Clevudine is highly efficacious in hepatitis B e antigen-negative chronic hepatitis B with durable off-therapy viral suppression

Yoo, Byung Chul; Kim, Ju Hyun; Kim, Tae-Hun; Koh, Kwang Cheol; Um, Soon-Ho; Kim, Young Soo; Lee, Kwan Sik; Han, Byung Hoon; Chon, Chae Yoon; Han, Ji-Hye; Ryu, Soo Hyung; Kim, Haak Cheoul; Byun, Kwan Soo; Hwang, Seong Gyu; Kim, Byung-Ik; Cho, Mong; Yoo, Kwon; Lee, Heon-Ju; Hwang, Jae Seok; Kim, Yun Soo; Lee, Young-Suk; Choi, Sung‐Kyu; Lee, Youn-Jae; Yang, Jung–Min; Park, Joong-Won; Lee, Myung-Seok; Kim, Dae‐Ghon; Chung, Young‐Hwa; Cho, Se-Hyun; Choi, Jong-Young; Kweon, Young-Oh; Lee, Heon Young; Jeong, Sook‐Hyang; Yoo, Hee-Won; Lee, Hyo‐Suk

doi:10.1002/hep.21800

Cited by 106 publications

(114 citation statements)

References 41 publications

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“…During 24 weeks of clevudine therapy, the rates of ALT normalization were 68.2% in patients with HBeAg-positive chronic hepatitis B 12 and 74.6% in patients with HBeAg-negative chronic hepatitis B. 13 Our data showed slightly lower rates of ALT normalization, specifically, 62.5% and 66.7% in the CHB/ HCC and CHB groups, respectively. In our study, 15 patients of the CHI/HCC group and 6 patients of the CHI group displayed normal ALT levels in a baseline study and they were excluded in the analysis of ALT normalization.…”

Section: Discussioncontrasting

confidence: 46%

“…12,13 In our study, median changes in serum HBV DNA levels at 24 weeks in the CHB/HCC and CHB groups were -2.7 and -1.8 log 10 copies/mL, respectively. This relatively small reduction in serum HBV DNA levels may be due to reduced baseline DNA levels and higher rates of lower baseline ALT levels in our study population (Tables 1, 2), compared with those reported previously; 6.6-6.3 vs 8.29-6.92 log 10 copies/mL, 68.5% vs 31.8-26.4% ALT <2X ULN at baseline, respectively.…”

Section: Discussionmentioning

confidence: 50%

“…This relatively small reduction in serum HBV DNA levels may be due to reduced baseline DNA levels and higher rates of lower baseline ALT levels in our study population (Tables 1, 2), compared with those reported previously; 6.6-6.3 vs 8.29-6.92 log 10 copies/mL, 68.5% vs 31.8-26.4% ALT <2X ULN at baseline, respectively. 12,13 Owing to low efficacy, antiviral treatment is not generally recommended to HBV-positive patients with serum HBV DNA levels >20,000 IU/mL and normal or minimally elevated ALT. 19 Careful consideration of the patient age, severity of liver disease, likelihood of response, and potential adverse events is essential prior to initiation of treatment.…”

Section: Discussionmentioning

confidence: 99%

“…A unique advantageous characteristic of clevudine is prolonged suppression of viral replication even after withdrawal of treatment, which has been demonstrated both in vitro and in vivo. 9,[11][12][13] Clinical effects of clevudine have been reported in patients with HBeAg-positive or -negative chronic hepatitis B. However, current knowledge on the effects of clevudine is insufficient, and the influence of this drug in HBV-related cirrhosis or HCC patients remains to be established.…”

Section: Introductionmentioning

confidence: 99%

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Clinical and Virological Responses to Clevudine Therapy of Hepatocelluar Carcinoma Patients with Chronic Hepatitis B

