Dr Rabkin on PROVIGIL

[Guest guest]

MY QUESTION TO DR RABKIN

Dear Dr Rabkin:

I hope you are well. I am happy to see that you are doing a study with my favorite drug nowadays (Provigil). I think this drug has a very important place in HIV related fatigue and depression. However, I am concerned about potential med interactions since it uses the P450 cytochrome path. Are you looking at protease blood levels in your study? Or are you just watching viral loads to see if any breakthroughs happen?

FROM DR RABKIN

Greetings, : While theoretically it would be excellent to carefully study the effects of Provigil on each antiretroviral agent, as Cephalon did with contraceptives, we figured it would take several hundred healthy volunteers and several years of work. Not what we do, nor fiscally feasible. So we're doing as you say: monitoring CD4 and viral load after 4 weeks for patients taking either Provigil or placebo, and again after 12 weeks of active treatment (and 26 weeks for those still taking Provigil at follow-up). We see no pattern of change so far. We tried grouping patients by the class of antiretrovirals as well (protease inhibitors included in regimen or not). Again no pattern. Some go up, some go down. I'm sending you our open label pilot study results which gives an idea of our measures. The worst part of Provigil is the cost. As a psychopharm friend of mine puts it, "the major side effect is poverty." While Medicaid covers the cost, ADAP does not. Most of our patients have Medicaid but for the exceptions, there is no easy solution. My great interest is to get people"moving" again - out of the house and engaged in something productive and interesting, whether volunteer work, classes, degree programs, or paid employment. Some patients who enter the study do just that; others really aren't about to alter their pattern of going to day programs for groups and free meals, they just go more regularly. Others make no changes by choice. I think there's a great need nowadays for programs to assist in returning to work - not an easy challenge but timely, in my opinion. Vocational rehabilitation (or "habilitation" for some) is not my field, but it would be a significant contribution if someone designs such programs.

Regards, Vergelpowerusa dot org"I learned that...no one is perfect but most people are good; that people can't be judged only by the worst or weakest moments; that harsh judgements can make hypocrites of us all; that a lot of life is just showing up and hanging on; that laughter is often the best, and sometimes the only response to pain." My Life by Bill Clinton