AIDS Action Committee’s Blog

Last week, the US Food and Drug Administration (FDA) approved the new HIV drug raltegravir, which is being marketed under the name Isentress. Raltegravir is the first approved drug in a new class of HIV meds known as integrase inhibitors. Drugs in this class fight the virus in a different way from the other classes of HIV meds. When HIV makes copies of itself, it uses the chemical integrase to insert (integrate) its genetic material (DNA) into the cell’s control center, called the nucleus. Once HIV’s genetic material has been integrated into the cell’s own DNA, the cell can become a mini-factory for making new HIV. Integrase inhibitors disrupt this process by interfering with – inhibiting – the activity of integrase.

FDA’s recent action marks its second approval of a new HIV med in a new drug class during recent months. In August, FDA approved the drug maraviroc (marketed as Selzentry), which is in a drug class called CCR5 blockers. CCR5 blockers are designed to stop HIV from entering CD4 T-cells by preventing the virus from binding to a protein called CCR5 on the cell’s surface.

The availability of new drugs in new classes is an important advance in HIV treatment. Drugs in new classes are particularly valuable for people infected with a virus that is resistant to many of the existing HIV drugs – since they offer a fresh shot at controlling the virus. However, like other HIV meds, neither raltegravir nor maraviroc can completely control the virus on their own. To be fully effective, these drugs must be given with other HIV meds as part of a combination regimen.

This week controversy broke out over a proposal to remove “gender identity” as a protected category from the ENDA. Proponents argue that removal would improve the odds of the bill passing the House and gender identity could be added after the passage. It reminds me of the arguments in the 80s about whether gay men should be identified as gay when reporting AIDS cases or whether the phrase “men having sex with men” should be used. Congressional staffers and Washington groups argued vigorously for MSM, claiming that it’d be easier to work around the homophobes and more money could be obtained for AIDS if the gay thing could be glossed over. The social scientists liked it because they argued people of color would be more easily reached than if they had to identify as gay. On the other side were activists who argued that “MSM” ignored the existence of the gay community, with its complex and non-biologically based family structure, reducing the focus to an individual and a sole behavior. The activists argued that effective intervention could not occur in isolation from people’s communities.

Well, its been over 30 years now and we’re still using MSM, got a lot of money–not enough, of course, but a lot–and we have seen a steadily increasing percentage of new infections in gay men, particularly gay men of color. Now I’m hearing the same argument for expediency to support the removal of gender identity. Transgender people are already at increased risk of HIV infection, for reasons of isolation, economic marginalization and difficulty accessing health care–familiar reasons to gay health activists. Excluding gender identity from federal protection is not going to pass the bill–no one thinks its going to get out of the Senate, but it will further fracture our community and subject a valued part of it to increased health risk. Let’s not do it again.

During the past month, some staff members at the AIDS Action Committee in Boston have been repeatedly contacted by sales reps from a company called Smart Genetics, which makes a test called HIVmirror. They’ve been asking for community input and help to spread the word about the HIVmirror.

The test analyzes the genetic structure of a person’s DNA to look for two specific mutations known as CCR5-Delta 32 and CCR2-64I.

In persons who are already infected with HIV, these mutations have been associated with slower-than-usual progression of HIV infection to AIDS. The mutations may also reduce the chances that an HIV-negative person will become infected.

Smart Genetics is marketing the HIVmirror test directly to consumers for $99. Their sales angle is that people will have additional “peace of mind” if they know they have genes that would slow the progression of HIV infection.

However, I have some serious concerns about the test and its marketing:

1) First, I don’t see any reason why a person should order this test on their own, without consulting a doctor. The test doesn’t indicate whether a person is HIV-positive or HIV-negative, so the concerns about confidentiality and stigma that motivate people to have anonymous HIV antibody tests wouldn’t apply here. There’s no stigma about having genes that might make a person a slow progressor.

2) Perhaps more important: What practical use would this information have to a person?

For HIV-positive persons: Although the presence of one or both genes might slow HIV progression, an HIV-positive person would still need to see their doctor regularly, have CD4 and viral load tests several times a year, and follow the guidelines for when to start or change HIV treatment. One danger is that, if an HIV-positive person concluded from the test that they were a “slow progressor,” they might decide to go it alone and not see a doctor regularly nor start treatment in a timely way.

For HIV-negative persons: If a person learned that they had one or both of these mutations, they might mistakenly think they were “immune” to being infected with the virus. This might lead to greater risk-taking that could ultimately increase their risk of becoming infected.

3) If a person were to have this test, I think they should do it under a doctor’s guidance. The doctor could provide context for the results, with the appropriate cautions for both HIV-positive and HIV-negative persons. But my guess is that most doctors would view the test as unnecessary, since it has few, if any, practical implications for preventing or treating HIV. That may be the reason why Smart Genetics has chosen to market direct to consumers – if you can’t find a compelling reason for a doctor to order a test, try marketing to the patient.

The POZ web site has an article from earlier this year about the HIVmirror test, with more opinions about the concerns that have been raised about it. Here’s the link.