Laird Harrison

October 11, 2017

CHICAGO — Although new treatments can effectively cure most cases of hepatitis C, outdated guidelines, too many treatment choices, and lack of insurance coverage can make standards of care difficult to implement, experts acknowledge.

"It may not always be clear what the standards of care are," said Nancy Reau, MD, from the Rush University Medical Center in Chicago, who is cochair of the conference. "And providers may not always be able to provide standard of care."

Standards can come from official guidelines, practice patterns, package inserts, or legal considerations, said Dr Reau, who teamed up with Wendy Spearman, MBChB, PhD, from the University of Cape Town in South Africa, to provide an overview of the problems with standards here at the International Conference on Viral Hepatitis 2017.

Because many therapies have been approved for hepatitis C — some very recently — it can be "very difficult to pick one," she pointed out. "When your patient has many therapeutic options, our guidelines give you suggestions and good ideas, but may not help you pick one over another."

Dr Reau explained that when she checked the guidelines issued by the European Association for the Study of the Liver (EASL), she found outdated versions on the organization's website and considered them not to be user-friendly.

Guidelines issued by the American Association for the Study of Liver Disease (AASLD) have evolved. They are now more user-friendly and are supposed to be updated in real time, with the newest therapies being incorporated within about a month of approval, she said.

But even when a practitioner finds applicable guidelines and tries to implement them, barriers can arise.

Insurance Hurdles

One of the biggest hurdles in the United States is insurance coverage; many state Medicaid programs will not pay for the treatment of patients who abuse drugs or alcohol or whose disease is not advanced.

Such regulations can make it difficult to retain patients. Although some guidelines advise that testing for illegal drug use is not appropriate, some payers require such testing, she explained.

"It's one thing to look at the patient in front of you and prescribe a treatment," Dr Reau noted, but it's another thing to tell a patient in front of you to wait 3 to 5 years for access to treatment.

Shortening treatment duration would help "chaotic" patients who have only a short period of stability in their lives. But usually shortening duration requires the imposition of restrictions, such as testing for comorbidities, genotypes, and drug resistance, and monitoring for drug interactions.

More one-size-fits-all treatments might lead physicians to become "cavalier" and overlook cirrhosis or renal insufficiency or to prescribe a regimen to a patient unlikely to be compliant, Dr Reau said.

Patients, too, might become cavalier and decide not to take the full course of a prescription, she said.

But barriers to care in the United States are minor compared with those in sub-Saharan Africa described by Dr Spearman.

Barriers to Care

Although relatively inexpensive generic versions of drugs to treat hepatitis C are available in the region, patients there have never had access to them. Only 6% of cases in the region are diagnosed, she reported, but the incidence is increasing.

"There is unfortunately a lack of state-funded harm-reduction services," she said. State-of-the-art diagnostics, such as RNA tests, are not available in most places. Blood donations are now being tested, but there are few needle-exchange programs, and criminalization makes it difficult to reach men who have sex with men.

Standards of care are hard to apply in sub-Saharan Africa, not only because of a lack of resources, but also because the distribution of genotypes and the routes of transmission are different, she added.

And medical instruments and syringes — for scarification, circumcision, and other procedures — are sometimes reused, which can spread hepatitis.

Countries in sub-Saharan Africa lack trained healthcare workers. However, Dr Spearman said she is hopeful that programs that use video conferencing to train and mentor healthcare providers, such as Project ECHO from the University of New Mexico, will help.

Given the challenges, session moderator Kosh Agarwal, MD, from King's College Hospital in London, asked whether the World Health Organization guidelines are getting much traction in sub-Saharan Africa. Sadly, Dr Spearman replied, they are not.

Dr Reau reports relationships with AbbVie, Gilead, Merck, Bristol-Myers Squibb, Boehringer Ingelheim, and Intercept. Dr Spearman has disclosed no relevant financial relationships. Dr Agarwal reports relationships with Gilead, Merck, AbbVie, and Bristol-Myers Squibb.

International Conference on Viral Hepatitis (ICVH) 2017. Presented October 10, 2017.

Follow Medscape Gastroenterology on Twitter @MedscapeGastro and Laird Harrison @LairdH

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