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Recent advances in hepatitis C virus (HCV) treatment could be described as revolutionary: for uncomplicated patients, treatment is nearly 100% effective, oral only, has a low pill burden, minimal side effects, and results in a cure.
Comparisons we have heard from clinicians are that HCV is now easier to treat than either diabetes or hypertension. Unfortunately for many patients, their state of residence is the decisive factor for whether they will receive lifesaving treatment. As part of a tribal telehealth network for HCV, we support several rural clinics successfully treating HCV and see this dilemma all too frequently.
Consider a patient with chronic HCV infection who presents with a recent history of marijuana use and has been late picking up hypertension medication. The patient has cirrhosis and is at high risk of HCV-related mortality. He is enrolled in state Medicaid and highly motivated for treatment. What is the treatment plan? It depends on the state. A resident of New Mexico can start treatment without delay. If instead the patient lives in Montana, a state that determines treatment eligibility based on advanced liver fibrosis, documented sobriety, and compliance with existing medications, the consultation is effectively moot; treatment will be denied. Montana is far from alone in its HCV treatment restrictions. Patients in South Dakota, Nebraska, and several other states we serve face similar hurdles (see Figure).
***Center for Health Law and Policy Innovation of Harvard Law School and the National Viral Hepatitis Roundtable. Hepatitis C: the State of Medicaid Access, http://www.stateofhepc.org, accessed June 6, 2018.
These delays matter because prompt treatment saves lives. The number of deaths from HCV outnumber those caused by human immunodeficiency virus, tuberculosis, and pneumococcal disease combined.
In spite of the clinical importance of treatment, a recent study inclusive of 45 states found that about one-third of persons with HCV were denied treatment by public or private insurance.
Patients with private insurers fared even worse than Medicaid; in the same study, over 50% were denied treatment. The paradox for patients residing in states with restrictive treatment criteria is that the intended safety net of public insurance leads instead to long delays that end in denials, and the surest route to treatment is to have no insurance and be ineligible for Medicaid, a profile that qualifies for drug assistance from manufacturers.
The requirement of advanced liver fibrosis is in direct opposition to best practice and against clinical evidence. Treatment of patients in early stages of disease has demonstrated a reduction of all-cause mortality.
American Association for the Study of Liver Diseases, Infectious Society of America. Recommendations for testing, managing, and treating hepatitis C. When and in whom to initiate HCV therapy. Available at: https://www.hcvguidelines.org/evaluate/when-whom. Accessed July 6, 2018.
Regardless, the sobriety requirement, ranging from 1 to 12 months, is the norm in many states. While the impact of these restrictive policies is hard to quantify, clinicians using our HCV telehealth services have reported multiple instances of motivated patients who were lost to follow-up after the frustration of having Medicaid deny treatment.
That said, adherence concerns that underpin sobriety requirements are not completely without merit. Assessing patient sobriety is highly important. A patient should be encouraged and supported to seek reduction, cessation, or otherwise less harmful intake of alcohol, tobacco, and controlled substances. Not all patients with HCV will be ready to initiate treatment. However, the decision on if and how to proceed with treatment should be made in accordance with medical guidelines, by the patient and provider, and at the point of care.
Similarly, treating a person with HCV who is actively injecting drugs can be successful and a key part of a treatment as prevention. As with human immunodeficiency virus and tuberculosis, treating a patient with HCV has the added benefit of stopping ongoing disease transmission. In a recent multicenter trial, 97 of 103 (94%) participants who had recently injected drugs achieved sustained virologic response (cure).
Sofosbuvir and velpatasvir for hepatitis C virus infection in people with recent injection drug use (SIMPLIFY): an open-label, single-arm, phase 4, multicentre trial.
The reasons that insurers deny treatment for HCV are unclear. Prices for HCV treatment have dropped considerably in recent years. Treatment is cost effective in the long run and benefits every patient who is cured.
No other infectious disease has treatment categorically withheld because of adherence or reinfection concerns. In fact, it is standard public health practice to develop and implement measures to support adherence in patients who seek treatment for other diseases.
As this nation grapples with record levels of opioid addiction, coupled with a shortage of support services for patients who want to quit using drugs, a blanket denial of HCV treatment degrades the clinician's role, is paternalistic, harmful to the patient, and counterproductive to public health goals. Treatment restrictions will propagate disparities in liver disease mortality seen at the state level.
Public and private insurers need to align policies on access to treatment with clinical recommendations. Clinicians must work with HCV patients to ensure adherence to these costly medications.
Some states, such as Washington and New York, have adopted a comprehensive response to the HCV epidemic, largely aligned with the goals of the World Health Organization, National Academies of Medicine, and the Health and Human Services National Viral Hepatitis Plan that include not only treatment, but also the systemic elimination of HCV.
This is the path that every State, Tribe, and the Nation should follow.
Acknowledgments
The opinions expressed are those of the authors and do not necessarily reflect the official position of Cherokee Nation Health Services or Northwest Portland Area Indian Health Board.
References
Asselah T
Marcellin P
Schinazi RF
Treatment of hepatitis C virus infection with direct‐acting antiviral agents: 100% cure?.
American Association for the Study of Liver Diseases, Infectious Society of America. Recommendations for testing, managing, and treating hepatitis C. When and in whom to initiate HCV therapy. Available at: https://www.hcvguidelines.org/evaluate/when-whom. Accessed July 6, 2018.
Sofosbuvir and velpatasvir for hepatitis C virus infection in people with recent injection drug use (SIMPLIFY): an open-label, single-arm, phase 4, multicentre trial.
Funding: This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.
Conflict of Interest: JM has received speaking fees from Gilead, and is principal investigator on a Gilead grant for HCV elimination for Cherokee Nation. BR, JL, and DS have no financial disclosures.
Authorship: All authors had access to the data and a role in writing the manuscript.
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