Telbivudine in combination with adefovir versus adefovir monotherapy in HBeAg-positive, lamivudine-resistant chronic hepatitis B

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http://www.springerlink.com/content/u22221225l0783r5/

Hepatology International

DOI: 10.1007/s12072-011-9314-7

Online Firstâ„¢

Original Article

Telbivudine in combination with adefovir versus adefovir monotherapy in

HBeAg-positive, lamivudine-resistant chronic hepatitis B

Sang-Hoon Ahn, Young-Oh Kweon, Seung-Woon Paik, Joo-Hyun Sohn, Kwan-Sik Lee,

Dong Joon Kim, Teerha Piratvisuth, Man Fung Yuen, Anuchit Chutaputti and

You-Chen Chao, et al.

Abstract

Purpose

Lamivudine (LAM) resistance is common on lamivudine monotherapy for chronic

hepatitis B. This study examined the safety and efficacy of telbivudine (LDT)

given with adefovir (ADV) versus ADV monotherapy in patients with chronic,

lamivudine-resistant HBV infection.

Methods

An open-label, 96 week study with planned recruitment of 150 HBeAg-positive,

lamivudine-experienced Asian patients with a confirmed YMDD resistance mutation,

randomized 1:1 to receive ADV alone or with LDT. The study was terminated early

due to difficulty in enrolling monotherapy patients. At termination, 42 patients

had received study medication for 8–61 weeks. Due to incomplete enrolment,

summary statistics only were prepared, without significance testing.

Results

A total of 42 patients underwent rescue therapy (switch to ADV or LDT + ADV; n =

21 per group). Median treatment duration was 48 weeks in both groups. HBV DNA

changes from baseline were greater in the LDT + ADV arm at all time points (Week

48: −7.4 log10 vs. −4.9 log10 copies/ml), and serum DNA was undetectable

(<300 copies/mL) at week 48 in 38.5% (5/13) on LDT + ADV versus 0% (0/9) on ADV

monotherapy Two patients (9.6%) on ADV monotherapy experienced virologic

breakthrough without evidence of ADV resistance, but none on LDT + ADV; and no

confirmed ADV resistance was observed in any on-treatment sample. HBeAg loss

occurred in three patients on LDT + ADV and one patient on ADV monotherapy

through week 48. Safety profiles were similar between the arms.

Conclusion

LDT + ADV combination treatment showed better outcomes against lamivudine

resistant HBV than ADV alone, with a similar safety profile.

[Guest guest]

http://www.springerlink.com/content/u22221225l0783r5/

Hepatology International

DOI: 10.1007/s12072-011-9314-7

Online Firstâ„¢

Original Article

Telbivudine in combination with adefovir versus adefovir monotherapy in

HBeAg-positive, lamivudine-resistant chronic hepatitis B

Sang-Hoon Ahn, Young-Oh Kweon, Seung-Woon Paik, Joo-Hyun Sohn, Kwan-Sik Lee,

Dong Joon Kim, Teerha Piratvisuth, Man Fung Yuen, Anuchit Chutaputti and

You-Chen Chao, et al.

Abstract

Purpose

Lamivudine (LAM) resistance is common on lamivudine monotherapy for chronic

hepatitis B. This study examined the safety and efficacy of telbivudine (LDT)

given with adefovir (ADV) versus ADV monotherapy in patients with chronic,

lamivudine-resistant HBV infection.

Methods

An open-label, 96 week study with planned recruitment of 150 HBeAg-positive,

lamivudine-experienced Asian patients with a confirmed YMDD resistance mutation,

randomized 1:1 to receive ADV alone or with LDT. The study was terminated early

due to difficulty in enrolling monotherapy patients. At termination, 42 patients

had received study medication for 8–61 weeks. Due to incomplete enrolment,

summary statistics only were prepared, without significance testing.

Results

A total of 42 patients underwent rescue therapy (switch to ADV or LDT + ADV; n =

21 per group). Median treatment duration was 48 weeks in both groups. HBV DNA

changes from baseline were greater in the LDT + ADV arm at all time points (Week

48: −7.4 log10 vs. −4.9 log10 copies/ml), and serum DNA was undetectable

(<300 copies/mL) at week 48 in 38.5% (5/13) on LDT + ADV versus 0% (0/9) on ADV

monotherapy Two patients (9.6%) on ADV monotherapy experienced virologic

breakthrough without evidence of ADV resistance, but none on LDT + ADV; and no

confirmed ADV resistance was observed in any on-treatment sample. HBeAg loss

occurred in three patients on LDT + ADV and one patient on ADV monotherapy

through week 48. Safety profiles were similar between the arms.

Conclusion

LDT + ADV combination treatment showed better outcomes against lamivudine

resistant HBV than ADV alone, with a similar safety profile.