and now, a fascinating new study published in the new england journal of medicine entitled phase 3 study of ibalizumab for multidrug-resistant hiv-1.
ibalizumab, a humanized igg4 monoclonal antibody, blocks the entry of hiv-1 by noncompetitive binding to cd4.
besides the obvious issues of cost and long-term safety outcomes, i wonder about the why the study was 25 weeks long. why not 26 weeks or 50 weeks or 100 weeks?
i wonder if diminished ibalizumab susceptibility in vitro in patients who had virologic failure would worsen with a longer duration of the study.
i also wonder if ibalizumab might have efficacy against htlv-1 or other retroviruses.
a great paper and i look forward to thoughts from experts like dr. paul sax. i’m sure those will be coming out on his blog soon. dr. carlos del rio has already written about the study.
another obvious thought is that even if ibalizumab is proven to be safe and effective, its use should be minimal. we have highly potent doultegravir-based regimens that if given with directly observed therapy should obviate the need for any humanized igg4 monoclonal antibody-based therapies.
so in my opinion, if public health is doing its job, the market for this drug would be low, and the return on investment would also be low. but public health usually isn’t getting the job done because of the skewed incentives of capitalism in health care.
what do you think? leave a reply below if you like.
philip albert lederer m.d.