ANY British Columbian living with chronic hepatitis C now is able to access treatment, regardless of the severity of their disease, Health Minister Adrian Dix announced on Tuesday.
In addition to expanding coverage to all British Columbians, a new chronic hepatitis C drug has been added to the PharmaCare formulary.
“In years past, a hepatitis C diagnosis was a stressful and lifelong struggle,” said Dix. “I’m pleased to share that, as of today, anyone in B.C. living with this now-curable virus will have a choice of several treatment options – all of which are fully funded under PharmaCare.”
UKIAH, Calif. — Once a week, Dr. Diana Sylvestre puts her medical expertise to use in a rickety old house frequented by drug users in this small Northern California city.
She sets up in a stuffy office no bigger than a walk-in closet, just feet from a room where people who shoot heroin or methamphetamine drop off used needles and pick up clean ones. The needle exchange and Sylvestre’s makeshift clinic are under the same roof, part of a program run by the Mendocino County AIDS/Viral Hepatitis Network.
Sylvestre comes here in part to treat young drug users, people who are often homeless or suffering from mental illness, many of them newly infected with hepatitis C. She doesn’t see many of them at a hepatitis C clinic she runs in Oakland.
The Delaware resident was diagnosed with hepatitis C more than two years ago, but she doesn’t qualify yet for the Medicaid program’s criteria for treatment with a new class of highly effective but pricey drugs. The recent approval of a less expensive drug that generally cures hepatitis C in just eight weeks may make it easier for more insurers and correctional facilities to expand treatment.
The drug, Mavyret, is the first to be approved by the Food and Drug Administration that can cure all six genetic types of hepatitis C in about two months in patients who haven’t previously been treated. Other approved drugs generally require 12 weeks to treat the disease and often aren’t effective for all types of hepatitis C.
An innovative solution to the high cost of prescription drugs is emerging in one of the unlikeliest places: Louisiana’s state government.
The Louisiana health secretary, Dr. Rebekah Gee, has called attention to the plight of tens of thousands of state residents suffering from infection with the hepatitis C virus who cannot afford lifesaving treatment. She also is publicly considering the idea of asking the federal government to invoke a century-old law to help them. Using this law, the government could authorize a generic drug company to make a copy of an existing hepatitis C medication more than a decade before patents are due to expire. The pharmaceutical industry has strongly objected, arguing for unrestricted power to set prices.
What happens next could answer the critical question of what comes first: the pharmaceutical industry’s power over pricing or the public’s health.
Summary: Study published in Annals of Internal Medicine found no differences in sustained virologic response among patients treated for HCV infection by specialists, primary care physicians, and nurse practitioners.
The introduction of direct-acting antiviral (DAA) therapy for hepatitis C virus (HCV) infection has resulted in a well-tolerated treatment regimen and high rates of cure that have brought the possibility of widespread treatment and cure for patients with chronic HCV infection even closer to reality. Unfortunately, with roughly 2.7 million Americans living with HCV infection and only about 20,000 specialists (gastroenterology-hepatology and infectious disease physicians) in the United States, the current specialist workforce is not large enough to treat all the people who will need it.
A recently published study looked at whether nonspecialist healthcare providers could help meet the treatment needs of Americans with HCV. This supports one of the goals of the National Viral Hepatitis Action Plan (NVHAP), which calls for building the capacity of the health care workforce to improve access to treatment for persons infected with HCV.
One approach to improving access to HCV care and treatment is task shifting, which involves the redistribution of work activities among various healthcare workers. This strategy- training non-specialists to practice independently of specialist supervision- can also help to make better use of health workforce resources overall. However, information on the success of this approach for viral hepatitis is limited.
To shed light on this issue, a clinical trial was conducted at 13 community health centers in Washington, D.C. The Phase IV pilot study to “Assess Community-Based Treatment Efficacy in Chronic Hepatitis C Monoinfection and Coinfection with HIV in the District of Columbia” (ASCEND Study) evaluated the effectiveness of HCV management and treatment by three types of providers – specialists, primary care physicians (PCPs), and nurse practitioners (NPs).
