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Dose Ranging Study of LB 80380 for HBV Infection

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Dose Ranging Study of LB 80380 for HBV Infection

By Mark , MD

LB80380 is a pro drug of LB80331 which is metabolised to LB80317, a

phosphorylated nucleotide analogue of guanosine monophosphate. This

molecule

is further phosphorylated to di- and tri- phosphate forms which inhibit

viral

replication by incorporation into viral DNA.

28 individuals in 4 cohorts are planned to be recruited, and the results of

the first three cohorts dosed at 30mg, 60mg and 120mg were reported at HEP

DART (December 14-18, 2003. Kauai, Hawaii).

The median age was 34 years and the male to female ratio was 15 to 6.

Median

follow up was 19.8 weeks (range 4-30 weeks).

The reduction in HBV DNA was greater in the 60mg and 120mg arms compared to

the 30mg arm, with a maximum HBV DNA reduction of 3 - 4 log.

HBV DNA level returned at a slower rate to pre-treatment levels in the 60mg

arm compared to the 30mg arm. There were no serious adverse events reported

during follow up.

01/12/04

Source

HEP DART 2003. December 14-18, 2003. Kauai, Hawaii

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Dose Ranging Study of LB 80380 for HBV Infection

By Mark , MD

LB80380 is a pro drug of LB80331 which is metabolised to LB80317, a

phosphorylated nucleotide analogue of guanosine monophosphate. This

molecule

is further phosphorylated to di- and tri- phosphate forms which inhibit

viral

replication by incorporation into viral DNA.

28 individuals in 4 cohorts are planned to be recruited, and the results of

the first three cohorts dosed at 30mg, 60mg and 120mg were reported at HEP

DART (December 14-18, 2003. Kauai, Hawaii).

The median age was 34 years and the male to female ratio was 15 to 6.

Median

follow up was 19.8 weeks (range 4-30 weeks).

The reduction in HBV DNA was greater in the 60mg and 120mg arms compared to

the 30mg arm, with a maximum HBV DNA reduction of 3 - 4 log.

HBV DNA level returned at a slower rate to pre-treatment levels in the 60mg

arm compared to the 30mg arm. There were no serious adverse events reported

during follow up.

01/12/04

Source

HEP DART 2003. December 14-18, 2003. Kauai, Hawaii

Link to comment
Share on other sites

Dose Ranging Study of LB 80380 for HBV Infection

By Mark , MD

LB80380 is a pro drug of LB80331 which is metabolised to LB80317, a

phosphorylated nucleotide analogue of guanosine monophosphate. This

molecule

is further phosphorylated to di- and tri- phosphate forms which inhibit

viral

replication by incorporation into viral DNA.

28 individuals in 4 cohorts are planned to be recruited, and the results of

the first three cohorts dosed at 30mg, 60mg and 120mg were reported at HEP

DART (December 14-18, 2003. Kauai, Hawaii).

The median age was 34 years and the male to female ratio was 15 to 6.

Median

follow up was 19.8 weeks (range 4-30 weeks).

The reduction in HBV DNA was greater in the 60mg and 120mg arms compared to

the 30mg arm, with a maximum HBV DNA reduction of 3 - 4 log.

HBV DNA level returned at a slower rate to pre-treatment levels in the 60mg

arm compared to the 30mg arm. There were no serious adverse events reported

during follow up.

01/12/04

Source

HEP DART 2003. December 14-18, 2003. Kauai, Hawaii

Link to comment
Share on other sites

Dose Ranging Study of LB 80380 for HBV Infection

By Mark , MD

LB80380 is a pro drug of LB80331 which is metabolised to LB80317, a

phosphorylated nucleotide analogue of guanosine monophosphate. This

molecule

is further phosphorylated to di- and tri- phosphate forms which inhibit

viral

replication by incorporation into viral DNA.

28 individuals in 4 cohorts are planned to be recruited, and the results of

the first three cohorts dosed at 30mg, 60mg and 120mg were reported at HEP

DART (December 14-18, 2003. Kauai, Hawaii).

The median age was 34 years and the male to female ratio was 15 to 6.

Median

follow up was 19.8 weeks (range 4-30 weeks).

The reduction in HBV DNA was greater in the 60mg and 120mg arms compared to

the 30mg arm, with a maximum HBV DNA reduction of 3 - 4 log.

HBV DNA level returned at a slower rate to pre-treatment levels in the 60mg

arm compared to the 30mg arm. There were no serious adverse events reported

during follow up.

01/12/04

Source

HEP DART 2003. December 14-18, 2003. Kauai, Hawaii

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