Care and Cure: Hepatitis C

July 25, 2019|4:05 p.m.| Marcus Plescia, MD, MPH | Chief Medical Officer, ASTHO

On July 28, we recognize World Hepatitis Day, with the World Health Organization urging all countries and partners to “Invest in Eliminating Hepatitis.” The prospect of doing so in the United States is realistic. When antibiotics were first introduced with the discovery and mass production of Penicillin in the early 20th century, our ability to treat bacterial infections that once devastated communities and populations changed dramatically. The recent development and production of antiviral medications is a similarly historic and seminal event in modern public health. The development of multi-drug antiretroviral combinations in the 1990s curtailed the HIV epidemic by inhibiting the spread of the virus and preventing progression to AIDS. But the introduction of highly effective antiviral treatments for hepatitis C in 2014 marks the first time we have been able to cure a major and highly-infectious virus.

Hepatitis C infection (HCV) has reached epidemic proportions; the human burden is substantial. An estimated 2.4 million people in the United States are living with chronic hepatitis C, putting them at significant risk to develop fatal liver cirrhosis and cancer. Since 2012, the virus has led to more deaths than 60 other nationally notifiable infectious diseases—including HIV and pneumonia—combined. Deep inequities underpin the epidemic, which is more pronounced in central Appalachia and among Native American populations. Following the discovery of hepatitis C in the late 1980s, public health interventions to secure blood transfusions led new cases to fall significantly. However, the opioid epidemic has led to a dramatic rise in infection, with cases increasing 3.5 times from 2010-2016, particularly in young people and people who inject substances. Currently, only half of individuals with active infection have been screened and know they are infected. Recent increases in the incidence of HCV has led some experts to recommend broader population-based screening, point of care testing, and greater adoption of institutional interventions like standing orders, electronic reminders, and monitoring provider benchmarks.

Sadly, the human ingenuity that led to the development of a cure for hepatitis C has been stymied by stigma, fear, and a failure to execute basic infection control interventions. Hepatitis C treatments are highly effective, with cure rates of 90% and higher for 8-12 week regimens, have high safety profiles and few adverse side effects. However, the initial cost of hepatitis C medications led to widespread, non-medically sound restrictions limiting use to those who were “sober,” in late stage of disease, and under the care of an infectious disease or gastroenterology specialist. Fortunately, these barriers are now being addressed due to federal mandates, legal action, public health advocacy, and reduced medication pricing. The Hepatitis C: State of Medicaid Access project tracks barriers to hepatitis C treatment in state Medicaid populations. Several states are making progress in reducing treatment restrictions, but considerable work needs to be done to ensure widespread access to curative treatment.

Recent attention has focused on state negotiations with pharmaceutical manufacturers to procure hepatitis C drugs at more affordable and predictable costs. Washington state and Louisiana have both emerged as early adopters by negotiating a modified subscription model with manufacturers. Colorado, Michigan, and Oklahoma have received CMS approval to negotiate similar agreements. The media coverage of these arrangements (often dubbed “the Netflix model”) has been slightly confusing. Essentially both states have negotiated an exclusive contract with one manufacturer who will (1) provide a pre-selected hepatitis C medication, (2) at a negotiated price, (3) with a preset maximum total annual expenditure for the state, and (4) for a defined number of years. A substantial rebate will be provided to the state should demand exceed the threshold expenditure. Therefore, the annual costs for the state will be predictable since the cost of any additional demand for medications will be negligible and access to treatment becomes virtually unrestricted in these populations.

Earlier this month, at the CDC-ASTHO National Viral Hepatitis Program Planning Meeting, Jonathan Mermin, director of CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, declared that elimination of hepatitis C, now a CDC winnable battle is within reach. Elimination is the reduction to zero of an infection or disease in a defined geographic area via deliberate control mechanisms that must be continued to prevent reemergence. While surveillance, testing, and access to highly effective treatments are core approaches to eliminating hepatitis C, effective disease control interventions are also necessary. People who inject substances account for 3 out of 4 new cases of hepatitis C. Dramatic increases in opioid use in the United States are responsible for much of the recent increase in hepatitis C. Access to medication assisted treatment for opioid use disorder has emerged as an important evidence-based intervention to reduce harm and ultimately reduce addiction, but states have struggled to meet these treatment needs.

Access to sterile injection equipment has emerged as a particularly effective method to control the spread of hepatitis C and, when combined with treatment for opioid dependency, can reduce transmission risk by more than two-thirds. In 2018, a total of 318 Syringe Services Programs (SSPs) operated in the United States. CDC estimates that 2,200 are needed. States can act to increase SSPs by authorizing syringe exchange statewide or in selected jurisdictions. In 2019, twelve states still require legislative action to permit SSP operation. State laws related to drug paraphernalia also limit access to safe injection equipment. States can decriminalize possession or distribution of syringes or needles by exempting needles or syringes from the definition of drug paraphernalia or limiting prosecution when possession is voluntarily disclosed. Ultimately, allowing the retail sale of needles and syringes for individuals who inject drugs would significantly increase safe injection practices. To date, three states (Maine, Nevada, and Utah) have implemented these comprehensive approaches to prevention.

More states should do the same. The prospect of eliminating hepatitis C is within our reach. Despite the significant challenges of addressing a highly stigmatized disease, hepatitis C offers public health leaders an opportunity to impact health on a scope and scale that is seldom seen.