COMMENTARY

Updated Guidance for Hepatitis C Virus Treatment in Primary Care

David E. Bernstein, MD

Disclosures

December 24, 2019

Imagine a chronic disease spreading through the population, shortening lives and causing untold misery. What if a few months' worth of pills could cure it? Wouldn't we do whatever we could to banish this disease from our communities?

We do have such a disease—hepatitis C virus (HCV) infection—and we do have a cure: direct-acting antiviral (DAA) therapy. What we lack is enough providers willing to diagnose, evaluate, treat, and monitor most of the infected patients in the primary care setting. Without the participation of our primary care providers (PCPs), thousands of people will face the looming specter of a liver transplant.

Against this backdrop, the New York State Department of Health AIDS Institute (NYSDOH AI) updated evidence-based HCV screening and clinical management guidelines specifically for PCPs. Treatment of Chronic HCV with Direct-Acting Antivirals is a tool to help PCPs integrate HCV evaluation and management into their practices. New information addresses DAA agents that are available and used in the United States, treating patients with "undetectable" or "indeterminate" HCV genotype results, managing HCV infection in pregnancy (including HCV screening in women who are pregnant or planning to become pregnant), and HCV testing in transgender women and individuals who are taking pre-exposure prophylaxis to prevent HIV.

At the same time, the guideline sets specific parameters for referral to a liver disease specialist. Specialist care is indicated for patients with compensated or decompensated cirrhosis, concurrent hepatobiliary conditions, extrahepatic manifestations of HCV infection (including renal, dermatologic, and rheumatologic manifestations), a glomerular filtration rate of < 30 mL/min, chronic hepatitis B virus (HBV) infection, or DAA retreatment for patients for whom first-line treatment failed. The guideline is available online and updated whenever new information becomes available.

Curing Chronic HCV Infection

Chronic HCV infection, one of the leading indications for liver transplantation and the most common chronic bloodborne infectious disease in the United States, is now curable in more than 95% of individuals treated with DAA agents. This cure rate applies to all HCV genotypes, including 1 and 3, which were difficult to treat before the advent of DAA agents. Cure has also been achieved in people who could not be cured by older HCV treatment regimens and in those with compensated or decompensated cirrhosis, advanced kidney disease (including patients receiving dialysis), or HCV/HIV coinfection. People for whom first-line HCV treatment failed are now being cured with second-line DAA treatment.

Achieving cure is easier now than in the past because DAA agents are highly effective, much easier to tolerate than older HCV treatments, taken for a short period of time, and have a low pill burden. Most DAA regimens can be administered as either a single tablet or three tablets taken once daily for 8, 12, or 16 weeks. Side effects are minimal, with approximately 10% of patients experiencing headache, nausea, or fatigue. Most people receiving DAA treatment report no side effects or that they feel better than before starting treatment.

Curing HCV infection reduces morbidity by slowing or halting the progression of liver diseases, including cirrhosis or liver cancer. With DAA treatment, liver health improves to the degree that many patients experience a reversal of cirrhosis. Perhaps most exciting is that curing chronic HCV infection has been associated with an overall increase in survival among patients with non–liver-related diseases, such as stroke and heart disease.

Striving for Eradication

On the heels of the discovery of a cure for HCV infection, the World Health Organization (WHO) set a goal of eliminating HCV infection globally by 2030. However, the United States will not meet that goal because the incidence of HCV infection is increasing among people younger than 30 years and because access to healthcare remains a significant challenge in this country.

Rising US incidence of HCV infection in people younger than 30 years. HCV infection is not distributed equally across the United States. More than 50% of people infected with HCV live in just 9 states: California, Texas, Florida, New York, Pennsylvania, Ohio, Michigan, Tennessee, and North Carolina. Many of these states are experiencing an opioid epidemic crisis. Increased opioid use among people younger than 30 years is associated with increased incidence of HCV infection in this population, creating a large population of young people in their early teens to mid-20s who are infected with HCV. Although baby boomers (individuals born between 1945 and 1965) are being diagnosed with, treated for, and cured of chronic HCV infection, new HCV infections are accumulating in younger people who use injection drugs.

Limited access to affordable care. Another significant challenge to HCV infection eradication is that many individuals who would benefit from DAA therapy cannot afford it or cannot access treatment. These drugs often have high medication copays, and insurance companies may deny coverage based on disease severity. These barriers place people who have a curable disease at risk of developing cirrhosis, liver cancer, or liver failure.

Shortage of DAA treatment providers. Access to care for HCV infection is also limited by a shortage of clinicians with specialized knowledge of HCV treatment. Treatment with DAA agents can be complicated. The DAA agents include different classes of medications that are combined for optimal effect. The mechanism of action is not the same across all drug classes, nor is the safety profile of drugs within each class. As a result, not all patients can take all DAA agents. For example, people with compensated liver disease should not take DAA protease inhibitors. To ensure effective treatment for each individual, comprehensive pretreatment assessment is essential to identifying the best DAA regimen.

HCV treatment can also have unexpected and unintended consequences. Reports of herpes simplex virus and HBV flares have prompted new recommendations for evaluation and monitoring when clinicians treat patients with HCV/HBV coinfection. These viral flares are manageable with careful observation of patients during HCV treatment and follow-up of patients whose disease is cured.

Ongoing Challenges

Prevention, diagnosis, and treatment of HCV infection remain challenges in the United States, and HCV infection is increasing in some populations. Despite the simplified treatment and cure offered by DAA therapy, the rising incidence of HCV infection secondary to the opioid epidemic and issues of affordable and accessible treatment are barriers to cure in the United States and globally. Considerable understanding of HCV infection and its treatment is still required to provide care to all people infected with HCV. The NYSDOH AI guideline focuses on increasing the number of PCPs able to treat chronic HCV infection and is an important component of the state's efforts to eradicate the disease. If successful in this endeavor, New York will help move the United States closer to achieving the WHO goal of global eradication of HCV infection by 2030.

David E. Bernstein, MD, is a hepatologist with decades of experience in treating liver disease.

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