( nts who discontinuedstudy therapy in E...)Baraclude (entecavir) Therapy Resulted in Undetectable Levels of,Hepatitis B Virus in Cohort of Patients Who Re-Started Treatment,Health

    -- ETV-027 compared 0.5 mg of BARACLUDE vs. 100 mg of lamivudine in
nucleoside-naive chronic HBeAg-negative chronic hepatitis B patients.
-- Rollover study ETV-901 was established as an open-label, follow-up
protocol for patients in phase II and III studies of BARACLUDE.
-- Due to ongoing blinding of study ETV-027, most patients retreated in
ETV-901 initially received a combination of 1 mg of BARACLUDE plus 100
mg of lamivudine, and were subsequently switched to 1 mg of BARACLUDE
monotherapy.

The analysis cohort was defined regardless of treatment response at the end of dosing in study ETV-027, and independent of virologic or ALT measurements at the start of dosing in study ETV-901. During off-treatment follow-up, the majority of patients had recurrent levels of hepatitis B virus in the blood (viremia) and increases in ALT.

    Data Results
At the end of dosing for study ETV-027:
-- 94 percent (n=93/99) of the re-treatment cohort had undetectable viral
load
-- 78 percent (n=77/99) had ALT normalization
At entry into ETV-901:
-- Four percent (n=4/99) of patients had undetectable viral load
-- Eight percent (n=8/97) of patients had ALT normalization
Following re-treatment in study ETV-901:
-- 93 percent (n=82/88) of patients had undetectable viral load (HBV DNA
<300 copies/mL) by week 48 of re-treatment with BARACLUDE
-- 83 percent (n=79/95) of patients had ALT normalization (ALT less than
or equal to 1 times the upper limit of normal) by week 48 of re-
treatment BARACLUDE
Adverse events in study ETV-027/901 re-treatment cohort:
-- 67 percent (n=66/99) of patients experienced an adverse event. The most
common adverse events occurring in greater than ten percent of patients
were abdominal pain, fa
'"/>




Page: 1 2 3 4 5 
Related medicine technology :

1. Baraclude (Entecavir) Treatment Demonstrated Greater Viral Load
Reduction Compared to Adefovir at 48 Weeks in Study of
Antiviral-Naive Chronic Hepatitis B E-Antigen Positive Patients
2. Gene Chips to Detect CYP Variations: A New Step Toward Customized Medical Therapy.
3. Breast Cancer and HER-2/neu: Diagnostic Tools for Targeted Therapy
4. Pixantrone Combination Therapy for First-line Treatment of
Aggressive Non-Hodgkins Lymphoma Results in Reduction in Severe
Toxicities Including Heart Damage When Compared to
Doxorubicin-based Therapy
5. Gene Therapy Eradicates Pancreatic Cancer in Preclinical Trial
Targeting Systems Success in Mouse Model Reported in Cancer Cell
6. Response Genetics Announces Publication of a Phase III Clinical
Trial Demonstrating That Low Levels of ERCC-1 Help to Predict
Likelihood of Response to Cisplatin-Based Therapy in Lung Cancer
7. New Phase 3 Study Published in The Lancet Evaluates Efficacy and
Safety of Prezista/Ritonavir vs. Kaletra as Part of HIV Combination
Therapy in Treatment-Experienced Adults With HIV
8. Lexicon Develops Antibodies That Lower Triglycerides and
Cholesterol as Potential New Therapy for Heart Disease
9. Studies of Drug Resistance May Lead to Individual Therapy for Rare
Cancers
10. Velcade (bortezomib) for Injection Based Induction Therapy
Delivered High Post-Transplant Complete Remission Rate, a Critical
Marker for Increased Overall Survival
11. A 4-Week Therapy with Transition Therapeutics E1-I.N.T. Leads to
Sustained Reductions in Blood Glucose Levels for 6 Months
Post-treatment in Type 2 Diabetes Patients