Despite having a safe and effective cure for hepatitis C infection, the U.S. is failing 2.4 million Americans living with it because of an outdated and unnecessarily complicated treatment system.
Those treated for their hepatitis C live longer, have lower rates of liver cirrhosis, and lower rates of other chronic diseases like diabetes and chronic kidney disease. Yet, only 40% of those with chronic hepatitis C infection in the U.S. are aware of their diagnosis.
Even when patients have a diagnosis and seek curative treatment, the hurdles are immense – as few as 22% receive these effective therapies. Despite the 2021 development of a U.S. national strategic plan to achieve HCV elimination in 2030 in line with World Health Organization goals for worldwide HCV elimination, the U.S. is not on track to meet these goals.
This is due to a complex path to treatment, deficiencies in available rapid testing, restrictions on prescribing treatment, and a reluctance to meet patients where they are. Some states are addressing this, as in Massachusetts, where leaders recently introduced its HCV Elimination Plan.
To receive treatment, patients must first be diagnosed. This requires a visit with a doctor for a blood test to check for an antibody to the hepatitis C virus. Then, patients with a positive antibody must return for another visit to have another blood test to see if they have detectable virus in their blood.
Depending on where they live and which insurance provider they have, patients may need to have viral genotype testing to find out what strain of virus they have. They also may need to prove they already have liver damage, and they may need to see a specialist physician, or may even need to prove sobriety.
If these measures seem complex and restrictive, it’s because they were designed to filter insurance coverage for expensive, curative treatments – treatments that range in cost from $23,000 – $95,000 without insurance.
Another barrier to treatment is the outdated testing system. Available tests to diagnose hepatitis C infection must be performed in large clinical laboratories, which may result in delays to treatment and is a recognized barrier.
In the U.S., there are no approved tests to detect hepatitis C at the point-of-care. This limits both where tests can be performed and how long it takes to get a diagnosis. This lack of rapid diagnosis is particularly important for patients with hepatitis C – many of whom have little contact with the healthcare system and may not have symptoms associated with the disease for years.
COVID-19 had an adverse impact on hepatitis C elimination efforts in the U.S.. But the expanded access to rapid diagnostic testing and governmental programs created to more rapidly approve these tests also present a unique opportunity to make real progress.
Many states continue to impose restrictions on the prescription of hepatitis C treatment, including requirements for prior authorization, viral genotyping, staging for the severity of liver disease, sobriety, and specialist prescribers.
These requirements do not serve patients’ interests and need to be removed in light of high cure rates deliverable to all patients receiving these treatments and professional recommendations that all patients be treated.
Physicians often diagnose patients with hepatitis C only when they begin to experience the symptoms that come from years of liver damage. The delayed diagnosis unnecessarily allows patients to develop liver dysfunction and failure, further straining already limited healthcare resources.
It is necessary to meet patients where they are to diagnose and treat their hepatitis C. Changing this will require efforts to build on the success of advanced practice provider treatment models and increasing access to treatments in primary care as well as settings where patients have fleeting encounters with healthcare.
Those sites include substance use disorder treatment facilities, syringe service programs, mobile treatment programs, correctional facilities, federally qualified health clinics, inpatient wards, and emergency departments.
All of these limitations lead to significant losses in the cascade of care for hepatitis C, with fewer patients receiving treatment than those diagnosed with active infection.
It is possible for a future when patients could receive a diagnosis and be given treatment in the same day. Accurate point of care tests to detect hepatitis C infection are already approved abroad. Researchers have shown it is possible to effectively treat hepatitis C with fewer doctor visits for monitoring.
There must be rapid approval of available tests, funding for existing treatments, elimination of restrictions on prescribing, and simplified treatment models.
Dr. Francis Collins and Dr. Rachael Fleurence, science advisors to President Joe Biden, published a roadmap in 2023 for eliminating this deadly disease in the U.S.. The approved Biden-Harris 2024 bud
While it will take time to see the healthcare savings of this program, as lives are saved and chronic diseases are avoided, experts estimate that the benefits begin to compound after only five years.
Allowing Americans to suffer from a curable illness and spend more money to do so is unconscionable.
