12-week clevudine therapy showed potent and durable antiviral activity in HBeAg-

[Guest guest]

epatology. 2006 Apr 20;43(5):982-988 [Epub ahead of print]

A 12-week clevudine therapy showed potent and durable antiviral activity in

HBeAg-positive chronic hepatitis B.

Lee HS, Chung YH, Lee K, Byun KS, Paik SW, Han JY, Yoo K, Yoo HW, Lee JH,

Yoo BC.

Seoul National University Hospital, Seoul, South Korea.

Clevudine is a nucleoside analog with an unnatural beta-L configuration. In

a phase I/II clinical trial, once daily doses ranging from 10 to 200 mg for

28 days were well tolerated, and produced significant antiviral activity.

The present study was conducted to assess the degree and durability of the

antiviral response to 12 weeks of clevudine treatment, and to investigate

its safety and tolerability. A total of 98 patients with HBeAg-positive

chronic hepatitis B were randomized to placebo (n = 32), 30-mg clevudine (n

= 32), and 50-mg clevudine (n = 34) groups. Patients were followed up after

12 weeks of treatment for a further 24 weeks off-therapy. Median serum

hepatitis B virus DNA reductions from baseline at week 12 were 0.20, 4.49,

and 4.45 log(10) copies/mL in the placebo, 30-mg clevudine, and 50-mg

clevudine groups, respectively (P < .0001). Posttreatment antiviral

activities were sustained, with 3.32 and 2.99 log(10) reductions at week 12

off-therapy and 2.28 and 1.40 log(10) reductions at week 24 off-therapies in

the 30- and 50-mg clevudine groups, respectively. Median serum alanine

aminotransferase (ALT) levels decreased markedly from baseline during

clevudine treatment and were maintained below the upper limit of normal

throughout the 24 weeks off-therapy in the two clevudine-treated groups. The

incidences of adverse events and treatment-emergent grade 3 or 4 laboratory

abnormalities were similar for the three groups. In conclusion, clevudine

showed potent antiviral activity during therapy and induced a sustained

posttreatment antiviral effect for 6 months after a 12-week treatment

period, and this was associated with a sustained normalization of ALT

levels. (HEPATOLOGY 2006;43:982-988.).

PMID: 16628625 [PubMed - as supplied by publisher]

_________________________________________________________________

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[Guest guest]

epatology. 2006 Apr 20;43(5):982-988 [Epub ahead of print]

A 12-week clevudine therapy showed potent and durable antiviral activity in

HBeAg-positive chronic hepatitis B.

Lee HS, Chung YH, Lee K, Byun KS, Paik SW, Han JY, Yoo K, Yoo HW, Lee JH,

Yoo BC.

Seoul National University Hospital, Seoul, South Korea.

Clevudine is a nucleoside analog with an unnatural beta-L configuration. In

a phase I/II clinical trial, once daily doses ranging from 10 to 200 mg for

28 days were well tolerated, and produced significant antiviral activity.

The present study was conducted to assess the degree and durability of the

antiviral response to 12 weeks of clevudine treatment, and to investigate

its safety and tolerability. A total of 98 patients with HBeAg-positive

chronic hepatitis B were randomized to placebo (n = 32), 30-mg clevudine (n

= 32), and 50-mg clevudine (n = 34) groups. Patients were followed up after

12 weeks of treatment for a further 24 weeks off-therapy. Median serum

hepatitis B virus DNA reductions from baseline at week 12 were 0.20, 4.49,

and 4.45 log(10) copies/mL in the placebo, 30-mg clevudine, and 50-mg

clevudine groups, respectively (P < .0001). Posttreatment antiviral

activities were sustained, with 3.32 and 2.99 log(10) reductions at week 12

off-therapy and 2.28 and 1.40 log(10) reductions at week 24 off-therapies in

the 30- and 50-mg clevudine groups, respectively. Median serum alanine

aminotransferase (ALT) levels decreased markedly from baseline during

clevudine treatment and were maintained below the upper limit of normal

throughout the 24 weeks off-therapy in the two clevudine-treated groups. The

incidences of adverse events and treatment-emergent grade 3 or 4 laboratory

abnormalities were similar for the three groups. In conclusion, clevudine

showed potent antiviral activity during therapy and induced a sustained

posttreatment antiviral effect for 6 months after a 12-week treatment

period, and this was associated with a sustained normalization of ALT

levels. (HEPATOLOGY 2006;43:982-988.).

PMID: 16628625 [PubMed - as supplied by publisher]

_________________________________________________________________

Don’t just search. Find. Check out the new MSN Search!

http://search.msn.click-url.com/go/onm00200636ave/direct/01/

[Guest guest]

epatology. 2006 Apr 20;43(5):982-988 [Epub ahead of print]

A 12-week clevudine therapy showed potent and durable antiviral activity in

HBeAg-positive chronic hepatitis B.

