Adding Alisporivir to Standard Treatment Results in Sustained Virologic Response in Patients With Chronic HCV

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Source: DGNews | Posted 14 hours ago

Adding Alisporivir to Standard Treatment Results in Sustained Virologic Response

in Patients With Chronic HCV: Presented at EASL

By Berrie

BERLIN -- April 3, 2011 -- Addition of daily alisporivir to ribavirin and

pegylated interferon alpha-2a (rbv/PegIFN) is well tolerated and provides

superior efficacy over rbv/PegIFN alone in treatment-naïve patients with

chronic hepatitis C virus (HCV) genotype 1, researchers said here at the 46th

Annual Meeting of the European Association of the Study of the Liver (EASL).

“Alisporivir is a host-targeting antiviral, and, as a cyclophilin inhibitor,

it targets proteins, which are essential for viral replication,†explained

Flisiak, MD, Department of Infectious Diseases and Hepatology, Medical

University Bialystok, Bialystok, Poland, on March 31. It also has potent

activity across all HCV genotypes, he added.

The researchers compared treatment with rbv/PegIFN (n = 73) with alisporivir

plus rbv/PegIFN for 24 weeks (n = 72), 48 weeks (n = 72), or 24 weeks in

response-guided treatment (RGT), which was done according to rapid virological

response (n = 71) among treatment-naïve patients with chronic HCV.

The primary endpoint was sustained virological response (SVR) at 48 weeks.

At 48 weeks, SVR was 55% in the rbv/PegIFN alone group, 53% in the alisporivir

24-weeks group, 76% in the alisporivir 48-weeks group, and 69% in the

alisporivir RGT group.

When patients were divided according to IL28B genotype, across almost all

alisporivir treatments, SVR at 70-week follow-up was increased irrespective of

IL28B CC or TT genotype.

In the alisporivir 48-week group and the alisporivir RGT group, achieving rapid

virological response was 100% predictive of SVR at week 24.

Viral breakthrough (HCV RNA increase >1 log10 IU/mL from nadir during treatment)

was reached by 5.5% of patients in the rbv/PegIFN-alone group, compared with

4.7% for the combined alisporivir arms.

“If we take only the patients on full dose of alisporivir, at the time of

viral breakthrough, the rate [of 2.8%] was half of the standard-of-care arm,â€

said Dr. Flisiak.

Finally, patient relapse rates during post-treatment follow-up was 23.5% for

patients in the rbv/PegIFN-alone group, 38.5% in the alisporivir 24-week group,

15.3% in the alisporivir 48-week group, and 16.4% in the alisporivir RGT group.

Rates of serious adverse events (AEs) were similar across treatment groups, with

low, similar rates of discontinuation due to AEs. The most common AEs were

asthma, headache, nausea, and hyperbilirubinaemia. However, hyperbilirubinaemia

was only associated with alisporivir loading and the patients (4.2%) with total

bilirubin levels ≥5 times the upper limit of normal were all resolved by week

4. ôRapid [alanine transaminase] normalisation was seen only in the alisporivir

arms, " added Dr. Flisiak.

[Presentation title: Once Daily Alisporivir (DEB025) Plus PegIFNalfa2a/Ribavirin

Results in Superior Sustained Virological Response (SVR24) in Chronic Hepatitis

C Genotype 1 Treatment-Naïve Patients. Abstract 4]

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http://www.docguide.com/adding-alisporivir-standard-treatment-results-sustained-\

virologic-response-patients-chronic-hcv?hash=04301bd4 & eid=19214 & alrhash=2e06a4-d\

460252966da8019c5213f6ae197892e

Source: DGNews | Posted 14 hours ago

Adding Alisporivir to Standard Treatment Results in Sustained Virologic Response

in Patients With Chronic HCV: Presented at EASL

By Berrie

BERLIN -- April 3, 2011 -- Addition of daily alisporivir to ribavirin and

pegylated interferon alpha-2a (rbv/PegIFN) is well tolerated and provides

superior efficacy over rbv/PegIFN alone in treatment-naïve patients with

chronic hepatitis C virus (HCV) genotype 1, researchers said here at the 46th

Annual Meeting of the European Association of the Study of the Liver (EASL).

“Alisporivir is a host-targeting antiviral, and, as a cyclophilin inhibitor,

it targets proteins, which are essential for viral replication,†explained

Flisiak, MD, Department of Infectious Diseases and Hepatology, Medical

University Bialystok, Bialystok, Poland, on March 31. It also has potent

activity across all HCV genotypes, he added.

