Clevudine-induced viral response, associated with continued reduction of HBsAg titer, was durable after the withdrawal of therapy

Lee, Hyo Suk; Yoo, Byung Chul; Lee, Kwan Sik; Kim, Ju Hyun; Um, Soon Ho; Ryu, Soo Hyung; Lee, Young Suk; Kim, Young Soo; Yoo, Kwon; Han, Ji Yoon; Kim, Tae Hun; Yang, Jin Mo; Lee, Heon Ju; Chon, Chae Yoon; Cho, Mong; Han, Byung Hoon; Hwang, Seong Gyu; Byun, Kwan Soo; Chung, Young Hwa; Cho, Se Hyun; Koh, Kwang Cheol; Kim, Byung Ik; Kim, Haak Cheoul; Paik, Seung Woon; Lee, Myung Seok; Yoo, Hee Won; Han, C.J.

doi:10.1007/s00535-010-0354-x

Cited by 7 publications

(3 citation statements)

References 26 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The mean declines of HBsAg level from baseline were −0.03 ± 0.53, −0.18 ± 0.32, and −0.25 ± 0.47 log IU/ml in the clevudine 30 mg, 20 mg, and combination groups, respectively. In our study, HBsAg reduction was not obvious, although HBsAg reduction by clevudine has been published in previous papers [22, 23]. In consideration of the low level of baseline HBsAg (3.53–3.66 log IU/ml) in this study, we can presume that HBsAg reduction by clevudine is more predominant in patients with high baseline HBsAg levels.…”

Section: Discussionsupporting

confidence: 42%

A randomized, open-label study comparing low-dose clevudine plus adefovir combination therapy with clevudine monotherapy in naïve chronic hepatitis B patients

et al. 2014

Self Cite

View full text Add to dashboard Cite

PurposeClevudine 30 mg showed potent antiviral activity with a marked post-treatment antiviral effect. However, long-term treatment with clevudine monotherapy induced resistance and myopathy in some cases. The objective of this study is to evaluate the preliminary efficacy and safety of the combination of clevudine 20 mg and adefovir compared to clevudine monotherapy.MethodsSeventy-four patients were randomized to either a combination of clevudine 20 mg and adefovir or clevudine 20 or 30 mg and were treated for 2 years. The viral kinetics for 24 weeks, virological response [VR; hepatitis B virus (HBV) DNA less than 300 copies/ml], and the biochemical response [BR; normal alanine aminotransferase (ALT)] were assessed.ResultsThere was no difference in baseline characteristics among the three groups. Viral kinetics study showed no statistically significant difference among them during 24 weeks. The combination group showed 95 % virological response with a statistically significant difference compared to the clevudine 30 mg (67 %) and 20 mg (71 %) groups (p = 0.0376). Biochemical response rates were similar in all groups (78–94 %). No resistance was reported in the combination group, while 20 % of patients treated with clevudine 30 mg or 20 mg reported resistance during 2 years. Muscle-related symptoms such as myalgia (1 in clevudine 30 mg, 1 in the combination group) and muscle weakness (1 in clevudine 30 mg, 2 in clevudine 20 mg) were reported in five patients (7 %); of these, three patients discontinued the study.ConclusionWe concluded that the combination of clevudine 20 mg and adefovir produced a potent antiviral response together with a good resistance profile compared to clevudine monotherapy at 96 weeks in this pilot study.

show abstract

Section: Discussionsupporting

confidence: 42%

A randomized, open-label study comparing low-dose clevudine plus adefovir combination therapy with clevudine monotherapy in naïve chronic hepatitis B patients

et al. 2014

Self Cite

View full text Add to dashboard Cite

show abstract

“…Moreover, they could achieve in 75% of HDV infected woodchucks undetectable HDV RNA with clevudine treatment [59] . An HBsAg titer reduction by reducing the cccDNA during clevudine therapy was also found in humans [60] . In comparison to lamivudine, clevudine seems to be superior in HBeAg positive HBV.…”

Section: Main Results (S)mentioning

confidence: 81%

Molecular and clinical aspects of hepatitis D virus infections

Dastgerdi

Herbers²,

Tacke³

2012

WJV

View full text Add to dashboard Cite

“…There was no remarkable lactic acidosis and no permanent and irreversible myopathy damage in either this study or any of previously published case reports (unlike filauridine disaster) (25). Clevudine is known to possess prolonged potent antiviral activity after cessation of medication (6, 26). Moreover, the characteristic pharmacodynamic clearance of clevudine, which does not follow first-order kinetics as a function of time, may increase intracellular L-FMAU triphophate (L-FMAUTP) in long-term clevudine therapy.…”

Section: Discussionmentioning

confidence: 99%

Virological Response and Muscular Adverse Events during Long-Term Clevudine Therapy in Chronic Hepatitis B Patients

Kook

Young

et al. 2013

Hepat Mon

View full text Add to dashboard Cite

BackgroundRecently, several reports issued clevudine induced myopathy in the long term use.ObjectivesThe aim of this study was to investigate antiviral effects and adverse events of clevudine monotherapy in patients with chronic hepatitis B (CHB).Patients and MethodsThe subjects were 110 treatment-naïve CHB patients. They were treated with 30 mg clevudine/day for more than six months. Virological and biochemical tests, including that for serum creatine kinase (CK), were monitored at baseline and at 3-month intervals during treatment period.ResultsIn HBeAg-positive patients, the cumulative rates of virological response were 74.0 %, 68.5 %, and 67.3 % after one, two, and three years of clevudine treatment, respectively. Cumulative rates of HBeAg loss or seroconversion were 17.8 %, 30 %, and 31.5 % after one, two and, three years of clevudine treatment, respectively. In HBeAg-negative patients, the cumulative rates of virological response were 97.3 %, 100 %, and 94.6 %, respectively. Virological breakthrough occurred in 27 patients. The rtM204I mutation in HBV polymerase was predominantly detected. Muscular adverse events were observed in 15 patients. All patients with myopathy recovered after the cessation of clevudine monotherapy. Fluctuations in CK level during the clevudine treatment period were frequently observed irrespective of development of myopathy. Multiple episodes of CK elevation were significantly related to the development of myopathy.ConclusionsLong-term clevudine monotherapy is effective for suppression of serum HBV DNA level and normalization of serum alanine amino transaminase levels, but associated with occurrence of rtM204I mutation. Clevudine-induced muscular adverse events are not uncommon, although they are totally reversible after cessation of the treatment. Muscular adverse events and serum CK level should be carefully monitored during long-term treatment with clevudine.

show abstract

Clevudine-induced viral response, associated with continued reduction of HBsAg titer, was durable after the withdrawal of therapy

Abstract: The clevudine-induced viral response was durable in the majority of patients for 2 years after the withdrawal of treatment.

Cited by 7 publications

References 26 publications

A randomized, open-label study comparing low-dose clevudine plus adefovir combination therapy with clevudine monotherapy in naïve chronic hepatitis B patients

A randomized, open-label study comparing low-dose clevudine plus adefovir combination therapy with clevudine monotherapy in naïve chronic hepatitis B patients

Molecular and clinical aspects of hepatitis D virus infections

Virological Response and Muscular Adverse Events during Long-Term Clevudine Therapy in Chronic Hepatitis B Patients

Contact Info

Product

Resources

About