A New Solution to an Old Problem: Expanding the Use of HCV+ Organs for Transplantation

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Key Points

• Transplanting HCV-infected organs to recipients without HCV, and using direct-acting antivirals to treat transplant recipients, could expand opportunities for transplant and support excellent outcomes for recipients.
• A new study from University of Colorado researchers found that in HCV treatment for people who use drugs, emocha video DOT secured higher rates of adherence compared to other adherence solutions. Participants assigned to emocha were also twice as likely to achieve 100% adherence.
• Where high adherence and dose timeliness are crucial—like in transplant recipients—emocha video DOT can offer better precision and more certainty of adherence.

Another patient is added to the waiting list for organ transplants every nine minutes. More than one hundred thousand people are waiting for transplants at any moment—and every year, several thousand die or become too sick to receive a transplant. This is in part due to the perpetual shortage of approved organs. But a new class of drugs called direct-acting antivirals (DAAs) offers the promise of an expanded source of qualifying donor organs and more lifesaving transplant surgeries. By transplanting organs from donors infected with hepatitis C virus into recipients who are uninfected, and then immediately beginning an HCV treatment course for the recipient, transplant centers can achieve excellent outcomes for their patients using an expanded donor pool.  

An effective but expensive cure for HCV

DAAs, in the form of a once-daily oral tablet, can now clear the HCV infection in twelve weeks or less. Since the first DAA was approved by the FDA in 2014, the most common chronic blood-borne disease in the United States is now curable in more than 90% of patients, with minimal side effects. And this means that transplant recipients who receive an otherwise healthy but HCV-infected organ can be cured, too.

Adherence is a crucial element to HCV treatment and cure; researchers point to non-adherence as among the most important risk factors for HCV treatment failure. Likewise, non-adherence is also known to be a major predictor of rejection, graft loss, and death among solid organ transplant recipients. Adding DAAs for HCV treatment presents yet another adherence challenge for these vulnerable patients. DAAs also come with a steep price tag: a 12-week treatment course of the DAA ledipasvir/sofosbuvir (Harvoni®), a direct-acting antiviral, costs $94,500, though the availability of generic versions and insurance coverage can both reduce the price for patients. Both private and public insurers regularly deny coverage for these drugs, even when physicians prescribe them. Patients who receive HCV-positive organs, then, are responsible for lifelong immunosuppressant medications as well as an immediate course of essential treatment for HCV infection.

Promising results for patients with HCV

A new paper published by University of Colorado researchers underscores the promise of DAAs in HCV treatment and the value of video Directly Observed Therapy (DOT) for medication adherence. The INCLUD study compared video DOT with wireless pillboxes to assess adherence and cure from HCV with direct-acting antivirals in people who use drugs. This research included participants who would often not receive coverage for HCV treatment, as payers sometimes require patients to have advanced liver disease, or to abstain from alcohol and illegal drugs, in order to access the medication.

Participants, who were all HCV positive and self-reported drug use, were randomly assigned to emocha’s mobile application or to a wireless pillbox for the 12-week period, and then had their sustained virologic response (SVR) measured. Across all participants, more than 80% of participants achieved a cure. Their adherence ranged from suboptimal—as low as 30%—to 101%, illustrating just how effective DAAs are at curing HCV even with imperfect adherence.

Patients assigned to emocha video DOT were more than twice as likely to complete all doses and achieve 100% adherence than those assigned to wireless pillboxes. Further analysis also showed that being assigned to emocha’s video DOT platform decreased the odds that a patient would miss 1 or more doses. Results indicate that new HCV medications are remarkably effective in patient populations often considered poor candidates for treatment, and even without perfect or near-perfect adherence. Among emocha users, a 98% percent median adherence among patients who were cured and a higher likelihood of perfect adherence reinforce how video DOT supports patients in achieving superior adherence to their medications.

emocha for transplant recipients: providing more certainty in adherence

A comprehensive medication adherence program like emocha’s video DOT can assist post-transplant patients who are prescribed both DAAs and immunosuppressive therapies in achieving higher rates of adherence and successful transplants. In transplant recipients, particularly those who are at high risk for adverse outcomes, emocha video DOT can offer more precision and certainty of adherence in the critical post-transplant period.  Clinical research into the outcomes for liver, kidney, lung, and heart transplant recipients continues to show that these transplants are not only safe for patients but also cost-effective compared to waiting on a transplant list. Recipients who receive HCV-positive but otherwise healthy organs can now be cured post-transplant, and a holistic solution to medication nonadherence can help ensure these more complex transplants succeed.

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