ACP’s best practice advice embraces ‘treat all’ strategy for HCV infection
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The ACP has issued clinical advice for the treatment of hepatitis C virus infection in the Annals of Internal Medicine. The advice is based on WHO’s update to its evidence-based guidance in July 2018.
“By following ACP’s Best Practice Advice, physicians can practice high-value care by offering treatment to all patients with chronic HCV infection using a ‘treat all’ strategy without any invasive testing,” Jacqueline W. Fincher, MD, ACP president, said in a press release.
The ACP noted that WHO’s recommendations were made primarily for low- to middle-income countries; however, they are still relevant in the United States.
According to the ACP, the incidence of HCV infection in the U.S. is 1.2 per 100,000 people, with a prevalence of 2.4 million cases and an annual mortality rate of more than 15,000 deaths per year. In order to eliminate HCV, authors of the best practice advice noted that 90% of infected individuals would need to be diagnosed, and 80% of those would need to receive treatment.
In its recommendation, WHO called for treatment to be offered to all patients aged older than 12 years with chronic HCV infection. They include three considerations for their “treat all” strategy.
In the first consideration, WHO cited the safety and efficacy of direct-acting antiviral agents (DAAs), as combination therapy with oral DAAs have replaced treatment with interferon and ribavirin.
In the second consideration, WHO cited the development of pangenotypic drug regimens, which simplified laboratory testing before and during treatment. The ACP noted this guidance differs from what is currently recommended by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America, which call for specific DAA treatment based on genotyping and intensive laboratory testing.
In the final consideration for HCV treatment, WHO recommends that clinicians consider reduced treatment costs, giving U.S. physicians an opportunity to reduce the cost of care without compromising quality of care.
The ACP concluded in its paper that when treating HCV infection with pangenotypic medications, viral genotyping is not necessary unless clinicians are planning treatment with glecaprevir–pibrentasvir (GLE-PIB; Mavyret, AbbVie). Then, genotyping would be necessary to identify genotype 3 and, if found, the patient would require longer treatment.
The ACP also concluded that invasive testing is not needed to determine the degree of fibrosis in patients with HCV, as inexpensive laboratory tests can reliably identify cirrhosis in these patients.
According to the organization, patients aged 18 years or older who do not have cirrhosis should receive treatment with sofosbuvir–velpatasvir (Epclusa, Gilead Sciences) for 12 weeks or GLE-PIB for 8 weeks unless they have genotype 3 infection, in which case they should receive treatment for 16 weeks.
Additionally, the ACP stated that laboratory monitoring can be conducted only during the beginning and the end of treatment in adults without cirrhosis or in those with compensated cirrhosis. They recommended closer monitoring in patients who have decompensated cirrhosis.
“PCPs play a major role and provide high value care by identifying and treating patients with [HCV] infection using treat all strategy without any need for invasive testing,” Amir Qaseem, MD, PhD, vice president of clinical policy at ACP, told Healio Primary Care. “The newer treatment regimens, their safety profile and effectiveness, and easy monitoring makes it possible for patients with uncomplicated [HCV] infection to receive care in PCP setting.”
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Advances in the treatment of hepatitis C are among the most important accomplishments that occurred in medicine recently. The Nobel Prize in Medicine was just given for hepatitis C discovery. Also recently, the U.S. Preventive Services Task Force updated its recommendations earlier this year, saying we should be screening all individuals aged 18 to 79 years for hepatitis C. Before, screening guidance had been limited to older adults. But with the increases in viral hepatitis and the advances in treatment, the current recommendations were expanded to other ages.
This paper highlights the fact that hepatitis C oral direct-acting antiviral agents (DAAs) are highly effective and associated with high cure rates, which is excellent. Providing curative hepatitis C medicines in primary care can easily be done. We should be trying to make these medicines easier for primary care physicians to administer and easier for patients to access.
