Hepatitis B

Medication adherence and antiviral resistance in patients receiving oral antiviral therapy for chronic hepatitis B

Enrollment status: Actively enrolling

Objective

To study rate of antiviral drug resistance and to characterize patterns of drug resistance mutations in hepatitis B patients receiving nucleos(t)ide analogues in clinical practice.

Inclusion/exclusion criteria

  • Adults receiving nucleos(t)ide analogues for chronic hepatitis B

Principal investigator: Anna Lok, MD aslok@med.umich.edu

Contact person: Sravanthi Kaza (734) 615-3853 or sravanth@med.umich.edu

Long-term safety and efficacy of tenofovir in patients with chronic hepatitis B

Enrollment status: Study is ongoing but enrollment is closed. Patients will be followed for a total of 8 years.

NIH Hepatitis B Research Network

In September 2008, the NIH launched a Hepatitis B Research Network (http://www.hepbnet.org) comprised of 29 clinical centers (adult and pediatric), a data coordinating center, and an immunology laboratory. The University of Michigan is one of the clinical centers and Dr. Anna Lok is the chair of the steering committee of this network.

This network will conduct observational studies as well as clinical studies of new treatment strategies.

Hepatitis B Research Network – Observational Study

Enrollment status: Actively enrolling

Objective

To study the pattern of hepatitis B in North America and the rates of transition through different phases of chronic HBV infection.

Inclusion/exclusion criteria

  • Adult patients with hepatitis B who are currently not on any antiviral therapy for hepatitis B (exception: pregnant women).

Principal investigator: Anna Lok, MD aslok@med.umich.edu

Contact person: Sravanthi Kaza: (734) 615-3853 or sravanth@med.umich.edu

Hepatitis B Research Network – Immune-Tolerant Trial

Combination entecavir and peginterferon alfa-2a therapy in hepatitis B e antigen (HBeAg)–positive immune-tolerant adults with chronic hepatitis B

Enrollment status: Actively enrolling

Objective

To determine the efficacy of treatment with 8 weeks of entecavir followed by 40 weeks of both entecavir and peginterferon alfa-2a in HBeAg-positive adults who are in the immune-tolerant phase.

Inclusion/exclusion criteria

  • Adults with chronic hepatitis B infection, HBeAg-positive, normal to slightly abnormal liver enzyme levels, no previous antiviral treatment.

Study design

Randomized controlled trial comparing treatment (8 weeks entecavir followed by 40 weeks of both entecavir and peginterferon alfa-2a) and no treatment.

Principal investigator: Anna Lok, MD aslok@med.umich.edu

Contact person: Sravanthi Kaza: (734) 615-3853 or sravanth@med.umich.edu

Hepatitis B Research Network – Immune-Active Trial

Combination therapy of peginterferon alfa-2a and tenofovir versus tenofovir monotherapy in HBeAg-positive and HBeAg-negative chronic hepatitis B

Enrollment status: Actively enrolling

Objective

To compare the long-term efficacy of initial treatment with combination therapy consisting of peginterferon alfa-2a plus tenofovir DF versus tenofovir DF monotherapy.

Inclusion/exclusion criteria

  • Adults with chronic hepatitis B infection, slightly abnormal liver enzyme levels (ALT >60 IU/mL for males and >40 IU/mL for females), no or limited previous antiviral treatment.
  • Patients with cirrhosis can be included provided no liver failure
  • Normal kidney function, no major medical or psychosocial illnesses, can tolerate interferon

Study design

This is a randomized (1:1) trial comparing

  1. Tenofovir DF 300 mg daily for 192 weeks (4 years) with

  2. Peginterferon alfa-2a 180 μg weekly for 24 weeks plus tenofovir DF 300 mg daily for 192 weeks (4 years).

Note: The cost of medications, clinical evaluations, and tests associated with the study will be covered.

Principal investigator: Anna Lok, MD aslok@med.umich.edu

Contact person: Sravanthi Kaza: (734) 615-3853 or sravanth@med.umich.edu