Hepatitis B Virus (HBV) Viral Suppression by Entecavir in Adefovir Partial Responders

Condition(s) targeted: Hepatitis B

Intervention: Entecavir (Drug); Entecavir (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Pacific Health Foundation

Official(s) and/or principal investigator(s):
Huy N Trinh, M.D., Principal Investigator, Affiliation: Pacific Health Foundation
Mindie H Nguyen, M.D., M.A.S., Principal Investigator, Affiliation: Pacific Health Foundation

Overall contact:
Long H Nguyen, B.A., Phone: 408-995-0333, Email: longnguyen07@gmail.com

We propose a largely retrospective study with short-term prospective follow-up in a subgroup of patients who have not yet been treated with 48 weeks of entecavir following partial response to adefovir. The aim of the study is to describe sequential virologic response to adefovir and entecavir.

Official title: HBV Viral Suppression by Entecavir in Adefovir Partial Responders

Study design: Cohort, Other

Primary outcome: Our goal is to study patients with chronic hepatitis B, who have been switched to entecavir due to suboptimal treatment response with adefovir for a minimum of 12 weeks with < 2 log drop IU/mL or with persistent viremia after 48 weeks.

Secondary outcome:

Compare rate of complete response (CR) as measured by complete virologic and biochemical response at 24 and 48 weeks in patients who had been treated with adefovir for 24 and 48 weeks prior to switching.

Compare rates of biochemical response (BR) as measured by ALT normalization on the 2 different treatments at corresponding treatment milestones as above.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Age 18 years or older

- All genders and ethnicity

- Positive HBsAg

- HBeAg positive and negative

- Pretreatment HBV DNA of 10,000 copies/mL or higher (for purposes of this study, both

copies and equivalent IU measurements will be recorded and analyzed)

- Patients who are switched to entecavir after treatment with adefovir for at least 12

weeks by the providing physician.

- Less than a 2 log drop in HBV DNA from baseline at week 12.

- Patient already on adefovir for 24 weeks and still have > or equal to 1000 copies/mL

of HBV DNA.

- Patients who still have positive HBV DNA PCR after 48 weeks or longer of adefovir.

Exclusion Criteria:

- Patients who refused to consent to the study

- Patients younger than 18

- Vulnerable subjects such as pregnant women, prisoners, employees, patients with

significant cognitive deficits.

- Patients with prior exposure to another nucleoside for more than 2 weeks.

- HIV co-infection

- HCV co-infection

- HDV co-infection

- Recipients of solid organ transplantation

- Patients who receive high-dose steroid (60 mg/d or higher and for longer than 10

days)

Long H Nguyen, B.A., Phone: 408-995-0333, Email: longnguyen07@gmail.com

San Jose Gastroenterology, San Jose, California 95116, United States; Recruiting
Long H Nguyen, B.A., Phone: 408-995-0333, Email: longnguyen07@gmail.com
Huy N Trinh, M.D., Principal Investigator

San Jose Gastroenterology, San Jose, California 95128, United States; Recruiting
Long H Nguyen, B.A., Phone: 408-995-0333, Email: longnguyen07@gmail.com
Huy N Trinh, M.D., Principal Investigator

Digestive Health Associates of Texas, Plano, Texas 75093, United States; Recruiting
Son Do, M.D., Phone: 972-398-0393, Email: dotuongson@yahoo.com
Son Do, M.D., Principal Investigator

Houston Gastroenterology Clinic, Houston, Texas 77072, United States; Recruiting
Thuan Nguyen, M.D., Phone: 281-983-0938, Email: giassoc@ev1.net
Thuan Nguyen, M.D., Principal Investigator

Related publications:

McMahon BJ. Epidemiology and natural history of hepatitis B. Semin Liver Dis. 2005;25 Suppl 1:3-8. Review.

Chen CJ, Yang HI, Su J, Jen CL, You SL, Lu SN, Huang GT, Iloeje UH; REVEAL-HBV Study Group. Risk of hepatocellular carcinoma across a biological gradient of serum hepatitis B virus DNA level. JAMA. 2006 Jan 4;295(1):65-73.

Iloeje UH, Yang HI, Su J, Jen CL, You SL, Chen CJ; Risk Evaluation of Viral Load Elevation and Associated Liver Disease/Cancer-In HBV (the REVEAL-HBV) Study Group. Predicting cirrhosis risk based on the level of circulating hepatitis B viral load. Gastroenterology. 2006 Mar;130(3):678-86.

Liaw YF, Sung JJ, Chow WC, Farrell G, Lee CZ, Yuen H, Tanwandee T, Tao QM, Shue K, Keene ON, Dixon JS, Gray DF, Sabbat J; Cirrhosis Asian Lamivudine Multicentre Study Group. Lamivudine for patients with chronic hepatitis B and advanced liver disease. N Engl J Med. 2004 Oct 7;351(15):1521-31.

Lok AS, McMahon BJ. Chronic hepatitis B. Hepatology. 2007 Feb;45(2):507-39. No abstract available. Erratum in: Hepatology. 2007 Jun;45(6):1347.

Keeffe EB, Dieterich DT, Han SH, Jacobson IM, Martin P, Schiff ER, Tobias H, Wright TL. A treatment algorithm for the management of chronic hepatitis B virus infection in the United States: an update. Clin Gastroenterol Hepatol. 2006 Aug;4(8):936-62. Epub 2006 Jul 14. Review.

Shaw T, Locarnini S. Entecavir for the treatment of chronic hepatitis B. Expert Rev Anti Infect Ther. 2004 Dec;2(6):853-71. Review.

Chan HL, Heathcote EJ, Marcellin P, Lai CL, Cho M, Moon YM, Chao YC, Myers RP, Minuk GY, Jeffers L, Sievert W, Bzowej N, Harb G, Kaiser R, Qiao XJ, Brown NA; 018 Study Group. Treatment of hepatitis B e antigen positive chronic hepatitis with telbivudine or adefovir: a randomized trial. Ann Intern Med. 2007 Dec 4;147(11):745-54. Epub 2007 Oct 1.

Keeffe EB, Zeuzem S, Koff RS, Dieterich DT, Esteban-Mur R, Gane EJ, Jacobson IM, Lim SG, Naoumov N, Marcellin P, Piratvisuth T, Zoulim F. Report of an international workshop: Roadmap for management of patients receiving oral therapy for chronic hepatitis B. Clin Gastroenterol Hepatol. 2007 Aug;5(8):890-7. Epub 2007 Jul 13. Review.

Starting date: May 2008
Ending date: January 2009
Last updated: June 23, 2008