Moon Seok Choi ),( Joon Hyeok Lee ),( Kwang Cheol Koh ),( Seung Woon Paik ) 대한간학회 2016 Gut and Liver Vol.10 No.5
Background/Aims: Following sustained virological response (SVR) for chronic hepatitis C (CHC) infection, patients with advanced fibrosis require regular monitoring for hepatocellular carcinoma (HCC). The aspartate aminotransferase to platelet ratio index (APRI) is a simple noninvasive surrogate marker known to reflect fibrosis. Methods: We retrospectively analyzed 598 patients who achieved SVR with interferonbased therapy for CHC. Results: Over a median of 5.1 years of follow-up, there were eight patients diagnosed with HCC and a 5-year cumulative incidence rate of 1.3%. The median pretreatment APRI was 0.83, which decreased to 0.29 after achieving SVR (p<0.001). Both the pre- and posttreatment indices were associated with HCC development. The 5-year cumulative HCC incidence rates were 0% and 2.8% for patients with pretreatment APRI <1.0 and ≥1.0, respectively (p=0.001) and 0.8% and 12.8% for patients with posttreatment APRI <1.0 and ≥1.0, respectively (p<0.001). Pretreatment APRI at a cutoff of 1.0 had a 100% negative predictive value until 10 years after SVR. Conclusions: HCC development was observed among CHC patients who achieved SVR. The pre- and post-treatment APRI could stratify HCC risk, indicating that the APRI could be a useful marker to classify HCC risk in CHC patients who achieved SVR. However, given the small number of HCC patients, this finding warrants further validation. (Gut Liver 2016;10:796-802)
연구논문 : C형간염바이러스 유전자형 1b에 감염된 한국인 환자에서 인터페론 감수성 결정 영역의 유전자 돌연변이 양상
진영주 ( Young Joo Jin ),박윤경 ( Yoon Kyung Park ),윤귀준 ( Gui Jun Yun ),이한주 ( Han Chu Lee ),정숙향 ( Sook Hyang Jeong ),김강모 ( Gang Mo Kim ),임영석 ( Young Suk Lim ),정영화 ( Young Hwa Chung ),이영상 ( Yung Sang Lee ),서 대한간학회 2010 Clinical and Molecular Hepatology(대한간학회지) Vol.16 No.2
Background/Aims: The treatment response to interferon could differ with mutations in the interferon-sensitivity-determining region (ISDR) in patients infected with hepatitis C virus (HCV) genotype-1b (HCV-Ib). We examined the pattern of ISDR mutations and analyzed whether the number of amino acid substitutions influences the treatment response to peginterferon plus ribavirin in chronic hepatitis or cirrhotic patients infected with HCV-Ib. Methods: The study population comprised 52 patients who visited Seoul Asan Medical Center and Seoul National University Bundang Hospital from January 2006 to December 2008 and who received peginterferon alpha-2a (n=37) or -2b (n=15) plus ribavirin, and whose serum was stored. We analyzed the early virologic response, end-of-treatment response, and sustained virologic response (SVR), and examined the ISDR using direct sequencing. Results: The proportions of patients with ISDR mutation types of wild (0mutations), intermediate (1-3 mutations), and mutant (≥4 mutations) were 50.0%, 42.3%, and 7.7%,respectively, and the corresponding SVR rates were 63%, 50%, and 67% (p>0.05). The SVR rates were 59.4% and 50.0% in patients with <2 and ≥2 mutations, respectively (p>0.05). On univariate analysis, age was the only predictive factor for SVR (p=0.016). The pretreatment HCV RNA titer tended to be lower in those with SVR, but without statistical significance (p=0.069). Conclusions: The frequency of ISDR mutations was low in our cohort of Korean patients infected with HCV-Ib. Therefore, ISDR mutations might not contribute to the response to treatment with peginterferon plus ribavirin.
