Resistance

HIV/HBV coinfected patients should not take entecavir unless on anti-HIV treatment due to resistance risk

Michael Carter
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The anti-hepatitis B drug entecavir (Baraclude) should not be prescribed to HIV-positive individuals unless they are taking potent anti-HIV therapy, the US Food and Drug Administration (FDA) and maker of the drug, Bristol-Myers Squibb (BMS) are warning.

BMS has issued a “Dear healthcare professional” letter warning that the use of entecavir by HIV-infected individuals who are not taking antiretroviral therapy could lead lead to the development of stains of HIV with resistance to drugs from the nucleoside reverse transcriptase inhibitor (NRTI) class.

Data presented to a conference earlier this year indicated that entecavir had enough anti-HIV activity to generate resistance in patients who were not taking effective anti-HIV therapy. You can read the aidsmap.com news report here

Glossary

hepatitis B virus (HBV)

The hepatitis B virus can be spread through sexual contact, sharing of contaminated needles and syringes, needlestick injuries and during childbirth. Hepatitis B infection may be either short-lived and rapidly cleared in less than six months by the immune system (acute infection) or lifelong (chronic). The infection can lead to serious illnesses such as cirrhosis and liver cancer. A vaccine is available to prevent the infection.

reverse transcriptase

A retroviral enzyme which converts genetic material from RNA into DNA, an essential step in the lifecycle of HIV. Several classes of anti-HIV drugs interfere with this stage of HIV’s life cycle: nucleoside reverse transcriptase inhibitors and nucleotide reverse transcriptase inhibitors (NRTIs) and non-nucleoside reverse transcriptase inhibitors (NNRTIs). 

nucleoside

A precursor to a building block of DNA or RNA. Nucleosides must be chemically changed into nucleotides before they can be used to make DNA or RNA. 

Food and Drug Administration (FDA)

Regulatory agency that evaluates and approves medicines and medical devices for safety and efficacy in the United States. The FDA regulates over-the-counter and prescription drugs, including generic drugs. The European Medicines Agency performs a similar role in the European Union.

A boxed warning on packets of entecavir will now caution: “Limited clinical experience suggests there is a potential for the development of resistance to HIV nucleoside reverse transcriptase inhibitors is Baraclude is used to treat chronic hepatitis B virus infection in patients with HIV that is not being treated. Therapy with Baraclide is not recommended for HIV/HBV co-infected patients who are not also receiving highly active antiretroviral therapy (HAART).”

Healthcare providers are also being cautioned that no patient should start treatment with entecavir until they have had an HIV antibody test.

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Resistance
Hepatitis & HIV
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