The LEAP team joining the NYC community on the sunny steps of City Hall on May 15, 2019, as part of Hepatitis Awareness Month.
Hepatitis C virus (HCV) is affecting more women now than in previous decades. Many of these women are of child-bearing age. HCV largely affects men in the “baby-boomer” population, or adults born between 1945 and 1965. However, a new wave of HCV infections has started to affect younger men and women due to intravenous drug use.
A recent report from the Centers for Disease Control and Prevention noted that HCV infection has been increasing in women of child-bearing age, particularly in the rural area of Appalachia. The report found that between 2011-2014, increased HCV detection among women of child-bearing age and testing of children under two were observed both nationally and in Kentucky (by 22 percent detection in women and 14 percent testing in children under two nationally; for Kentucky the corresponding increase was 200 percent for detection and 151 percent for testing HCV among these populations). Further, the proportion of babies born to HCV-infected mothers increased by 68 percent nationally and 124 percent in Kentucky.
HCV was called the “mystery virus” when patients were first diagnosed in the 1970s. Before the virus was identified in the early 1990s, the medical community called it “non-A, non-B hepatitis.” Researchers pursued this unknown virus that was largely asymptomatic, though complications from HCV include decompensated cirrhosis, which presents with a buildup of toxins resulting in yellowing of skin, tar-ish stool, and psychological confusion. Risk factors for acquiring the virus were found to be largely blood-borne, including sharing contaminated drug items and tattoo or piercing needles. Other factors now include medical transmission through a pre-1992 blood transfusion or organ transplant, sexual transmission, and prenatal transmission.
HCV is easier to cure now than ever before. New treatments introduced after 2011 are highly effective, boasting more than a 90 percent cure rate and few side effects. These drugs, called Direct Acting Antivirals (DAAs), are taken once a day for 8-12 weeks for most patients diagnosed with HCV. However, patients with HCV may face many barriers in getting these medications. As health care advocates, we must challenge the health system to put patients first, and extend additional efforts to cure an infected population facing complex comorbidities and psychosocial barriers to care.
HCV presents unique challenges to pregnancy and reproductive health. In 2015, the New York State Department of Health noted that in New York State, “57% of female cases of HCV were of child-bearing age.” A recent weekly update from the Centers for Disease Control and Prevention reported that approximately 68 percent of pregnant women with HCV infection also have opioid use disorder. The American Association for the Study of Liver Diseases and the Infectious Diseases Society of America now recommend HCV screening for all pregnant women. Increased screening during prenatal care can lead to an expanded sphere of testing that includes partners and children. Currently, children are still rarely screened for HCV.
Tatyana Kushner, MD, a hepatologist with a joint appointment in OB/GYN at The Mount Sinai Hospital, says that women are particularly affected by the spike in intravenous drug use. Women, she notes, may engage in particularly high-risk behaviors specific to intravenous drug use. She states that “women who inject drugs appear to have a higher risk of incident HCV, possibly due to higher risk-injecting behaviors compared to men. Women are more likely to be injected by others, more frequently to be injected by sex partners, and more likely to engage in high-risk sexual behaviors for drugs than their male counterparts.”
Dr. Kushner also highlights the challenge of linking HCV infected patients to care, citing research indicating that out of the approximately 3.5 million people estimated to be living with chronic HCV infection, 50 percent are aware of their diagnosis, just 16 percent have been prescribed treatment, and only 9 percent have achieved sustained virologic response. The steep drop in participation at each point of contact for HCV patients reflects the challenges of medical intervention in this at-risk population, and suggests that pregnancy can be used as an opportunity to diagnose new HCV infection among women who may otherwise not present to health care.
HCV treatment during pregnancy remains a controversial topic, since more data is needed to accurately represent current HCV treatment safety in pregnancy. The Food and Drug Administration has warned that the earlier HCV treatments interferon and ribavirin are teratogens, which may cause abnormalities in fetal development. Direct Acting Antivirals, however, are not classified as teratogens. Some hepatologists, including Dr. Kushner, advocate treating pregnant women with DAAs during pregnancy to reduce the risk of passing the virus on to children, which is uncommon but is thought to occur at or around the time of delivery. Many HCV DAAs are not associated with toxicity in animals, but human data is limited. According to Dr. Kushner, DAAs used in the third trimester after embryonic organogenesis is already complete can significantly decrease a high viral load in a matter of weeks and is likely to reduce mother to child transmission.
Linking patients with HCV to care, including the younger female cohort, can improve future health outcomes by positively reinforcing each point of contact between the patient and the health care system with care coordination initiatives.
What resources do we have to help connect vulnerable patient populations, including pregnant women, to care? The Liver Education and Action Program (LEAP) works to improve engagement in persons living with HCV infection as part of the Institute for Liver Medicine at Mount Sinai Health System. Led by Medical Director Ponni Perumalswami, MD and Behavioral Director Jeffrey Weiss, PhD, the LEAP program advocates for a system-wide approach to HCV screening and linkage to care that includes patients seen in the inpatient, outpatient, and emergency department units.
Our patient navigators help link persons who screen positive for HCV to follow-up care, while our care coordinators and peer navigators guide linked patients through the HCV treatment process. Patient navigators provide education and counseling, assist with scheduling appointments, and offer to accompany patients to appointments with peer navigators.
Since 2018, LEAP has partnered with the Mount Sinai Beth Israel Emergency Department in a comprehensive effort to screen patients in New York presenting at the Emergency Department for HCV. The program then uses its unique care coordination resources to effectively link infected patients to HCV care.
As a patient navigator with LEAP, it is my job to empower patients to feel like they are at the helm of their health journey. My role is part customer service and part advocacy. After speaking with the patient on the phone, I want them to know that they are in control of when and why they go to the doctor. I want to provide them with as smooth an entry into care as possible by helping them interact with insurance, medical record acquisition, and referrals.
A patient navigator is an important advocate for patients who need support when embarking on an HCV treatment regimen. Patients can call a patient navigator if they are billed incorrectly by the clinic, if they aren’t treated well by the front desk, or if they are having a hard time scheduling an appointment or transportation. The role is flexible, and provides patients with as much or as little support as they need. Efforts to provide patients with testing options, transportation, referrals to Mount Sinai’s social work office for financial support, reminder calls, appointment scheduling, and emotional support have contributed to positive changes in the health and lives of patients.
Drs. Perumalswami and Weiss also created HepCure, an innovative electronic web-based application that enhances patient engagement by providing resources directly to patients and offering a secure communication tool between patients and their providers. HepCure also sponsors weekly webinars that update the medical community on a range of HCV-related topics, including the evolving epidemiology of the virus and new trends in diagnostics, testing, and treatment.
The increased incidence of HCV among reproductive-age women presents significant public health challenges. These challenges are matched, however, by an enormous opportunity to support patients when they need it most. Care coordination programs utilizing patient navigators can provide substantial opportunities to increase the quality of life for some of NYC’s most at-risk patients by linking them to the health care system—for good.
Colleen Stapleton is a patient navigator with the Liver Education and Action Program (LEAP) at The Mount Sinai Hospital, where she works to improve care for patients living with hepatitis C.