Hepatitis B drug Baraclude may cause HIV drug resistance

The hepatitis B drug Baraclude (entecavir) can cause drug resistance to some HIV medications.

On February 24th, Bristol-Myers Squibb sent a letter to health care providers warning them about using Baraclude in people co-infected with both hepatitis B virus and HIV, but who are not taking HIV therapy. The panel that puts together HIV treatment guidelines for the U.S., however, now recommends that co-infected people not be given Baraclude unless they’re also being treated for HIV.

The company received a case report on a co-infected man taking Baraclude for his hep B, but nothing for his HIV. It was found that his HIV had developed the resistance mutation M184V.

In other words, Baraclude—like the HIV drugs Epivir and Emtriva—selects for the M184V mutation. Viruses can develop mutations that allow them to evade drug treatment. Because the drugs affect viruses in a concrete physical way inside the body, if the virus mutates – changes itself – it can then make a drug ineffective.

This man had previously taken the anti-HIV drug combination of Viramune, Retrovir, and Epivir. This finding is a concern for co-infected people not taking HIV medication because if and when they decide to go on HIV therapy, their HIV may have already developed some drug resistance.

Of all the resistance mutations that HIV can develop, however, M184V is seen as the most unproblematic, and even favorable (for example, T-cells continue to rise).

This man also had a one log drop in his HIV viral load while taking Baraclude. In two months, his viral load went from 35,000 to 2,000, and then continued to stay below 35,000. There were also two other cases in which co-infected people not taking HIV treatment had a one log drop in their HIV viral load while taking Baraclude. To see the new government recommendations, provided as a supplement to the HIV treatment guidelines, go to http://www.aidsinfo.nih.gov/contentfiles/EntecavirInHIV.pdf.

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Women in HIV vaccine study wrongly told they are positive for the virus by outside medical providers

The HIV research team at the University of Illinois at Chicago reported a third incident in which a participant in an HIV vaccine study was erroneously told she was HIV-positive by her doctor. Research coordinator Parrie Graham noted that this incident was the “most troubling” of the three. First, the study participant was refused her birth control shot unless she took an HIV test. Secondly, she tried to tell her doctor she was in a vaccine study that could cause her to test positive for HIV when she wasn’t, but he wouldn’t listen to her as he gave her the positive result.

There are several problems with this situation. First of all, people are frightened into thinking they have HIV when they do not. Worse, they could think they may have gotten infected through the vaccine study itself, when that is not a possibility. If people start believing that you can get infected through a study, the search for an HIV vaccine could be greatly held back. Ironically, vaccine studies require many more individuals – tens of thousands – than other studies. To compare, many HIV trials only require several hundred patients.

And why, after almost a year of attending the same medical clinic for the same services, was this woman refused her Depo-Provera shot if she didn’t take an HIV test? The vaccine study staff believes it could be due to relatively new recommendations for expanded HIV testing. In September, the U.S. Centers for Disease Control and Prevention (CDC) recommended that medical clinics offer HIV testing to virtually all patients.

People joining an HIV vaccine study receive a very careful explanation of the risk of testing positive for the virus when in fact they are HIV-negative, and asked to turn down an HIV test.

(Author’s note: I am a member of the Community Advisory Board – CAB – at UIC for this vaccine trial.)

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