US Veterans Affairs and Australia show potential for rapid elimination of hepatitis C

If sufficient money is available to pay for direct-acting antivirals (DAAs), the US Veterans Affairs (VA) could cure the majority of veterans under its care of hepatitis C within three years, and has already shown it has the capacity to initiate almost 7000 people on treatment in a single month, George Ioannou of University of Washington, Seattle, reported at the 2016 AASLD Liver Meeting in Boston on Monday.

Data from Australia presented at the conference showed what happens when another big health system begins scaling up treatment. Since March 2016, 26,000 people are estimated to have begun DAA treatment in Australia, research carried out by researchers at the Kirby Institute, University of New South Wales, indicates.

The US Veterans Affairs Administration is the largest provider of hepatitis C care in the United States. Approximately 174,000 veterans who receive care through its clinics had been diagnosed with chronic hepatitis C virus (HCV) infection by 2013 and a further 45,000 were estimated to be undiagnosed. As part of a larger analysis of treatment patterns within the VA system, George Ioannou and colleagues examined the annual uptake of treatment. They found that 57,445 people have been cured of HCV in the VA system since 1999. Almost half of these patients – 28,084 – were cured in 2015, and almost half of all people cured in the VA system in 2015 began treatment in August and September of that year.

The reason for the sudden explosion in treatment numbers was a Congressional decision to approve $500 million in funding for hepatitis C treatment for the VA system, on condition that the money was spent in August and September 2015. This decision resulted in a jump in treatment initiations, from less than 1000 in July 2015 to over 4000 in August 2015 and almost 7000 in September 2015. Treatment numbers fell back after September 2015, but in 2016 restrictions on who can be treated were lifted after the cost of medication fell and funding for hepatitis C treatment was doubled. The investigators estimate that it will be possible to treat at least half the remaining 124,000 people with hepatitis C in the next three years if funding remains stable, achieving cure rates above 90% for genotype 1 infection.

At the beginning of 2016 the Australian government announced that it would fund DAA treatment for anyone with hepatitis C, regardless of liver disease stage. The decision followed extensive campaigning by patient groups and negotiations with the pharmaceutical industry that resulted in an innovative pricing agreement. In return for committing to spend $1 billion on DAAs over three years, manufacturers agreed to provide treatment for that sum to everyone who sought treatment during that period.

Liver specialists and patient groups expected high demand, reflecting years of pent-up demand for treatment in Australia, but the pace of uptake has surprised everyone. In a poster presentation at The Liver Meeting, Behzad Hajarizadeh and colleagues at the Kirby Institute presented estimates of treatment uptake during the first five months of availability of DAAs through Australia’s Pharmaceutical Benefits Scheme (PBS), which covers almost all the cost of prescribed medicines for Australian citizens.

Data were gathered from PBS records and wholesale drug expenditure figures, and used to estimate the number of people starting treatment and the distribution of treated people across Australian states. The study also looked at which types of prescribers were initiating people on treatment.

As its baseline, the study assumed that around 227,000 people were living with diagnosed HCV in March 2016. Analysis of the PBS records found that 18,581 people started treatment during the first five months of DAA availability, but due to the time lag between prescription filling and processing of the claim by the PBS, the number who started treatment was much higher. Analysing the amount of money spent on medication led the researchers to estimate that around 26,000 had begun treatment during the 5-month period (although this figure could be as high as 30,415 or as low as 22,304).

In March and April 2016 around 7000 people in each month started treatment. In subsequent months the numbers starting treatment fell below 4000 per month. The researchers estimate that around 12% of people with hepatitis C had begun treatment by the end of July 2015, although the proportion treated appears lower in Western Australia (7%) and Northern Territory (8%).

Fifty-eight per cent of people started treatment with sofosbuvir/ledipasvir (Harvoni), and in the vast majority of cases this was a 12-week treatment course. Sofosbuvir/daclatasvir was prescribed in 38% of cases. Paritaprevir/ritonavir/ombitasvir and dasabuvir (Viekirax) was prescribed to only 1% of people.   

Taking into account people previously treated through clinical trials or early access programmes, and those who obtained generics, the researchers estimate that two-thirds of people with cirrhosis have already begun treatment, the vast majority since March 2016.