The first real-world results for direct-acting antiviral (DAA) treatment of hepatitis C in Australia show efficacy rates are on par with clinical trials but almost one in seven patients are being lost to follow-up.
Between March 2016 and March 2017, gastroenterologist and hepatologist Dr James Haridy and colleagues in South Australia followed up 1909 patients with chronic hepatitis C infection who initiated antiviral treatment at four tertiary centres in the state.
Their findings, which represent the first and largest outcome data from a setting of unrestricted access to multiple DAA regimes in the world, found 80.4% of patients intended for DAA treatment (1534) achieved confirmed sustained virological response (SRV12). But 272 patients – 14.2% – were lost to follow-up, while a further 34 patients did not complete treatment for a variety of reasons, including mortality.
The majority of patients were infected with genotype 1 (43% 1a; 9.2% 1b; 4.3% 1 non subtype) and genotype 3 (38.2%) while lesser numbers were treated for genotype 2 (3.5%) genotype 4 (1%) and genotype 6 (0.3%) and 25.5% of patients were cirrhotic.
A total of 80.3% of treatment was initiated in hospital, 4.8% in the prison system and 19.7% was carried out by non-specialists in the community via remote consultation with specialists.
The most common treatment for genotype 1 patients with or without cirrhosis and genotype 2 patients was sofosbuvir/ledipasvir. Genotype 3 patients given sofosbuvir/daclarasvir, and in a small proportion of those with cirrhosis ribavirin was added.
The findings confirmed the “chasm” that exists between efficacy and effectiveness in HCV treatment in the DAA era, writes Dr Haridy, now working at the University of Melbourne, in the Journal of Viral Hepatitis.
“While DAA therapy is proven highly efficacious in both trial and real world settings, the overall effectiveness of an elimination program will in part depend on adequate delivery and follow up,” he wrote
The study identified high rates of lost to follow up (LTFU) in younger patients (median 50 years vs 54 years) and those treated in the community or prison. And while some of them may have achieved SVR12 there was no way of knowing for certain.
Individualised treatment adherence plans have helped curb loss to follow-up rates in traditionally difficult highly marginalised patient groups, “suggesting the benefit of placing more viral hepatitis clinical nurse specialists in the hospital setting and/or more intensive community support in DAA treatment may be a defining factor in maintaining adherence to follow up schedules and SRV12 testing”.
Tracking patients treated in the community has many challenges, Dr Haridy told the limbic.
“But it can be done. Dr Phillip Read ( from the Kirby Institute in Sydney) treats some of the most highly marginalised populations and his loss to follow up is almost the same as our hospital lost to follow-up rate in SA. He did that with a significant adherence program, where he had essentially a nurse chasing up patients to ensure they came back for their blood test. He’s shown it can be done with a bit more support. That’s where having viral hepatitis nurses in the community is important.
“Electronic alerts on GP files are also shown to work, and we’re trying newer online systems where patients can log on, but we don’t have any data yet.”
“The main message out of the study is that the treatment is highly effective, but supporting GPs for treatment and follow up by the whole specialist team, including viral hepatitis nurses, to help follow up patients, is essential going forward.”
An even more pressing question that became apparent in the latter part of the study is how to reverse declining treatment initiation rates after motivated early-adopters have been treated, Dr Haridy said.
“That’s going to become the bigger issue for Australia going forward, and (the solution) is the million dollar question which everyone is asking,” he asaid.
“Certainly I think screening and finding these patients. A lot of GPs around the country say ‘I don’t have any hepatitis C patients, that’s just simply not true when we look at the statistics.
“The second issue is reaching the highest risk populations, there’s large reservoirs of hep C in injecting drug users, the homeless, mental health and you need a lot of resources to link these people to care and keep them engaged and I think that’s the other thing really lacking at the moment, taking the treatment out to where people are in the community.”
Australia is one of just 12 countries on track to eliminate hepatitis C by 2030, according to new data presented at the recent Global Hepatitis Summit in Toronto.
Only countries with unrestricted access are eligible for the list, which is prepared by the Polaris Observatory run by the CDA Foundation.