There is one line in the paper that I think is really important for PCPs to note: we need to be testing everyone for hepatitis B before starting treatment for hepatitis C with DAAs. If somebody has previously been infected with hepatitis B, treatment for hepatitis C can lead to a reactivation of hepatitis B that can rapidly cause liver failure and death. There are black box warnings on the hepatitis C DAAs saying that health care providers need to test for hepatitis B and address that before starting treatment for hepatitis C. A helpful resource for this is an HHS article, “Reactivation of Hepatitis B Virus After Treatment with Direct Acting Antivirals for Hepatitis C: What You Need to Know.” When PCPs do test patients for hepatitis B — and they should be using the hepatitis B surface antigen, the hepatitis B core antibody IgG, and the hepatitis B surface antibody IgG — if they find that a patient does not have hepatitis B infection but also hasn’t been vaccinated, they should be vaccinating the patient to try to prevent hepatitis B.
Another thing the paper noted is that it is possible to noninvasively assess for fibrosis of the liver (cirrhosis/pre-cirrhosis). The vibration-controlled transient elastography (FibroScan, Echosens) is a very helpful point-of-care resource that can be used to assess the degree of liver scarring in patients with hepatitis C, rather than needing to perform a liver biopsy. It is, however, important to note that if a patient also has chronic hepatitis B in addition to hepatitis C, physicians need to consider other forms of liver imaging such as ultrasound because the FibroScan only assesses liver scarring and degree of fibrosis. Unlike in hepatitis C where patients always develop cirrhosis before liver cancer, patients with hepatitis B can develop liver cancer without cirrhosis, so hepatitis B and C coinfected patients may require other periodic imaging separate from the FibroScan.
There are a couple of other great resources for PCPs who are treating hepatitis C and hepatitis B in primary care clinics. The University of Washington has two websites: Hepatitis C Online and Hepatitis B Online. Hepatitis C Online goes through all the different treatment regimens and walks PCPs through what they need to be doing for their patients with chronic hepatitis C. Similarly, the Hepatitis B Online resource walks PCPs through everything that needs to be done in the primary care setting to manage chronic hepatitis B. Although hepatitis B has no cure, there are treatments and monitoring that patients with chronic hepatitis B might require and it is, of course, vaccine preventable.
From a policy perspective, as I said earlier, we have a cure for hepatitis C. Therefore, we should be doing everything possible to make sure that patients with hepatitis C receive treatment. In the United States, there are still Medicaid programs in some states that restrict access to hepatitis C treatment depending on the level of liver damage in a patient. Sometimes patients require a certain degree of liver scarring before they have access to hepatitis C treatment, which doesn’t make sense because the whole idea of hepatitis C treatment is to cure patients so that they don’t have complications of chronic hepatitis. There are many initiatives to try to reverse these state-level restrictions, and many states have done so. However, this is ongoing work and is something that needs to continue.
I think that the biggest thing to remember is that hepatitis B and hepatitis C both cause chronic viral hepatitis and are leading causes of liver cancer worldwide, as well as in the United States. We should be using all of the tools that we have to eliminate chronic viral hepatitis, which include hepatitis C treatment and hepatitis B testing so that we are identifying everyone with chronic hepatitis B and vaccinating all those who are still susceptible to hepatitis B. Only 25% of adults are vaccinated against hepatitis B, so we need to increase awareness around vaccination. We also need to increase primary care education and trainee education around prevention and treatment options both for hepatitis B and hepatitis C.
A final note is that ACP’s best practice advice was initially directed towards low- and middle-income countries. I have worked on global health issues as well as U.S. federal policy. It’s important to note that the prevalence of chronic hepatitis B is very high in some of these countries. It’s also rising in the U.S. in regions most affected by the opioid epidemic. On a global scale, it’s particularly important that we test for hepatitis B and initiate hepatitis B treatment in affected patients before initiating hepatitis C treatment with DAAs to avoid rapid liver failure and death in these patients.
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