|
|
|
|
||
Re: Salvage therapy market may be bigger than we think Thanks for sharing that information. Using this information, I was curious if there were any 2015 articles reporting results for studies aimed at designing new treatment regimens for HIV salvage therapy. Sure enough, I came across the 2015 publication from Tashima et al. (see link below). Quite simply, what I gathered as the take home message from Tashima et al. is alluded to in your message 77699 and the Introduction and Discussions sections I've highlighted from the article below; namely, it is extremely complicated for HIV patients "with substantial treatment resistance or treatment experience" (TR or TE) to design a new regimen that is effective without "expert involvement". In addition,& perhaps most importantly, a significant number of these HIV patients with substantial TR or TE have previously "failed to adhere to simpler, once-daily therapies", so what chance do these patients have to stick with these new more complex treatment regimens they've been prescribed? In short, as you say, it would appear to me there would seem to be a significant commercial opportunity waiting for HIV patients with substantial TR or TE if a much simpler therapeutic regimen demonstrates, in pivotal clinical trials, that...
Of course, that isn't to make it sound like meeting that standard in a pivotal clinical trial is going to be easy, but point being, by all appearances there is a market in waiting. ----------------------------------------------------------------------------------------------------------------------------------------------------------- From the Introduction section of this 2015 open access review article titled Regimen selection in the OPTIONS trial of HIV salvage
therapy: drug resistance, prior therapy, and race–ethnicity determine the
degree of regimen complexity... For patients experiencing virologic failure due to HIV drug resistance, the Department of Health and Human Services (DHHS) Panel on Antiretroviral (ARV) Guidelines for Adults and Adolescents recommends using at least 2, and optimally 3, fully active drugs to construct a new treatment regimen in order to achieve durable suppression of HIV-1 RNA levels.1 Guidelines recommend resistance testing to inform selection of new treatment regimens for patients with drug-resistant virus.1–3 Incorporating prior treatment history and patient preference such as willingness to use enfuvirtide (ENF, a fusion inhibitor), a medication self-administered by injection, are also important considerations when deciding on new treatment regimens.1–3 The decision of how many and which agents to use in the next regimen, for patients with substantial resistance or treatment experience to the first three classes of ARV agents (NRTI, NNRTI, and PI), is complicated. From the Discussion section... Designing regimens for patients who are highly treatment experienced is complicated and DHHS guidelines strongly recommend expert involvement.1 Unlike treatment-naïve patients, where HIV ARV guideline panels provide multiple specific regimen options, the selection of regimens for a more treatment-experienced patient relies on a careful consideration of treatment history, current and past resistance tests, and patient willingness to take a complex regimen with multiple drugs, twice daily dosing and sometimes an injectable agent. Decisions are even more difficult if there is a history of poor adherence.
Many patients who need new regimens, due to virologic failure and resistance, have failed to
adhere to simpler, once-daily therapies. While it is clear that including two, and preferably
three, fully “active” agents are optimal, the number of drugs needed to achieve optimal ARV
activity is uncertain when fewer than three fully active agents are available, and likely varies
for each patient due to cross-resistance within classes, archived or very low level resistance,
and the unavailability of regimens that could be constructed entirely from new, presumably
resistance-free, classes. Since the study was completed, dolutegravir, an INSTI with activity
against some INSTI-resistant HIV isolates, was approved for use in the US; dolutegravir can
be used for patients who previously received RAL and might have been useful to simplify
regimens for participants in our study.9 In this multi-center randomized trial, we developed a web-based utility that facilitated treatment recommendations for highly treatment-experienced patients. Drug resistance, prior ARV experience, and race–ethnicity were key factors in decisions to select a more complex regimen. The OPTIONS study demonstrates a successful approach to centrally implementing recommendations for treatment that are acceptable to local investigators and patients. |
return to message board, top of board |