The researchers compared treatment with rbv/PegIFN (n = 73) with alisporivir

plus rbv/PegIFN for 24 weeks (n = 72), 48 weeks (n = 72), or 24 weeks in

response-guided treatment (RGT), which was done according to rapid virological

response (n = 71) among treatment-naïve patients with chronic HCV.

The primary endpoint was sustained virological response (SVR) at 48 weeks.

At 48 weeks, SVR was 55% in the rbv/PegIFN alone group, 53% in the alisporivir

24-weeks group, 76% in the alisporivir 48-weeks group, and 69% in the

alisporivir RGT group.

When patients were divided according to IL28B genotype, across almost all

alisporivir treatments, SVR at 70-week follow-up was increased irrespective of

IL28B CC or TT genotype.

In the alisporivir 48-week group and the alisporivir RGT group, achieving rapid

virological response was 100% predictive of SVR at week 24.

Viral breakthrough (HCV RNA increase >1 log10 IU/mL from nadir during treatment)

was reached by 5.5% of patients in the rbv/PegIFN-alone group, compared with

4.7% for the combined alisporivir arms.

“If we take only the patients on full dose of alisporivir, at the time of

viral breakthrough, the rate [of 2.8%] was half of the standard-of-care arm,â€

said Dr. Flisiak.

Finally, patient relapse rates during post-treatment follow-up was 23.5% for

patients in the rbv/PegIFN-alone group, 38.5% in the alisporivir 24-week group,

15.3% in the alisporivir 48-week group, and 16.4% in the alisporivir RGT group.

Rates of serious adverse events (AEs) were similar across treatment groups, with

low, similar rates of discontinuation due to AEs. The most common AEs were

asthma, headache, nausea, and hyperbilirubinaemia. However, hyperbilirubinaemia

was only associated with alisporivir loading and the patients (4.2%) with total

bilirubin levels ≥5 times the upper limit of normal were all resolved by week

4. ôRapid [alanine transaminase] normalisation was seen only in the alisporivir

arms, " added Dr. Flisiak.

[Presentation title: Once Daily Alisporivir (DEB025) Plus PegIFNalfa2a/Ribavirin

Results in Superior Sustained Virological Response (SVR24) in Chronic Hepatitis

C Genotype 1 Treatment-Naïve Patients. Abstract 4]

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http://www.docguide.com/adding-alisporivir-standard-treatment-results-sustained-\

virologic-response-patients-chronic-hcv?hash=04301bd4 & eid=19214 & alrhash=2e06a4-d\

460252966da8019c5213f6ae197892e

Source: DGNews | Posted 14 hours ago

Adding Alisporivir to Standard Treatment Results in Sustained Virologic Response

in Patients With Chronic HCV: Presented at EASL

By Berrie

BERLIN -- April 3, 2011 -- Addition of daily alisporivir to ribavirin and

pegylated interferon alpha-2a (rbv/PegIFN) is well tolerated and provides

superior efficacy over rbv/PegIFN alone in treatment-naïve patients with

chronic hepatitis C virus (HCV) genotype 1, researchers said here at the 46th

Annual Meeting of the European Association of the Study of the Liver (EASL).

“Alisporivir is a host-targeting antiviral, and, as a cyclophilin inhibitor,

it targets proteins, which are essential for viral replication,†explained

Flisiak, MD, Department of Infectious Diseases and Hepatology, Medical

University Bialystok, Bialystok, Poland, on March 31. It also has potent

activity across all HCV genotypes, he added.

The researchers compared treatment with rbv/PegIFN (n = 73) with alisporivir

plus rbv/PegIFN for 24 weeks (n = 72), 48 weeks (n = 72), or 24 weeks in

response-guided treatment (RGT), which was done according to rapid virological

response (n = 71) among treatment-naïve patients with chronic HCV.

The primary endpoint was sustained virological response (SVR) at 48 weeks.

At 48 weeks, SVR was 55% in the rbv/PegIFN alone group, 53% in the alisporivir

24-weeks group, 76% in the alisporivir 48-weeks group, and 69% in the

alisporivir RGT group.

When patients were divided according to IL28B genotype, across almost all

alisporivir treatments, SVR at 70-week follow-up was increased irrespective of

IL28B CC or TT genotype.

In the alisporivir 48-week group and the alisporivir RGT group, achieving rapid

virological response was 100% predictive of SVR at week 24.

Viral breakthrough (HCV RNA increase >1 log10 IU/mL from nadir during treatment)

was reached by 5.5% of patients in the rbv/PegIFN-alone group, compared with

4.7% for the combined alisporivir arms.