Lee HS, Chung YH, Lee K, Byun KS, Paik SW, Han JY, Yoo K, Yoo HW, Lee JH,

Yoo BC.

Seoul National University Hospital, Seoul, South Korea.

Clevudine is a nucleoside analog with an unnatural beta-L configuration. In

a phase I/II clinical trial, once daily doses ranging from 10 to 200 mg for

28 days were well tolerated, and produced significant antiviral activity.

The present study was conducted to assess the degree and durability of the

antiviral response to 12 weeks of clevudine treatment, and to investigate

its safety and tolerability. A total of 98 patients with HBeAg-positive

chronic hepatitis B were randomized to placebo (n = 32), 30-mg clevudine (n

= 32), and 50-mg clevudine (n = 34) groups. Patients were followed up after

12 weeks of treatment for a further 24 weeks off-therapy. Median serum

hepatitis B virus DNA reductions from baseline at week 12 were 0.20, 4.49,

and 4.45 log(10) copies/mL in the placebo, 30-mg clevudine, and 50-mg

clevudine groups, respectively (P < .0001). Posttreatment antiviral

activities were sustained, with 3.32 and 2.99 log(10) reductions at week 12

off-therapy and 2.28 and 1.40 log(10) reductions at week 24 off-therapies in

the 30- and 50-mg clevudine groups, respectively. Median serum alanine

aminotransferase (ALT) levels decreased markedly from baseline during

clevudine treatment and were maintained below the upper limit of normal

throughout the 24 weeks off-therapy in the two clevudine-treated groups. The

incidences of adverse events and treatment-emergent grade 3 or 4 laboratory

abnormalities were similar for the three groups. In conclusion, clevudine

showed potent antiviral activity during therapy and induced a sustained

posttreatment antiviral effect for 6 months after a 12-week treatment

period, and this was associated with a sustained normalization of ALT

levels. (HEPATOLOGY 2006;43:982-988.).

PMID: 16628625 [PubMed - as supplied by publisher]

_________________________________________________________________

Don’t just search. Find. Check out the new MSN Search!

http://search.msn.click-url.com/go/onm00200636ave/direct/01/

[Guest guest]

epatology. 2006 Apr 20;43(5):982-988 [Epub ahead of print]

A 12-week clevudine therapy showed potent and durable antiviral activity in

HBeAg-positive chronic hepatitis B.

Lee HS, Chung YH, Lee K, Byun KS, Paik SW, Han JY, Yoo K, Yoo HW, Lee JH,

Yoo BC.

Seoul National University Hospital, Seoul, South Korea.

Clevudine is a nucleoside analog with an unnatural beta-L configuration. In

a phase I/II clinical trial, once daily doses ranging from 10 to 200 mg for

28 days were well tolerated, and produced significant antiviral activity.

The present study was conducted to assess the degree and durability of the

antiviral response to 12 weeks of clevudine treatment, and to investigate

its safety and tolerability. A total of 98 patients with HBeAg-positive

chronic hepatitis B were randomized to placebo (n = 32), 30-mg clevudine (n

= 32), and 50-mg clevudine (n = 34) groups. Patients were followed up after

12 weeks of treatment for a further 24 weeks off-therapy. Median serum

hepatitis B virus DNA reductions from baseline at week 12 were 0.20, 4.49,

and 4.45 log(10) copies/mL in the placebo, 30-mg clevudine, and 50-mg

clevudine groups, respectively (P < .0001). Posttreatment antiviral

activities were sustained, with 3.32 and 2.99 log(10) reductions at week 12

off-therapy and 2.28 and 1.40 log(10) reductions at week 24 off-therapies in

the 30- and 50-mg clevudine groups, respectively. Median serum alanine

aminotransferase (ALT) levels decreased markedly from baseline during

clevudine treatment and were maintained below the upper limit of normal

throughout the 24 weeks off-therapy in the two clevudine-treated groups. The

incidences of adverse events and treatment-emergent grade 3 or 4 laboratory

abnormalities were similar for the three groups. In conclusion, clevudine

showed potent antiviral activity during therapy and induced a sustained

posttreatment antiviral effect for 6 months after a 12-week treatment

period, and this was associated with a sustained normalization of ALT

levels. (HEPATOLOGY 2006;43:982-988.).

PMID: 16628625 [PubMed - as supplied by publisher]

_________________________________________________________________

Don’t just search. Find. Check out the new MSN Search!

http://search.msn.click-url.com/go/onm00200636ave/direct/01/