( Sung Yong Han ),( Hyun Young Woo ),( Jeong Heo ),( Sang Gyu Park ),( Sung Ik Pyeon ),( Young Joo Park ),( Dong Uk Kim ),( Gwang Ha Kim ),( Hyung Hoi Kim ),( Geun Am Song ),( Mong Cho ) 대한내과학회 2021 The Korean Journal of Internal Medicine Vol.36 No.3
Background/Aims: Real-world, clinical practice data are lacking about sofosbuvir/ ribavirin (SOF/RBV) treatment of Korean patients with hepatitis C virus genotype 2 (HCV GT2) infection. This study investigated the efficacy and safety of SOF/RBV in Korean patients with HCV GT2 infection and clinical factors predicting sustained virological response 12 weeks (SVR12) after the end of SOF/RBV treatment. Methods: A total of 181 patients with HCV GT2 with/without cirrhosis were treated with SOF/RBV for 16/12 weeks. Rapid virological response (RVR) was defined as non-detectable HCV RNA at 4 weeks. Results: The RVR rate was 80.7% (146/181), the end of treatment response rate was 97.8% (177/181) and the SVR12 rate was 92.8% (168/181). Of eight patients with relapse, four did not achieve RVR. Three patients had a history of hepatocellular carcinoma (HCC). Multivariable analysis showed that RVR (p = 0.015) and no previous history of HCC (p = 0.007) were associated with SVR12. Factors significantly contributing to RVR included cirrhosis, creatinine concentration, and pre-treatment HCV RNA level. SVR12 rate was significantly higher in RVR (+) than RVR (-) patients (95.2% vs. 82.9%, p = 0.011) and also significantly higher in patients without than with a history of HCC (94.1% vs. 72.7%, p = 0.008). During treatment, 80/181 patients (44.2%) experienced mild to moderate adverse events, with 32 (17.7%) requiring RBV dose reductions due to anemia. Conclusions: SOF/RBV treatment was effective and tolerable in HCV GT2 patients. RVR and no previous history of HCC were positive predictors of SVR12.
( Young Chang ),( Jeong-hoon Lee ),( Joon Yeul Nam ),( Hyo Young Lee ),( Hyeki Cho ),( Young Youn Cho ),( Eun Ju Cho ),( Su Jong Yu ),( Yoon Jun Kim ),( Jung-hwan Yoon ) 대한간학회 2017 춘·추계 학술대회 (KASL) Vol.2017 No.1
Aims: The concordance among end of treatment response (ETR) and sustained virologic response at week 12 (SVR12) and 24 (SVR24) has not been well evaluated in patients treated with interferon-free direct acting antiviral agents (DAA). We aimed to assess the correlation between ETR, SVR12, and SVR24. Methods: We conducted a single-center retrospective study including DAA-treated patients with chronic hepatitis C whose virologic response was evaluated after the end of treatment. Viral load was estimated with real-time quantitative RT-PCR (lower limit of detection, 12 IU/mL). Results: This study included 282 patients whose SVR12 was evaluated among 417 patients who finished DAA treatment as scheduled. ETR could accurately predicted SVR12 in 270 of the 282 patients (95.7%), making sensitivity of 98.5% (95% confidence interval, 96.2-99.6%), specificity of 38.5% (95% CI, 13.9-68.4%), positive predictive value (PPV) of 97.1% (95% CI, 95.6-98.1%), and negative predictive value of 55.6% (95% CI, 27.5-80.4%). Interestingly, 44.4% of patients without ETR (4 of 9) achieved SVR12. In contrast, 2.9% of patients with ETR (8 of 273) did not achieved SVR12. The results of SVR12 and SVR24 were identical in 98.7% of evaluated patients (75 of 76 patients). SVR12 could predict SVR12 with sensitivity of 100% (95% CI, 94.6-100.0%), specificity of 88.9% (95% CI, 51.8-99.7%), PPV of 98.5% (95% CI, 91.4-99.8%), and NPV of 100% (95% CI, 100-100%). Conclusions: ETR can accurately predict SVR12, which is also closely correlated with SVR24. Surprisingly, SVR12 was achieved in 44% of the patients who failed to achieve ETR, which might suggest delayed effect of DAA on HCV clearance.