April 19, 2018
There's one immutable fact in solid organ transplantation -- the number of patients awaiting transplant exceeds the number of available organs.
This shortage means that ethical, medically safe strategies to increase the donor pool are always a high priority.
One such strategy would be to allow transplants from people who have chronic hepatitis C.
If the thought of transplanting an HCV-infected organ into an uninfected recipient gives you pause, you're not alone -- the practice is explicitly discouraged in some transplant guidelines.
However, HCV today is an entirely different beast than when these guidelines were crafted. Treatment is now astoundingly safe and effective, with over 95% of patients cured, typically with 8-12 weeks of simple therapy.
Not surprisingly, transplant programs are now studying the safety of conducting transplants from HCV-infected donors into HCV-uninfected recipients, then treating with HCV therapy.
While published data are still relatively sparse, two small studies in renal transplant recipients (here and here, 10 patients each), showed that HCV treatment at the time of transplant or shortly after is safe and effective. None of the 20 patients developed chronic hepatitis C.
Now a third study (led by my colleague Ann Woolley), has just been presented at the annual meeting of the International Society for Heart and Lung Transplantation.
In this trial of lung and heart transplant recipients, 33 patients received organs from donors who were HCV viral load positive; an additional 8 came from donors who were HCV antibody positive but viral load negative. The former group received an abbreviated 4-week course of sofosbuvir-velpatasvir right after transplant; the latter only received treatment if they became viremic (none has to date).
With the caveat that the study is ongoing, thus far the the regimen has been well-tolerated, with no one developing chronic HCV.
Not surprisingly, several other hepatitis C donor protocols are starting, but it's not rocket science to predict their outcomes. HCV can be effectively treated and cured (or prevented, if you interpret preemptive therapy that way) in transplant recipients, with currently available regimens.
Doing so will greatly increase the pool of available organs. In a tragic silver lining to the horrible opiate epidemic cloud over our country, premature deaths from overdoses may provide life-saving organs to patients in desperate need -- organs that previously would have been discarded due to hepatitis C. A paper published today shows that the number of donated organs from overdose deaths has already increased 24-fold since the year 2000 -- imagine what this increase would be if organs from people with HCV were permitted.
(Sorry about the silver lining cliché there -- but at least I'm in good company!)
Are there remaining research questions with this strategy? Of course -- among these include selection of the best regimen, the duration of therapy, management of drug interactions, and cost. Plus, we must recognize that these remain high risk donors who may have other infectious diseases (besides HCV) that will influence transplant outcomes.
But these are answerable questions, with none insurmountable. As noted in this excellent editorial, we've long allowed transplants from CMV-positive to CMV-negative patients -- and the antiviral regimens for CMV are far less safe and effective than those for HCV.
Can't you see a policy change coming soon?
Paul E. Sax, M.D., is director of the HIV Program and Division of Infectious Diseases at Brigham and Women's Hospital in Boston.
[Note from TheBodyPRO: This article was previously published in HIV and ID Observations, a NEJM Journal Watch blog, on Apr. 16, 2018. We have cross-posted it with their permission.]
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