Virologic Response To Pegasys With Genotype 4 in Small Study Group

[Guest guest]

Virologic Response To Pegasys With Genotype 4 in Small

Study Group

Sherman from Toronto General Hospital reported

at I think AASLD

November 2000 response to Pegasys and regular

Interferon a-2a for

individuals

with chronic HCV and genotype 4.

It has been reported that treatment with standard IFN

is less effective

in

patients with genotypes 1 and 4 than in patients with

genotypes 2 and

3. The

purpose of this retrospective analysis was to compare

the effectiveness

of

Pegasys (40 kDa) IFN a-2a once weekly with IFN a-2a

taken 3 times

weekly in

patients chronically infected with hepatitis C with

the difficult to

treat

genotype 4. The investigators looked at a database

consisting of 1208

patients from large randomized phase II and III

studies comparing three

times

weekly injections of IFN a-2a (3 MIU or 6 MIU) to

treatment with once

weekly

Pegasys IFN a-2a (180 ug). Effectiveness was evaluated

in a subset of

patients infected with genotype 4.

Sixteen patients were found to have genotype 4. Five

patients received

treatment with IFN a-2a three times weekly and 11 were

treated with 180

ug

Pegasys IFN a-2a once weekly for up to 48 weeks.

Patients were

predominantly

male (63%), with baseline viral loads ranging from

8,000 to >12 million

copies/ml (COBAS Amplicor Monitor HCV, version 2.0).

Four patients

(25%) had

cirrhosis. End-of-treatment (week 48) virologic

responses (COBAS

Amplicor HCV

Test version 2.0 with lower limit of detection of 100

copies/ml) were

0% in

the standard IFN a-2a patients and 73% in the Pegasys

group. Sustained

virologic response (week 72) was obtained on 0% of

patients receiving

standard IFN and 45% in Pegasys treated patients. All

patients that

were

sustained virologic responders were also sustained

biochemical

responders.

Paired biopsies (pre and post treatment) were obtained

for 8 patients

treated

with Pegasys and histologic response (improved liver

condition)

measured by a

>2 point decrease in Histology Activity Index (HAI)

was found in 5 of

these

patients (63%). Histologic response was observed in

2/3 patiented with

paired

biopsies and treated with standard IFN.

The authors concluded that the number of patients with

genotype 4 found

to

respond well to Pegasys was small, but the data are

encoraging and

indicate

that further larger studies should be conducted in

genotype 4 patients.

__________________________________________________

[Guest guest]

Virologic Response To Pegasys With Genotype 4 in Small

Study Group

Sherman from Toronto General Hospital reported

at I think AASLD

November 2000 response to Pegasys and regular

Interferon a-2a for

individuals

with chronic HCV and genotype 4.

It has been reported that treatment with standard IFN

is less effective

in

patients with genotypes 1 and 4 than in patients with

genotypes 2 and

3. The

purpose of this retrospective analysis was to compare

the effectiveness

of

Pegasys (40 kDa) IFN a-2a once weekly with IFN a-2a

taken 3 times

weekly in

patients chronically infected with hepatitis C with

the difficult to

treat

genotype 4. The investigators looked at a database

consisting of 1208

patients from large randomized phase II and III

studies comparing three

times

weekly injections of IFN a-2a (3 MIU or 6 MIU) to

treatment with once

weekly

Pegasys IFN a-2a (180 ug). Effectiveness was evaluated

in a subset of

patients infected with genotype 4.

Sixteen patients were found to have genotype 4. Five

patients received

treatment with IFN a-2a three times weekly and 11 were

treated with 180

ug

Pegasys IFN a-2a once weekly for up to 48 weeks.

Patients were

predominantly

male (63%), with baseline viral loads ranging from

8,000 to >12 million

copies/ml (COBAS Amplicor Monitor HCV, version 2.0).

Four patients

(25%) had

cirrhosis. End-of-treatment (week 48) virologic

responses (COBAS

Amplicor HCV

Test version 2.0 with lower limit of detection of 100

copies/ml) were

0% in

the standard IFN a-2a patients and 73% in the Pegasys

group. Sustained

virologic response (week 72) was obtained on 0% of

patients receiving

standard IFN and 45% in Pegasys treated patients. All

patients that

were

sustained virologic responders were also sustained

biochemical

responders.

Paired biopsies (pre and post treatment) were obtained

for 8 patients

treated

with Pegasys and histologic response (improved liver

condition)

measured by a

>2 point decrease in Histology Activity Index (HAI)

was found in 5 of

these

patients (63%). Histologic response was observed in

2/3 patiented with

paired

biopsies and treated with standard IFN.

The authors concluded that the number of patients with

genotype 4 found

to

respond well to Pegasys was small, but the data are

encoraging and

indicate

that further larger studies should be conducted in

genotype 4 patients.

__________________________________________________