Comparison of Clevudine and Entecavir for Treatment-naive Patients With Chronic Hepatitis B Virus Infection: Two Year Follow-up Data

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J Clin Gastroenterol. 2011 May 25. [Epub ahead of print]

Comparison of Clevudine and Entecavir for Treatment-naive Patients With Chronic

Hepatitis B Virus Infection: Two Year Follow-up Data.

Yoon EL, Yim HJ, Lee HJ, Lee YS, Kim JH, Jung ES, Kim JH, Seo YS, Yeon JE, Lee

HS, Um SH, Byun KS.

Source

Division of Gastroenterology and Hepatology, Department of Internal Medicine,

Korea University College of Medicine, Seoul, Korea.

Abstract

BACKGROUND/AIM:

Clevudine and entecavir are highly potent antiviral agents being used in

treatment of chronic hepatitis B. However, no data comparing clinical efficacy

and safety of these 2 drugs over a long-term period is available. The aims of

this study are to compare virologic, biochemical, and serologic response rates

of clevudine and entecavir, as well as treatment failure rates up to 2 years.

METHODS:

Data of patients who started clevudine (n=86) or entecavir (n=159) as a primary

treatment for chronic hepatitis B at Korea University Ansan or Guro Hospital

between January 2007 and June 2008 were analyzed.

RESULTS:

Treatment responses were compared at 3-month intervals up to 24 months. Per

protocol analysis showed no difference in virologic responses between the 2

groups at all time points, except at 18 months. When analyzed on

intention-to-treat basis for virologic response at 24 months, the response rates

were 45.3% in the clevudine group and 72.3% in the entecavir group, which are

significantly different (P<0.001). Rates of biochemical response and HBeAg

seroconversion were not significantly different between the groups at all time

points. Up to 24 months, antiviral resistance developed in 18 patients (24.4%)

in the clevudine group. Clevudine was discontinued owing to muscle-related

problems in 10 patients (11.6%).

CONCLUSIONS:

Although both drugs showed potent antiviral activity, entecavir showed better

virologic response at 24 months, primarily owing to treatment failures in the

clevudine group that were associated with development of drug resistance and

muscle-related problems.

PMID: 21617542 [PubMed - as supplied by publisher]

[Guest guest]

J Clin Gastroenterol. 2011 May 25. [Epub ahead of print]

Comparison of Clevudine and Entecavir for Treatment-naive Patients With Chronic

Hepatitis B Virus Infection: Two Year Follow-up Data.

Yoon EL, Yim HJ, Lee HJ, Lee YS, Kim JH, Jung ES, Kim JH, Seo YS, Yeon JE, Lee

HS, Um SH, Byun KS.

Source

Division of Gastroenterology and Hepatology, Department of Internal Medicine,

Korea University College of Medicine, Seoul, Korea.

Abstract

BACKGROUND/AIM:

Clevudine and entecavir are highly potent antiviral agents being used in

treatment of chronic hepatitis B. However, no data comparing clinical efficacy

and safety of these 2 drugs over a long-term period is available. The aims of

this study are to compare virologic, biochemical, and serologic response rates

of clevudine and entecavir, as well as treatment failure rates up to 2 years.

METHODS:

Data of patients who started clevudine (n=86) or entecavir (n=159) as a primary

treatment for chronic hepatitis B at Korea University Ansan or Guro Hospital

between January 2007 and June 2008 were analyzed.

RESULTS:

Treatment responses were compared at 3-month intervals up to 24 months. Per

protocol analysis showed no difference in virologic responses between the 2

groups at all time points, except at 18 months. When analyzed on

intention-to-treat basis for virologic response at 24 months, the response rates

were 45.3% in the clevudine group and 72.3% in the entecavir group, which are

significantly different (P<0.001). Rates of biochemical response and HBeAg

seroconversion were not significantly different between the groups at all time

points. Up to 24 months, antiviral resistance developed in 18 patients (24.4%)

in the clevudine group. Clevudine was discontinued owing to muscle-related

problems in 10 patients (11.6%).

CONCLUSIONS:

Although both drugs showed potent antiviral activity, entecavir showed better

virologic response at 24 months, primarily owing to treatment failures in the

clevudine group that were associated with development of drug resistance and

muscle-related problems.

PMID: 21617542 [PubMed - as supplied by publisher]