The introduction of direct-acting antiviral therapy in 2013 led to a significant increase in the number of veterans treated for hepatitis C and in the sustained virologic responses achieved, according to a review of the Veteran Affairs Corporate Data Warehouse records.
“Several factors likely contributed to the remarkable increases in HCV treatment and cure rates that occurred in 2014 and 2015,” Andrew M. Moon, MD, MPH, of the Divisions of General Internal Medicine, University of Washington, and colleagues wrote. “Most importantly, the introduction of interferon-free DAAs vastly increased the VA population eligible for and willing to undergo antiviral treatment. Second, given the high relative cost of DAAs, increases in the VA funding were critical. Third, the VA embraced innovative care models including the use of teleconsultation for HCV treatment.”
The review data included 105,369 HCV antiviral regimens among 78,947 patients initiated in the VA between Jan. 1, 1999, and Dec. 31, 2015. The mean patient age was 56.2 years, most patients were men (96.8%) and white (61.7%) or black (29.3%). Patients had genotype 1 (79.2%), 2 (12%), 3 (8%) or 4 (0.8%). Pre-treatment liver-related comorbidities included cirrhosis (21.5%), decompensated cirrhosis (6.6%) or hepatocellular carcinoma (1.7%).
The researchers modelled the annual treatment rates and SVR rates into time periods that reflected the introduction and use of new therapies: pegylated-interferon from 2002 to 2010; Victrelis (boceprevir, Merck) and Incivek (telaprevir, Vertex) from 2011 to 2013; Sovaldi (sofosbuvir, Gilead Sciences) and Olysio (simeprevir, Janssen Pharmaceuticals) in 2014; and Harvoni (ledipasvir/sofosbuvir, Gilead Sciences) and Viekira Pak (paritaprevir/ritonavir/ombitasvir/dasabuvir, AbbVie) in 2015.
Annual treatment rates grew from 2,726 in 2001 to 6,679 in 2002 with a steady decline until 2010. Rates increased again to 4,900 in 2012, but declined to 2,609 in 2013. By 2014, the rates increased to 9,180 and then to 31,028 in 2015.
Annual SVRs (observed or imputed) increased from 618 to 2,204 in the 2001 to 2010 era, to 1,273 to 2,296 in the 2011 to 2013 era, to 7,377 in 2014 era, to 28,084 in the 2015 era, and the number of patients cured in 2015 represented nearly half of the 57,445 patients cured over the 17-year review period.
“As of February 2016, the VA removed all HCV treatment prioritization criteria and encouraged treatment of all patients, whilst continuing to emphasize aggressive outreach to patients with advanced fibrosis or cirrhosis. This should further increase treatment rates and is in stark contrast to most health care systems, state Medicaid programs and insurance carriers in the U.S., which still restrict access to DAAs based on severity of liver disease,” the researchers wrote. “Following the VA’s lead, state Medicaid programs in New York, Washington, Delaware, Florida and Massachusetts announced the removed restrictions on the coverage of DAAs.”
On Jul. 31, 2015, the U.S. Congress passed the Surface Transportation and Veterans Health Choice Improvement Act, which provided $500 million in “unrestricted” funding to complement the VA’s October 2014-September 2015 fiscal year allocation of $696 million for DAAs. Following this, monthly treatment rates increased from 762 in July to 4,416 in August and 6,959 in September 2015.
The researchers believe that with increased funding and reduced costs of DAAs, the VA can successfully treat most of the remaining 124,662 veterans with HCV in VA care within the next few years. – by Talitha Bennett
: The researchers report no relevant financial disclosures.