December 8, 2016
George Ioannou, M.D., M.S., presenting study results (Credit: Warren Tong)
The U.S. Department of Veterans Affairs (VA) estimates that it can treat and cure most of the remaining 124,000 patients living with hepatitis C (HCV) in VA care within the next three years, after a record year of treatment and cures in 2015, according to a study presented at the Liver Meeting 2016, in Boston.
The Veterans Health Administration, which is part of the VA, is the largest integrated health care system in the U.S., with 168 medical centers and 1,053 outpatient care sites. In 2013, there were approximately 5.7 million veterans in VA care. Of those, about 3% (174,000) were diagnosed with HCV and an estimated 0.8% (45,000) were undiagnosed.
The study, which was presented by George Ioannou, M.D., M.S., analyzed data on treatment and cure rates for those individuals diagnosed with HCV in VA care over a period of 17 years between 1999 to 2015. During this period, there were about 105,000 antiviral regimens used on 79,000 patients (with some patients needing more than one regimen).
Of these patients, 80% had HCV genotype 1, 12% had genotype 2, 8% had genotype 3 and 0.8% had genotype 4. About 62% were white, 29% were African American and 7% were Hispanic. The mean age was 56.2 years and about 21% had cirrhosis. Both the average age and the proportion of patients with cirrhosis steadily increased during the study period, Ioannou pointed out.
About 57,000 patients achieved sustained virologic response (SVR), or cure, over the 17-year study period. Notably, about half (28,084) of these were cured in a single year: 2015. Part of the reason for this was the introduction of newer direct-acting antivirals (DAAs) that can cure HCV in eight weeks, even for tougher-to-treat patients.
Significantly, in 2015 the VA received additional unrestricted funding of $500 million for DAAs that it had to use over two months. For context, at the beginning of 2015, the VA was allotted $750 million total budget for DAAs. However, the medications were so expensive that halfway into the fiscal year a lot of facilities ran out of money, resulting in a dramatic decline in treatment rates to almost nothing in July 2015, according to Ioannou. But, that same month, Congress passed the Surface Transportation and Veterans Health Care Choice Improvement Act, which allocated the aforementioned $500 million in additional funds for HCV treatment in Aug. and Sept. 2015 (the end of the fiscal year).
"It was basically 'use it or lose it.' During those two months, essentially the VA had unrestricted, unlimited access to money for antiviral medications. And we wanted to see what could happen in a national health care system when money is not a problem," Ioannou said. In those two months, there was a record treatment rate, with almost 7,000 patients treated in Sept. 2015 alone, which was more than the total number in any year before that.
Further looking into the treatment numbers and cure rates, the VA found that from 2010 (the last year of the interferon era) to 2015 the annual number of patients treated increased 8.5 fold (from 3,646 to 31,028). At the same time, the annual number of patients cured increased 21 fold (from 1,313 to 28,084) and the SVR percentage (the proportion of treated patients who were cured) increased 2.5 fold (36% to 90.5%).
Even though a record number of VA patients were treated and cured in 2015, the limited availability of funds for DAAs at the beginning of the year coupled with the high cost of DAAs restricted the VA's ability to treat even more patients, Ioannou noted.
The VA is expecting to continue this impressive trend, with 2016 looking to be an even better year than 2015 in terms of treatment and cure rates. Relative to 2015, the funds for DAAs have doubled and the cost of DAAs in the VA system has reduced by half, Ioannou revealed. Moreover, the VA removed all treatment restrictions (such as patient eligibility and prioritization), so now any patient can be treated.
At the beginning of 2015, there were about 124,662 HCV-positive patients left in VA care. At the current and expected treatment rates, the VA has the capacity to treat and cure the majority of these patients within the next three years, Ioannou said.
"For hepatitis C eradication to become a reality in the whole country, two things need to occur. First, other federal and non-federal third-party payers need to provide unrestricted access to DAAs. Second, the cost of DAAs needs to be substantially reduced," Ioannou concluded, according to the study press release.
Warren Tong is the senior science editor for TheBody.com and TheBodyPRO.com.
Follow Warren on Twitter: @WarrenAtTheBody.
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