Combination Treatment With REP 2139-Ca and Pegasys in Patients With Chronic Hepatitis B
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The REP 201 protocol is a small exploratory study assessing the antiviral effects and
      tolerability of REP 2139-Ca when used with a full course of pegylated interferon (48 weeks)
      in treatment naive patients or in patients already receiving entecavir and continuing
      entecavir with treatment.
    

Detailed description: 
      Chronic hepatitis B is a long term condition caused by infection of the body with the
      hepatitis B virus (HBV). This infection often results in inflammation or scarring of the
      liver and can eventually lead to liver cirrhosis and liver failure. These infections are also
      one of the major causes of the development of hepatocellular carcinoma (liver cancer).

      Although some drugs have been approved to treat chronic hepatitis B infections, they do not
      provide a complete cure except in rare cases (a cure generally means that a person loses the
      hepatitis B virus from the blood and the liver and develops a durable immunological control
      of subsequent HBV infection). However, these drugs do significantly decrease the risk of
      liver damage and liver cancer arising from the presence of a chronic liver infection by
      slowing or stopping the production of infectious virus. Thus the primary problem associated
      with currently available drugs is the lack of clearance of the virus from the hepatocytes
      which necessitates long term treatment with these drugs. There is clearly a need to identify
      new drugs that can benefit patients with chronic hepatitis B infections. Nucleic acid-based
      polymers (NAPs) are a new class of broad-spectrum antiviral compounds which act against HBV
      infection by blocking the release of the surface antigen protein (HBsAg) from infected
      hepatocytes.

      Current interim data analysis from the REP 102 assessing the activity of the NAP REP 9AC'
      (REP 2139, given as a calcium chelate complex [REP 2139-Ca]) in patients with chronic HBV
      infection indicates the following:

        1. REP 2139-Ca is generally well tolerated and patients tolerate short term combined
           treatment (13-26 weeks) of pegylated interferon and / or thymosin alpha

        2. REP 2139-Ca has achieved serum HBsAg reduction or clearance 9 of 9 patients receiving
           combined therapy.

        3. Appearance of substantial titers of serum anti-HBs occur with the addition of
           immunotherapy.

        4. After all treatment is withdrawn, 8 / 9 patients achieved HBV DNA < 116 copies / ml
           (LLOQ of the Roche Cobas platform) and sustained suppression of viremia (HBV DNA < 1000
           cpm, HBsAg < 1 IU / ml) for a period of greater than 1 year was observed in four
           patients.

      This exploratory study is designed to examine if REP 2139-Ca can be safely combined with a
      full course of pegylated interferon in treatment naive patients and in patients with previous
      and continuing therapy with entecavir and that similar antiviral effects can be observed as
      in the previous REP 101 and 102 protocols.
    

Intervention name(s): REP 2139-Ca; pegylated interferon; entecavir
Intervention type(s): Drug; Drug; Drug
Intervention description(s): the nucleic acid polymer REP 2139 formulated as a calcium chelate complex; immunotherapy; local generic entecavir
Other intervention name(s): pegylated interferon alpha 2a, Pegasys(R); local generic entecavir
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a; Entecavir; REP 2139
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: nucleic acid polymer REP 2139 HBsAg hepatitis B