Expert says HIV patients get too many drugs too fast
Expert says HIV patients get too many drugs too fast
Recommends shifting AIDS funds to clinical care
Keith Henry, MD, HIV Care Clinic and Program director at Regions Hospital in St. Paul, MN, has treated more than 1,000 HIV patients since 1984 and has limited his practice to HIV patients since 1985, when he opened the first HIV clinic in Minnesota. Henry, who also is an associate professor of medicine at the University of Minnesota Medical School in St. Paul, has called for an overhaul of HIV treatment and published his views in the Feb. 15, 2000 issue of the Annals of Internal Medicine. AIDS Alert asked Henry to clarify a few of his ideas on how the current health care approach to HIV should be changed.
AIDS Alert: Dr. Henry, you’ve said that antiretroviral drugs are being overutilized. Why do you believe physicians are prescribing too many drugs in a patient’s treatment regimen, and what would be a better clinical approach?
Henry: That is a complicated issue. A general response would be that I believe that too many patients are on antiretroviral therapy prematurely, which overburdens the care system with costs and problems so that the support given to the patients who really need to be on therapy — those who are clinically sick and/or have low CD4 counts (i.e., <200/mm3) — is inadequate. Thus, in our clinic, the fastest-growing category of treatment is no treatment, which is either delaying initiation or stopping therapy.
For many of the patients on therapy, three drugs as the regimen often does not seem to best fit their needs. I have many patients doing well on just two nucleoside drugs, which is a highly salvageable regimen, and many others on four or more drugs. I have learned a lot from many good clinicians that attention to nutritional, hormonal, and psychological status can be very helpful as well. Too narrow a focus on simply the HIV blood test results at the moment often resulted in patients who were not feeling well and were set up for adherence problems. Chasing side effects of aggressive therapy leads to a degree of polypharmacy that is difficult to manage well in a busy clinic.
The approach to therapy needs to be highly individualized, looking at numerous viral factors, such as rate of replication, resistance status, fitness, rate of change in viral levels, and patient factors, including nutrition, housing, commitment to treatment, HLA status, chemokine status, residual thymic function, and other medical or extenuating circumstance. I believe we can learn to better profile an individual’s chances to respond to initiation of therapy and that we should look for opportunities to safely avoid therapy, thus minimizing side effects and resistance. Since the likelihood of optimal response may somewhat attenuate with time, better data is needed on how to best approach a very long term (10 to 20-plus years) strategic approach to therapy.
AIDS Alert: Because HIV medications are so costly, federal and state money aimed at HIV treatment is mainly used to pay for drugs. You’ve said that more emphasis needs to be placed on HIV maintenance to ensure patients stick to their drug regimens. What types of medical professionals would need to be involved, and would this include directly observed therapy (DOT)?
Henry: For 1999, we estimate that only 2% of the costs of care of our HIV patients went to support the doctors and nurses directly managing patients. The bulk of the costs involve the drugs and lab costs, with specialty referrals, hospitalizations, and ER visits also important.
In Minnesota, at least, much of the costs of the drugs and lab costs are picked up by any one of many different mechanisms. However, our average cash recovery for our clinic equals about $30 per patient per month. From that we have to pay the dictation system, building expenses, etc. In fact, we were told that we lose $87 per patient visit. I calculate that for each consecutive patient visit, either the patient, their blood, or their data is handled at least 40 times in order for everything to work well. That is labor-intensive, yet the resources are going to the drug and lab costs, which are not shared with the clinic.
We utilize over 40 pharmacies for about 450 patients spread all over Minnesota and the U.S. It is extremely rare for us to get a call that the patient is behind in picking up their next month’s prescriptions. That is clue No. 1 that adherence is a problem and is a ridiculous situation. In the clinic, we are supposed to spend even more time — so that we lose even more money — to monitor adherence so that the patient can drive in and out of a pharmacy across town.
The administration of the medications needs to be more tightly controlled, with direct feedback to the prescribing physician. I get extremely frustrated when I am swamped in a clinic with side-effect issues for patients who probably don’t even need to be on therapy, yet a patient at high risk for sickness and death can’t get the help needed — including help with directly observed therapy.
AIDS Alert: How would a more intensive maintenance program be funded without exorbitant cost to the government? What are some strategies you recommend for using HIV treatment funding more efficiently?
Henry: If money could be diverted from support of drug costs to support of the clinical system, it would be easy to imagine spending the same amount of money with better overall results. More time and resources could then focus on educating and assisting patients in finding the best way to utilize precious but complicated antiretroviral therapy. I would require pharmacies to have HIV expertise and a link to the prescribing doctor as well as a program for education and adherence monitoring. As we get closer to once-a-day potent regimens, DOT becomes more practical, despite a new labor cost. Skipping once-a-day regimens will likely help foster development of resistance, so we need to learn how to make that work for the long term. Some of the side effects of therapy may relate to continuous exposure to the drugs, which is good for viral suppression. Long-term toxicity issues become a very high priority regarding what is the best approach to treatment.
AIDS Alert: Why do you believe our current approach to HIV care may fail us in the long term? Would you change your opinion if we are able to develop a successful vaccine or develop immune therapy that completely suppresses HIV?
Henry: In the real world of challenging patients, the current approach is failing at a high rate. An example is the study out of Johns Hopkins where the one-year success rate of a PI-based regimen was 37%, and that was not even using an ultrasensitive assay. Aggressive overuse of antiretroviral therapy exposes patients to side effects and resistance that may scare many needy patients away from health care.
Obviously, if a perfect therapy — i.e., a cure or lifelong suppression with low cost and no side effects — were available, then my view would change. Although efforts to pursue that goal need to be encouraged, the realistic view is that we are stuck with our current stable of drugs, so we need to cost-effectively spread their use over the next 20 years. We always will know less about resistance and long-term toxicity for new drugs, so I hope for (but don’t count on) some dramatic new drug that will alter the treatment horizon. The concept of immune-based therapies, wherein a patient’s own immune system could be groomed to control the virus, is promising but unrealized for the time being.
I believe a paradigm shift in our approach to the long-term management of HIV needs careful evaluation. Rather than a strategy involving immediate, continuous, permanent combination therapy, I think we should be working on how to use the least HIV medication in the most effective way over a 10- to 20-year period, with the goal being protection of good health. Working toward that goal also would better serve the treatment problems throughout the world, making our treatment more relevant to what is possible in resource-poor countries.
AIDS Alert: What are some of the major changes you’ve seen in your own HIV practice in the past 16 years, and how have you shifted your clinical goals and practice to handle these changes?
Henry: Our practice has grown from just a few patients to almost 500. The demographics has changed from gay white men to women and persons from a wide range of backgrounds and cultures. The expectations have grown from a minimalist crisis orientation to chronic health maintenance. Counterbalancing those trends is a practice climate that has turned hostile, with less support for indigent care, research, and education.
I honestly expect that a high percentage of patients we follow will live to their 50s and beyond. I also think that many HIV-positive patients may outlive the clinics they now attend unless resources can be shifted to support centers with an HIV clinical focus. The amazing thing is that, as an HIV specialist, I have had to learn about diabetes, coronary artery disease, hyperlipidemia, osteopenia, mitochondrial dysfunction, nutrition, hormone levels, alternative medicine, mental health, chemical dependency, family planning, and many culture- and gender-specific issues. Prior to all of that, I learned how to prevent and treat 20 or so AIDS-defining conditions and the terminally ill patient. That is quite a challenge, while still smiling and becoming an amateur businessman, as well. I am not bored!
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