Six hundred patients with chronic HCV infection were enrolled to receive treatment with ledipasvir (LDV) and sofosbuvir (SOF) from 1 of the 3 provider types including 6 specialists, 5 PCPs, and 5 NPs. All received training prior to study initiation. The goal of the treatment was SVR- also known as a cure, defined as an undetectable HCV RNA viral load 12 weeks after the end of treatment. Results of the study showed that 86% (516 patients) achieved SVR.
Response rates for patients achieving SVR were similar across the 3 provider types as follows: NPs, 89.3%, PCPs, 86.9%, and specialists, 83.8%. Of the 84 patients who did not achieve SVR, 45 were lost to follow up, 35 had viral relapse, and 4 died.
The results show that nonspecialist providers can safely and effectively use DAA-based HCV therapy in real-world community health centers. Visit the Annals of Internal Medicine [ PDF, 191KB] to read the entire research study.
Importantly, there were high cure rates even in patients with HIV coinfection, cirrhosis, or previous HCV interferon treatment experience. The results of this study suggest that with newer DAA therapy, nonspecialist providers can be rapidly trained to offer a single stop “diagnosis-linkage-treatment” continuum for uncomplicated HCV infection cases and avoid the need for specialist referrals.
“The most effective way to reduce deaths and improve the health of people living with HCV infection is to expedite the diagnosis, care, treatment, and cure of all individuals living with chronic HCV infection,” said Corinna Dan, R.N., M.P.H., Viral Hepatitis Policy Advisor, Office of HIV/AIDS and Infectious Disease Policy. “Expansion of treatment to non-specialist providers can help us do this and is much needed.”
Learn more about the National Viral Hepatitis Action Plan, a strategic framework that highlights the commitment of more than 20 federal partners working together to fight viral hepatitis in partnership with states, counties, cities and hundreds of organizations around the country.
An analysis from British Columbia, Canada shows that older people, individuals with HIV co-infection, people with cirrhosis and – to some extent – injecting drugs users have been significantly more likely to receive directly acting antiviral treatments, compared to the older interferon-based treatments. The findings show that in the current era, treatment uptake has improved for groups who tended not to receive interferon-based treatments, Naveed Janjua and colleagues write in the August issue of the Journal of Viral Hepatitis.
However individuals living in economically deprived neighbourhoods remained significantly less likely to receive treatment, although healthcare is publicly funded and free of charge to patients in British Columbia.
In the era of interferon-based treatments for hepatitis C, the rate of treatment uptake was low (below 15%) and especially so for certain population groups, including people living with HIV and people who inject drugs. Some of the barriers to treatment included increased side-effects and healthcare providers’ expectations of poor adherence. The availability of short course, highly effective and well-tolerated direct-acting antivirals (DAAs) could be expected to remove barriers and increase treatment rates.
Last week, the FDA approved AbbVie’s Mavyret—a new hepatitis C virus (HCV) drug that treats all genotypes of the disease and cures more than 90% of patients within just 8 weeks of treatment. This has been reported as a threat to Gilead Sciences’ dominant position in the market, sparking rumors of a potential price war that could lower prices on the infamously expensive treatments.
There is reason to be tentatively optimistic. The initial published price on Mavryet was lower than expected at $13,200 per month—or $26,400 for a full course of treatment—appearing on the surface to be a significant discount from the $94,500 per-treatment course costs of Harvoni, Gilead’s market-leading treatment.
And while the published price is a step in the right direction to getting more people the treatment they need, it isn’t the whole story. The set Mavryet price is reflective of the current market conditions. With behind-the-scenes payer negotiations, the announced price on Mavyret is only an approximately 15% discount to the current net price paid for Gilead’s products.
EXETER – The state Supreme Court has ruled that one of the insurance carriers for Exeter Hospital will have to cover the hospital for millions of dollars paid out to settle lawsuits stemming from the 2012 hepatitis C outbreak.
The court overturned a previous lower court decision, and found that Steadfast Insurance’s policy for the hospital had language in it that was unclear enough to warrant coverage for the hospital without the hospital spending $4 million through its self-insurance trust instead of the $1 million single-incident limit before Steadfast would defend the hospital through its umbrella coverage.
At the time of the outbreak, Steadfast provided professional liability coverage for the hospital of $1 million “per medical incident,” with a $4 million annual aggregate cap.