A New Patient Perspective Study Details HIV-Therapy Preferences and Trade-Offs

by Chael Needle

[Treatment Horizons]

At the 41st International Disease Society of America (IDSA) meeting in San Diego this past October, the results of a new study about patients? preferences in regards to antiretroviral therapy regimens were reported by lead investigator Dr. Renslow Sherer and his colleagues. Addressing what patients want in relation to antiretroviral therapy, as well as their goals and ideas about treatment, is ?incredibly important to overall success of antiretroviral therapy,? says Dr. Sherer, Director of the Cook County HIV Primary Care Center, and associate professor of medicine at Rush Medical College, University of Chicago. Improving a patient?s likelihood of taking medications, once prescribed, says Dr. Sherer, can dramatically improve his or her chances of a good outcome.

In total, 367 urban-based HIV-positive patients from around the country were surveyed; ninety-three percent of them were on some form of antiretroviral therapy. Twenty-eight percent were on their first antiretroviral therapy regimen, twenty-seven percent on their second, eighteen on their third, and twenty on their fourth or more. Of course, says Dr. Sherer, there are risks and benefits associated with each and every regimen, but ?the question we tried to address is: What do patients care most about in the whole range of characteristics of antiretroviral therapy?ability to lower viral load, ability to raise T cells, ability to have a durable outcome (to last for more than a year or two), side effects, dosing frequency?? Assessing these considerations side by side, the percentages of those who rated the following ?most important? or ?very important? are: lowering viral load (ninety-five), raising T cells (ninety-four), durability (ninety-three), minimizing resistance (ninety), morphologic abnormalities (eighty-one), side effects (seventy-nine), dose frequency (seventy-five), and pill number (sixty-nine).

People cared most about the goals of therapy, ?getting it right in terms of lowering their viral load, raising their T cells, and having a durable effect,? stresses Dr. Sherer, pointing to this as the study?s most striking finding. ?This represents a tremendous evolution in the way patients view therapy?it speaks to their intelligence.? Starting and adhering to an antiretroviral regimen is ?the entire reason for the dramatic improvement in HIV mortality here in the United States. I don?t think it means that the other things aren?t important?many, many people chose side effects to be highly important?but that, at the end of the day, what they want is to be able to control the virus, have a good T cell response, and be free from the threat of hospitalizations, and morbidity and mortality.?

Other than assessing priorities, the survey posed (?in a very neutral way?) hypothetical questions to patients, based on what they knew, about specific trade-offs. Patients considered highly potent therapy versus unwanted side effects, and less potent versus better dosing schedules, or fewer pills, among other trade-offs. The researchers found, for example, that patients preferred overall efficacy over a once-daily therapy and longer lasting therapies even if that meant twice-daily dosing, among other considerations. ?In this era, we do have regimens that are once a day and are highly effective, so it?s not clear that one has to make that trade-off with all regimens; some you do. It?s hard to frame these hypothetical considerations perfectly; there?s always that question.?

Asked if the study suggested anything about patients feeling empowered by voicing their preferences and their treatment, Dr. Sherer responded: ?I think it does suggest that patients are wanting to have a greater degree of control and empowerment. Much of what is happening in HIV medicine is intended to try to improve that.? He adds, ?I don?t want to discount the importance of some of the advances made in the last few years to reduce the number of pills required, the number of doses, the food requirements?these are all great things. People are people: The simpler one can make treatment, the better.? Dr. Sherer says the research also points to further ?developing and promoting the most highly effective?that is, potent and durable?antiretroviral regimens and using those regimens early. The new HHS [Health and Human Services] guidelines just came out in July, and I think they also make a contribution toward this. For the first time, they recommend just two different regimens as being preferred initial regimens: one of them is with Sustiva (or efavirenz) and the other is with Kaletra (or lopinavir)...because these are the two different regimen types that have the best performance in clinical trials. In some ways, that lesson is being learned: When you use therapy, use the most potent.?

Chael Needle wrote about TNX-355, a monoclonal antibody entry inhibitor, in the October issue.

November 200