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Subjects in this issue:
Hepatitis B drug Baraclude may cause HIV drug resistance
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. (See story on page 29.) 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 become 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 are 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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Drug tampering
GlaxoSmithKline (GSK) in April issued a letter to pharmacy professionals about a drug tampering incident found at one pharmacy in California. Two bottles were found to have counterfeit labels for one of GSK’s HIV drugs, Combivir, but contained one of the company’s other HIV drugs, Ziagen. Although an isolated incident, GSK asked pharmacies to open Combivir bottles to ensure that they actually contain Combivir. Testing found no tampering with the pills themselves, and no injuries resulted from the mislabeled bottles. The counterfeit labels had “Lot No. 6ZP9760” and expiration dates of April 2009 and April 2010 on them. The bottles themselves were legitimate.
GSK wrote, “The Combivir and Ziagen tablets are easily distinguishable. Combivir is a white capsule-shaped tablet engraved with ‘GX FC3’ on one side; the other side of the tablet is plain. Ziagen is a yellow capsule-shaped tablet engraved with ‘GX 623’ on one face; the other side is plain.”
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Wasting drug removed from market
Deca-Durabolin (nandrolone decanoate), an anabolic steroid, was taken off the market in March. The anemia medication is prescribed in what’s called “off-label use” for the treatment of HIV-related wasting. That is, the medication was never approved for wasting, but was studied in people with AIDS and is often prescribed for them. The anabolic steroid Oxandrin is still available, and is approved for HIV wasting, but is more expensive and may cause liver damage. Some HIV treatment activists have questioned the decision to remove Deca-Durabolin from the market, supposedly because Watson Pharmaceuticals ran out of active drug material to make it, when Watson at about the same time picked up the right to make generic Oxandrin. The company that produces Oxandrin, Savient Pharmaceuticals, then dropped its patient assistance program, with a generic version now available that patients can access. Wasting is associated with severe illness and death. For more information on this issue, visit http://savehivwastingmeds.blogspot.com.
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TPAN wins ConnectHIV grant
Test Positive Aware Network (TPAN), publisher of Positively Aware, received a $300,000 grant over three years from the Pfizer Foundation through its ConnectHIV initiative. TPAN is one of 20 HIV-service organizations around the country awarded. The grant supports TPAN’s five-year-old TEAM program (Treatment Education Advocacy Management). TEAM provides intensive education to people with HIV that helps them learn to more aggressively manage their health care. The program also trains service providers and volunteers, such as mentors in buddy programs.
TEAM consists of several programs that provide peer-led education in HIV treatment and prevention, and seeks to promote wellness and health outcomes in different modalities and for different targeted populations. The TEAM core training is an 18-hour secondary prevention (designed specifically for people with HIV) education training that teaches all about HIV in a class room setting both at TPAN and at other locations.
ConnectHIV is run in collaboration with the Academy for Educational Development (AED), a non-profit organization focused on human development, and the Johns Hopkins Bloomberg School of Public Health. AED works with individuals, communities and institutions, especially on education, health, and economic opportunities for disadvantaged people both in the U.S. and in developing countries.
AED and the Bloomberg School of Public Health will evaluate behavior change within the grantee communities. Behaviors that will be evaluated include actions around HIV testing, safe sex negotiation, disclosure of HIV status, condom use, access to substance abuse treatment services and support, adherence to medication and regular visits to healthcare providers.
Visit http://hivaidsphilanthropy.pfizer.com.
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