“If we take only the patients on full dose of alisporivir, at the time of

viral breakthrough, the rate [of 2.8%] was half of the standard-of-care arm,â€

said Dr. Flisiak.

Finally, patient relapse rates during post-treatment follow-up was 23.5% for

patients in the rbv/PegIFN-alone group, 38.5% in the alisporivir 24-week group,

15.3% in the alisporivir 48-week group, and 16.4% in the alisporivir RGT group.

Rates of serious adverse events (AEs) were similar across treatment groups, with

low, similar rates of discontinuation due to AEs. The most common AEs were

asthma, headache, nausea, and hyperbilirubinaemia. However, hyperbilirubinaemia

was only associated with alisporivir loading and the patients (4.2%) with total

bilirubin levels ≥5 times the upper limit of normal were all resolved by week

4. ôRapid [alanine transaminase] normalisation was seen only in the alisporivir

arms, " added Dr. Flisiak.

[Presentation title: Once Daily Alisporivir (DEB025) Plus PegIFNalfa2a/Ribavirin

Results in Superior Sustained Virological Response (SVR24) in Chronic Hepatitis

C Genotype 1 Treatment-Naïve Patients. Abstract 4]

[Guest guest]

http://www.docguide.com/adding-alisporivir-standard-treatment-results-sustained-\

virologic-response-patients-chronic-hcv?hash=04301bd4 & eid=19214 & alrhash=2e06a4-d\

460252966da8019c5213f6ae197892e

Source: DGNews | Posted 14 hours ago

Adding Alisporivir to Standard Treatment Results in Sustained Virologic Response

in Patients With Chronic HCV: Presented at EASL

By Berrie

BERLIN -- April 3, 2011 -- Addition of daily alisporivir to ribavirin and

pegylated interferon alpha-2a (rbv/PegIFN) is well tolerated and provides

superior efficacy over rbv/PegIFN alone in treatment-naïve patients with

chronic hepatitis C virus (HCV) genotype 1, researchers said here at the 46th

Annual Meeting of the European Association of the Study of the Liver (EASL).

“Alisporivir is a host-targeting antiviral, and, as a cyclophilin inhibitor,

it targets proteins, which are essential for viral replication,†explained

Flisiak, MD, Department of Infectious Diseases and Hepatology, Medical

University Bialystok, Bialystok, Poland, on March 31. It also has potent

activity across all HCV genotypes, he added.

The researchers compared treatment with rbv/PegIFN (n = 73) with alisporivir

plus rbv/PegIFN for 24 weeks (n = 72), 48 weeks (n = 72), or 24 weeks in

response-guided treatment (RGT), which was done according to rapid virological

response (n = 71) among treatment-naïve patients with chronic HCV.

The primary endpoint was sustained virological response (SVR) at 48 weeks.

At 48 weeks, SVR was 55% in the rbv/PegIFN alone group, 53% in the alisporivir

24-weeks group, 76% in the alisporivir 48-weeks group, and 69% in the

alisporivir RGT group.

When patients were divided according to IL28B genotype, across almost all

alisporivir treatments, SVR at 70-week follow-up was increased irrespective of

IL28B CC or TT genotype.

In the alisporivir 48-week group and the alisporivir RGT group, achieving rapid

virological response was 100% predictive of SVR at week 24.

Viral breakthrough (HCV RNA increase >1 log10 IU/mL from nadir during treatment)

was reached by 5.5% of patients in the rbv/PegIFN-alone group, compared with

4.7% for the combined alisporivir arms.

“If we take only the patients on full dose of alisporivir, at the time of

viral breakthrough, the rate [of 2.8%] was half of the standard-of-care arm,â€

said Dr. Flisiak.

Finally, patient relapse rates during post-treatment follow-up was 23.5% for

patients in the rbv/PegIFN-alone group, 38.5% in the alisporivir 24-week group,

15.3% in the alisporivir 48-week group, and 16.4% in the alisporivir RGT group.

Rates of serious adverse events (AEs) were similar across treatment groups, with

low, similar rates of discontinuation due to AEs. The most common AEs were

asthma, headache, nausea, and hyperbilirubinaemia. However, hyperbilirubinaemia

was only associated with alisporivir loading and the patients (4.2%) with total

bilirubin levels ≥5 times the upper limit of normal were all resolved by week

4. ôRapid [alanine transaminase] normalisation was seen only in the alisporivir

arms, " added Dr. Flisiak.

[Presentation title: Once Daily Alisporivir (DEB025) Plus PegIFNalfa2a/Ribavirin

Results in Superior Sustained Virological Response (SVR24) in Chronic Hepatitis

C Genotype 1 Treatment-Naïve Patients. Abstract 4]