Are you newly infected? It might help to know if your virus is drug resistant before choosing a regimen. Or it might not
Tracking HIV’s relentless evolution, researchers were dismayed to confirm last fall that not only are drug-resistant strains easily transmissible but they are already established among a significant proportion of newly infected gay men, at least in big cities in the United States, Europe and Australia. As a result, the debate over resistance testing to guide treatment is expanding. While many doctors and advocates support using such tests during treatment failure, a growing number are now calling for its routine use to help the newly infected choose an effective first combo.
One study of 80 New York City and Los Angeles residents infected in the previous two months—three-quarters of them white, gay men—found that an unfortunate 12 percent had virus resistant to one anti-HIV drug, and an even unluckier 4 percent had virus resistant to multiple drugs. Another study of recently infected gay men in five U.S. cities found a 26 percent rate of single-drug resistance and a 2 percent rate of multidrug resistance (MDR). Research in Geneva showed that 10 percent of newly infected gay men there had virus resistant to at least one drug. (Interestingly, a study of 61 injection-drug users [IDUs] recently infected in Vancouver found that none had resistant virus. This may be because, as in the United States, far fewer HIV positive IDUs—from whom these subjects probably got the virus—are on HAART than are non-IDU gay men.)
The new stats add another gloomy blotch to an already-dark picture: With MDR prevalence rising among those on anti-HIV treatment, it seems likely to also increase among the newly infected. Thus, Daniel Boden, MD, of New York City’s Aaron Diamond AIDS Research Center, recommends both a genotypic and a phenotypic test (see “A Pair of Aces,” opposite page) before choosing an anti-HIV regimen—particularly for those with acute infection (within the past 90 days). “The rate of resistance to any particular drug is high enough,” he says. “You don’t want to start with the wrong regimen.” Luc Perrin, MD, author of the Geneva study, agrees. “Your first treatment is your best chance,” Perrin says. “Once you fail that, you may knock out not just one drug but a whole class.”
But other doctors are less enthusiastic about the tests, arguing that the information is either nonessential or too hard to interpret and apply. “I wouldn’t do it up front in all new cases,” says Roger Pomerantz, MD, of Thomas Jefferson University in Philadelphia. “I would first want the patient to try HAART—and if there is no response, and you have checked for compliance and for drug interactions, then you should check for resistance.”
And even when the doctor recommends the test, insurers may beg to differ, particularly with newly infected people, about whom there’s still little data showing usefulness.
BEAT THE HOUSE
Scared your drugs are failing and wanna get pricked? Lucky you if you’re one of the five million members of California’s nonprofit Kaiser Permanente HMO system, which covers both tests when ordered by an HIV specialist. Otherwise, you may be out of luck—or major money (see “The Full Monte,” opposite page). Many insurers avoid coverage by saying that the tests are not yet FDA approved or included in federal HIV practice guidelines.
But this excuse may soon be moot, according to Oren Cohen, MD, assistant director for medical affairs at the National Institute for Allergy and Infectious Diseases. Cohen says that the January 2000 revision of the guidelines is likely to include at least some use of resistance tests. This could help spur reimbursement by Medicaid and Medicare, as well as by private insurance. In addition, FDA approval of some of the standardized test kits is expected by late 2000.
So what to do if you can’t afford the tests? Depending on your current therapy needs, you might consider enrolling in one of the many clinical trials in which these tests are run—but check that the researchers will show your doctor your test results promptly. (For a list of HIV clinical trials, call 800.TRIALS.A, or click on www.actis.org.)
Meanwhile, advocates such as Ruben Gamundi, an insurance expert at AIDS Project Los Angeles, are mobilizing. “We’ve started conversations with MediCal [California’s insurance program],” he says. “An activist coalition to address this will probably form soon.” And since Gamundi and others will argue that the tests will cut costs by maximizing the effectiveness of anti-HIV meds and minimizing expensive OI care, it’s possible that insurance companies will concede faster than usual. So let’s test their resistance now.