Woo¹,

Park²,

Lee³

et al. 2011

Gut Liver

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Background/Aims: The clinical effects of clevudine have been reported in patients with chronic hepatitis B virus infections (CHIs). In this investigation, we assessed whether clevudine induced biochemical and virological improvements in hepatocellular carcinoma (HCC) patients with CHI. Methods: Fifty-four patients who received 30 mg clevudine for more than 24 weeks between 2007 and 2009 at the National Cancer Center Hospital, Korea, were enrolled. Among these cases, 39 had HCC (CHI/HCC group) and 15 did not (CHI group). Results: In relation to the CHI group, the CHI/HCC group was older (55.5 years.) and had a higher liver cirrhosis rate (79.5%) (p<0.05). Median changes in serum hepatitis B virus (HBV) DNA levels from baseline at weeks 12, 24, and 36 of treatment in the CHI/HCC group were not signifi cantly different from those of the CHI group (-2.3, -2.7, -2.6 vs -1.7, -1.8, -2.4, respectively). HBV DNA <2,000 copies/mL was achieved in 76.5% of the CHI/HCC group at 24 weeks. Rates of ALT normalization in the CHI/HCC and CHI groups were 62.5% and 66.7%, respectively (p>0.05). Liver function was preserved with clevudine treatment in patients displaying response or stable disease under anti-cancer therapy. Four patients (7.4%) developed viral resistance during clevudine therapy. Among these, one was naïve, and three had previously received antiviral therapy. One CHI/HCC patient (1.9%) discontinued clevudine treatment due to symptomatic myopathy. Conclusions: Our findings clearly indicate that clevudine has comparable antiviral and biochemical effects in patients with CHI and with CHI/HCC and preserves the underlying liver function in HBV-related HCC patients. (Gut Liver 2011;5:82-87) HBV re-activation and chronic hepatitis B exacerbation. In addition, high HBV load prior to chemotherapy has an adverse effect on the survival of HCC patients with chronic HBV infection (CHI). 8 These findings suggest that incorporation of antiviral therapies to reduce the HBV viral load should be considered in the management of HBV-related HCC. Antiviral treatment may render HBV-related HCC patients more tolerant of HCC therapy, ultimately leading to better prognosis. A previous study by our group showed for the first time that lamivudine has comparable antiviral effects in patients with CHI and CHI/HCC and improves underlying liver function in the latter group. MATERIALS AND METHODS PatientsThis study is a retrospective evaluation of 54 CHI patients receiving 30 mg clevudine (Levovir ; Buckwang Pharmaceutical Co., Seoul, Korea) once a day for at least 6 months from August 2007 to February 2009 at the National Cancer Center Hospital (Goyang, Korea). Among the patients, 39 had chronic hepatitis B infection and HCC (CHI/HCC group), and 15 had CHI without HCC (CHI group). Patients with other viral infections, including hepatitis C, D, and human immunodeficiency virus, were excluded. All patients from both groups contained serum HBV DNA >10 5 copies/mL, as assessed using the branched DNA method. Moreover, all patients displayed ser...

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Section: Discussioncontrasting

confidence: 46%

Section: Discussionmentioning

confidence: 50%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Clinical and Virological Responses to Clevudine Therapy of Hepatocelluar Carcinoma Patients with Chronic Hepatitis B

Woo¹,

Park²,

Lee³

et al. 2011

Gut Liver

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“…In humans, clevudine 10, 50, 100, or 200 mg/day for 28 days can reduce the median HBV DNA by -2.5, -2.7, -3, and -2.6 log 10 , respectively. More importantly, this suppression of antiviral activity is maintained at 12 and 24 weeks post-treatment [125][126][127][128].…”

Section: Clevudinementioning

confidence: 99%

Recent data on treatment of chronic hepatitis B with nucleos(t)ide analogues

Leung

2008

Hepatol Int

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Forty years ago in 1967, Professor Blumberg discovered the Australian Antigen, later known as the hepatitis B surface antigen, and was awarded the Nobel Prize. This discovery enables the diagnosis of hepatitis B virus (HBV) infection and defines its epidemiology. Viral hepatitis B infection affects global health situation, and chronic hepatitis B (CHB) is particularly serious in the Asia-Pacific region. HBV vaccines created the first breakthrough in HBV prevention. Through universal HBV vaccination program for the newborns, promoted since the mid-1980s, the main route that perpetuates chronic infection from mother to child is curbed. Most children and young adults now have immunity against HBV infection. The next breakthrough comes with therapy for CHB. This prevents progression to cirrhosis and hepatocellular carcinoma. Standard interferon therapy with modest efficacy has been largely replaced by therapy with nuclos(t)ide analogues or pegylated interferons alfa-2a and -2b. Lamivudine was approved by the FDA USA in 1998, followed by adefovir dipivoxil in 2002, entecavir in 2005, and telbivudine in 2006. Clevudine, tenofovir, and many promising candidates are in different stages of development and clinical trial. This paper critically reviews recent data published or presented since the APASL Consensus and Guideline Update of 2005. Clinical efficacy mostly in patients with raised serum alanine aminotransferase will be analyzed.

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Hepatitis B and D

Lok

Negro

2011

Schiff's Diseases of the Liver

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Clevudine is highly efficacious in hepatitis B e antigen-negative chronic hepatitis B with durable off-therapy viral suppression

Abstract: A 24-week clevudine therapy was well-tolerated and showed potent and sustained antiviral effect without evidence of viral resistance in e-CHB patients. However, treatment for longer than 24 weeks would be needed to achieve durable remission.

Cited by 106 publications

References 41 publications

Clinical and Virological Responses to Clevudine Therapy of Hepatocelluar Carcinoma Patients with Chronic Hepatitis B

Clinical and Virological Responses to Clevudine Therapy of Hepatocelluar Carcinoma Patients with Chronic Hepatitis B

Recent data on treatment of chronic hepatitis B with nucleos(t)ide analogues

Hepatitis B and D

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