Hepatitis - Highlights

Highlights

Drug Approvals

• In 2005, the FDA approved entecavir (Baraclude) for treatment of adults with chronic hepatitis B. In clinical trials, entecavir worked better than lamivudine. However, questions have been raised about the drug?s possible cancer risks.

Drug Warnings

• In 2004, the FDA issued two drug warnings for patients with hepatitis B (HBV). The HIV drug tenofovir (Viread) should not be used to treat patients who also have HBV as the drug may increase hepatitis severity. The lymphoma drug rituximab (Rituxan) may reactivate HBV.

Investigative Drugs for Hepatitis B

• Pegylated interferon alfa-2b (Peg-Intron) is being investigated alone and in combination with lamivudine for treatment of HBV. One 2005 study found that a third of patients treated solely with pegylated interferon-alfa-2b became negative for the hepatitis B antigen. Combining the drug with lamivudine did not improve effectiveness. Another 2005 trial found that combination pegylated interferon alfa-2b and lamivudine produced better response and less drug resistance than lamivudine single therapy.

Investigative Drugs for Hepatitis C

• Several new nucleoside analogs are in clinical development. In Phase III trials, viramidine is being tested alone and in combination with pegylated interferon-alfa. In Phase II trials, valopicitabine (NM283) is being studied alone and in combination with pegylated interferons.
• Albuferon. This long-acting form of interferon-alfa may have fewer side effects and require less dosing than pegylated interferons. It is in Phase II trials for patients who have not been treated with or have not responded to standard interferon-alfa.

Research

Liver cancer. According to a 2005 study, interferon therapy can help patients with hepatitis C-induced cirrhosis reduce the risk of developing liver cancer.

Liver transplantation. A 2004 study found that the hepatitis C virus recurs with more severity with liver donations from living donors than livers taken from cadavers.