Regulatory

REFILE: Baraclude treatment of HBV may induce HIV resistance

Last Updated: 2007-03-07 16:29:05 -0400 (Reuters Health)

[Refile of item 20070301rglt001, originally posted on March 1, 2007, for clients who may have received a truncated version.]

NEW YORK (Reuters Health) - The US Food and Drug Administration has placed a warning on its MedWatch web site regarding a case report in which HIV developed a drug resistance mutation after the patient involved began treatment with entecavir (Baraclude) for co-infection with hepatitis B virus (HBV).

Bristol-Myers Squibb notified health care providers of this case and the company's change in recommendations. Its current treatment guidelines recommend entecavir as an option for the treatment of chronic HBV infection in individuals co-infected with HIV who are ineligible for HAART.

The company reports that the 31-year-old male discontinued treatment with antiretroviral agents in the year 2000. In early 2006, entecavir was prescribed for treatment of HBV. Prior to starting the drug, the patient's HIV-1 RNA level was 35,000 copies/mL, with no evidence of drug resistance.

Within 2 months, his HBV DNA decreased by approximately 5.5 log-10 IU/mL, and the HIV-1 RNA decreased to roughly 2,000 copies/mL. However, 6 months after initiating treatment with entecavir, HIV resistance testing revealed a M184V substitution.

As a result of this case, Bristol-Myers Squibb is changing its package insert.

Under section MICROBIOLOGY/Antiviral Activity, the company is adding the statement, "The EC50 value of entecavir against human immunodeficiency virus (HIV) type 1 laboratory strains NL4-3, BRU and LAI was > 1 micromolar in cell culture assays."

And under section INDICATIONS AND USAGE/Description of Clinical Studies/Special Populations, the instructions will read, "BARACLUDE has not been evaluated in HIV/HBV co-infected patients who were not simultaneously receiving effective HIV treatment."

In their letter, the company advises caution if Baraclude is used in HIV/HBV co-infected patients who are not being treated with HAART.

To obtain further information from Bristol-Myers Squibb regarding the appropriate use of entecavir or to report entecavir-related adverse events, providers can call 1-800-321-1335 or view the revised package insert online at www.baraclude.com.

Healthcare professionals are also encouraged to report entecavir-related adverse events to the FDA's MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787.