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Tenofovir disoproxil fumarate monotherapy for nucleos(t)ide-naïve chronic hepatitis B patients in Korea: data from the clinical practice setting in a single-center cohort.

Ahn SS, Chon YE, Kim BK, Kim SU, Kim do Y, Ahn SH, Han KH, Park JY - Clin Mol Hepatol (2014)

Bottom Line: There was no virological breakthrough after initiating TDF.However, no serious life-threatening side effect was noted.In a clinical practice setting, TDF was safe and highly effective when administered for 12 months to Korean treatment-naïve CHB patients.

View Article: PubMed Central - PubMed

Affiliation: Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.

ABSTRACT

Background/aims: This study assessed the antiviral efficacy and safety of tenofovir disoproxil fumarate (TDF) for up to 12 months in Korean treatment-naïve chronic hepatitis B (CHB) patients.

Methods: A total of 411 treatment-naïve CHB patients who had been treated with TDF for at least 3 months (median 5.6) were consecutively enrolled. Clinical, biochemical, virological parameters and treatment adherence were routinely assessed every 3 months.

Results: The median age was 51.3 years, 63.0% of the patients were male, 49.6% were HBeAg (+), and 210 patients had liver cirrhosis. The median baseline HBV DNA was 5.98 (SD 1.68) log10 IU/mL. Among the patients completing week 48, 83.3% had a complete virologic response (CVR, <12 IU/mL by HBV PCR assay), and 88.2% had normalized levels of alanine aminotransferase (ALT). The cumulative probabilities of CVR at 3, 6, 9 and 12 months were 22.8%, 53.1%, 69.3% and 85.0%. During the follow-up period, 9.8% patients achieved HBeAg loss and 7.8% patients achieved HBeAg seroconversion. There was no virological breakthrough after initiating TDF. The most common TDF-related adverse event was gastrointestinal upset, and three patients discontinued TDF therapy. However, no serious life-threatening side effect was noted.

Conclusions: In a clinical practice setting, TDF was safe and highly effective when administered for 12 months to Korean treatment-naïve CHB patients.

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Cumulative probability of complete virological response through TDF treatment.
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Figure 1: Cumulative probability of complete virological response through TDF treatment.

Mentions: The proportion of patients with CVR is shown in Table 2. After 12-month treatment, 83.3% of total patients showed CVR. In the study population, virological response rate was quite similar and irrelevant to HBeAg and liver cirrhosis status. The cumulative probability of CVR is shown at Fig 1. The cumulative probabilities of CVR at 3, 6, 9 and 12 months were 22.8 %, 53.1%, 69.3% and 85.0%. At month 12, mean decline in serum HBV DNA level was -4.52 (log 5.92 in baseline and log 1.35 in month 12), which was statistically significant (95% CI 4.12-4.79; P<0.001) (Fig 2.). In HBeAg positive and negative patients, mean decrease of HBV DNA after 12 month was -5.19 and -3.94 respectively, while in patients with liver cirrhosis and without cirrhosis was -4.21 and -4.96. During 12 month follow-up period, no patient showed virological breakthrough or antiviral agent resistance.


Tenofovir disoproxil fumarate monotherapy for nucleos(t)ide-naïve chronic hepatitis B patients in Korea: data from the clinical practice setting in a single-center cohort.

Ahn SS, Chon YE, Kim BK, Kim SU, Kim do Y, Ahn SH, Han KH, Park JY - Clin Mol Hepatol (2014)

Cumulative probability of complete virological response through TDF treatment.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4197174&req=5

Figure 1: Cumulative probability of complete virological response through TDF treatment.
Mentions: The proportion of patients with CVR is shown in Table 2. After 12-month treatment, 83.3% of total patients showed CVR. In the study population, virological response rate was quite similar and irrelevant to HBeAg and liver cirrhosis status. The cumulative probability of CVR is shown at Fig 1. The cumulative probabilities of CVR at 3, 6, 9 and 12 months were 22.8 %, 53.1%, 69.3% and 85.0%. At month 12, mean decline in serum HBV DNA level was -4.52 (log 5.92 in baseline and log 1.35 in month 12), which was statistically significant (95% CI 4.12-4.79; P<0.001) (Fig 2.). In HBeAg positive and negative patients, mean decrease of HBV DNA after 12 month was -5.19 and -3.94 respectively, while in patients with liver cirrhosis and without cirrhosis was -4.21 and -4.96. During 12 month follow-up period, no patient showed virological breakthrough or antiviral agent resistance.

Bottom Line: There was no virological breakthrough after initiating TDF.However, no serious life-threatening side effect was noted.In a clinical practice setting, TDF was safe and highly effective when administered for 12 months to Korean treatment-naïve CHB patients.

View Article: PubMed Central - PubMed

Affiliation: Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.

ABSTRACT

Background/aims: This study assessed the antiviral efficacy and safety of tenofovir disoproxil fumarate (TDF) for up to 12 months in Korean treatment-naïve chronic hepatitis B (CHB) patients.

Methods: A total of 411 treatment-naïve CHB patients who had been treated with TDF for at least 3 months (median 5.6) were consecutively enrolled. Clinical, biochemical, virological parameters and treatment adherence were routinely assessed every 3 months.

Results: The median age was 51.3 years, 63.0% of the patients were male, 49.6% were HBeAg (+), and 210 patients had liver cirrhosis. The median baseline HBV DNA was 5.98 (SD 1.68) log10 IU/mL. Among the patients completing week 48, 83.3% had a complete virologic response (CVR, <12 IU/mL by HBV PCR assay), and 88.2% had normalized levels of alanine aminotransferase (ALT). The cumulative probabilities of CVR at 3, 6, 9 and 12 months were 22.8%, 53.1%, 69.3% and 85.0%. During the follow-up period, 9.8% patients achieved HBeAg loss and 7.8% patients achieved HBeAg seroconversion. There was no virological breakthrough after initiating TDF. The most common TDF-related adverse event was gastrointestinal upset, and three patients discontinued TDF therapy. However, no serious life-threatening side effect was noted.

Conclusions: In a clinical practice setting, TDF was safe and highly effective when administered for 12 months to Korean treatment-naïve CHB patients.

Show MeSH
Related in: MedlinePlus