A comparison of 48-week treatment efficacy between clevudine and entecavir in treatment-naïve patients with chronic hepatitis B

Shin, Su Rin; Yoo, Byung Chul; Choi, Moon Seok; Lee, Dong Hoon; Song, Seung Hwan; Lee, Joon Hyoek; Koh, Kwang Cheol; Paik, Seung Woon

doi:10.1007/s12072-010-9238-7

Cited by 19 publications

(14 citation statements)

References 31 publications

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“…Similarly, our study also showed high cumulative rates of biochemical response (serum ALT <40 IU/L) (77.6% at 12 months, 86.2% at 24 months, and 86.2% at 36 months), and this was not significantly different between HBeAg-positive and negative patients. In addition, the rate of HBeAg loss or HBeAg seroconversion in our study (17.6% at 12 months, 23.5% at 24 months, and 23.5% at 36 months) was similar to previous studies (18% to 25% at week 48) 5,6,9…”

Section: Discussionsupporting

confidence: 91%

“…In previous studies, CLV treatment led to a high frequency (78% to 84.7%) of serum ALT normalization at 48 weeks 5-9. Similarly, our study also showed high cumulative rates of biochemical response (serum ALT <40 IU/L) (77.6% at 12 months, 86.2% at 24 months, and 86.2% at 36 months), and this was not significantly different between HBeAg-positive and negative patients.…”

Section: Discussionsupporting

confidence: 84%

“…In a randomized study, no resistance was found in the CLV group during the 48-week treatment period 6. However, several studies from Korea reported that 48 weeks of CLV therapy resulted in a viral breakthrough incidence ranging from 3.4% to 9.4% in treatment-naïve patients with CHB 7-9. In our study, the cumulative rates of viral breakthrough substantially increased with treatment duration from 6.6% at month 12 to 30.0% at month 36.…”

Section: Discussionmentioning

confidence: 99%

“…In a double-blind randomized study, 48 weeks of CLV treatment was superior to lamivudine in suppressing HBV replication without the emergence of viral breakthrough in patients with hepatitis B e antigen (HBeAg)-positive CHB 6. However, several studies reported that 48 weeks of CLV therapy resulted in an incidence of virologic breakthrough ranging from 3.4% to 9.4% in treatment-naïve patients with CHB 7-9. Furthermore, several studies showed that long-term CLV therapy induces the depletion of mitochondrial DNA and leads to mitochondrial myopathy associated with myonecrosis 10-12.…”

Section: Introductionmentioning

confidence: 99%

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Long-Term Treatment Efficacy and Safety of Clevudine Therapy in Naïve Patients with Chronic Hepatitis B

Choung¹,

Kim²,

Jeon³

et al. 2012

Gut Liver

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Background/AimsClevudine (CLV) has potent antiviral activity against chronic hepatitis B (CHB) virus infection. The long-term efficacy and safety of CLV therapy in naïve patients with CHB were investigated.MethodsIn this retrospective study, 152 naïve Korean patients with CHB who received 30 mg of CLV once daily for at least 12 months were investigated.ResultsThe cumulative rates at months 12, 24, and 36, respectively, were 65.8%, 74.7%, and 74.7% for undetectable serum hepatitis B virus (HBV) DNA (<12 IU/mL); 77.6%, 86.2%, and 86.2% for normalization of serum alanine aminotransferase (<40 IU/L); 17.6%, 23.5%, and 23.5% for hepatitis B e antigen (HBeAg) loss or seroconversion; and 6.6%, 22.5%, and 30.0% for viral breakthrough. HBeAg positivity (p=0.010), baseline serum HBV DNA level ≥6 log10 IU/mL (p=0.032) and detectable serum HBV DNA (≥12 IU/mL) at week 24 (p=0.023) were independently associated with the development of viral breakthrough. During follow-up, CLV-induced myopathy developed in 5.9% of patients.ConclusionsThe results of long-term CLV therapy for the treatment of naïve patients with CHB showed a high frequency of antiviral resistance and substantial associated myopathy. Therefore, we advise that CLV should not be used as a first-line treatment for naïve patients given the availability of other more potent, safer antiviral agents.

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Section: Discussionsupporting

confidence: 91%

Section: Discussionsupporting

confidence: 84%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Long-Term Treatment Efficacy and Safety of Clevudine Therapy in Naïve Patients with Chronic Hepatitis B

Choung¹,

Kim²,

Jeon³

et al. 2012

Gut Liver

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“…In comparison to lamivudine, clevudine seems to be superior in HBeAg positive HBV. Compared to entecavir, in chronic HBV infected patients clevudine could reduce viral load similar than entecavir, but higher rates of virological breakthrough and significantly more myopathy was observed [61] , indicating that clevudine has a higher adverse event profile.…”

Section: Main Results (S)mentioning

confidence: 99%

Molecular and clinical aspects of hepatitis D virus infections

Dastgerdi

Herbers²,

Tacke³

2012

WJV

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Adverse events of nucleos(t)ide analogues for chronic hepatitis B: a systematic review

et al. 2020

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Nucleos(t)ide analogues (NAs) are the main drug category used in chronic hepatitis B (CHB) treatment. Despite the fact that NAs have a favourable safety profile, undesired adverse events (AEs) may occur during the treatment of CHB. Given the eminent number of patients currently receiving NAs, even a small risk of any of these toxicities can represent a major medical issue. The main objective of this review was to analyse information available on AEs associated with the use of NAs in published studies. We choose the following MesH terms for this systematic review: chronic hepatitis B, side effects and treatment. All articles published from 1 January 1990 up to 19 February 2018 in MEDLINE of PubMed, EMBASE, the Cochrane Library and LILACS databases were searched. A total of 120 articles were selected for analysis, comprising 6419 patients treated with lamivudine (LAM), 5947 with entecavir (ETV), 3566 with tenofovir disoproxil fumarate (TDF), 3096 with telbivudine (LdT), 1178 with adefovir dipivoxil (ADV) and 876 with tenofovir alafenamide (TAF). The most common AEs in all NAs assessed were abdominal pain/discomfort, nasopharyngitis/upper respiratory tract infections, fatigue, and headache. TAF displays the highest density of AEs per patient treated among NAs (1.14 AE/treated patient). In conclusion, treatment of CHB with NAs is safe, with a low incidence of AEs. Despite the general understanding TAF being safer than TDF, the number of patients treated with TAF still is too small in comparison to other NAs to consolidate an accurate safety profile. PROSPERO Registration No. CRD42018086471

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A comparison of 48-week treatment efficacy between clevudine and entecavir in treatment-naïve patients with chronic hepatitis B

Abstract: Mean reduction of viral loads was similar between clevudine and entecavir groups during 48 weeks. However, virologic breakthrough and significant myopathy were noted only in clevudine-treated patients. Therefore, more attention should be paid to patients receiving clevudine.

Cited by 19 publications

References 31 publications

Long-Term Treatment Efficacy and Safety of Clevudine Therapy in Naïve Patients with Chronic Hepatitis B

Long-Term Treatment Efficacy and Safety of Clevudine Therapy in Naïve Patients with Chronic Hepatitis B

Molecular and clinical aspects of hepatitis D virus infections

Adverse events of nucleos(t)ide analogues for chronic hepatitis B: a systematic review

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