Hepatitis Viral

Background: New direct-acting antiviral (DAA), interferon-free, regimens for the treatment of hepatitis C became available on the Pharmaceutical Benefits Scheme on 1 March 2016. In multiphase trials, these regimens proved simpler, shorter, and highly effective with minimal side effects. Often, the efficacy and safety of the treatment conducted in real-world practice, in a population that is not as homogenous as trial populations, can differ. The aim of this prospective study is to present the initial experience, in a regional hepatitis clinic, of the implementation of PBSfunded DAA regimens in a local community. Methods: In the first 2weeks of March 2016, all patients with chronic hepatitis C infection who attended our Hepatitis Outpatient Clinic and commenced on treatment were closely followed. The Australian recommendations for the management of hepatitis C were closely followed when deciding on treatment regimen, duration, and on treatment monitoring. Drug/drug interactions were assessed for all patients. Routine follow-up, with a phone call or in clinic, by hepatology nurse or hepatologist, was organized 4–5weeks into therapy when routine bloods were checked and patients were assessed for presence and severity of side effects. Hepatitis C quantitative PCRwill be checked at the end of the treatment (EOT) and 12weeks after treatment for sustained virologic response (SVR) to assess the effectiveness of the treatment. Data for EOT, SVR, and the side effect profile will be presented. Results: We prospectively observed 103 consecutive patients in whom DAA treatment was initiated within 14 days of the release of PBS-funded therapy: 32 females (mean age 54.9 years) and 71 males (mean age 54.4 years). The great majority of patients (98%) had been assessed for presence of fibrosis with Fibroscan (88.3%) and liver biopsy (9.7%) prior to initiation of the treatment. More than half of the patients (53.4%) were treated with ledipasvir/sofosbuvir combination for genotype one infection: 21.8% of those were cirrhotic and 30.9% were treatment experienced. Low viral load and absence of cirrhosis in 13 patients (23.6%) provided an option of shorter duration of treatment for 8weeks. Six (5.8%) patients with no evidence of liver cirrhosis were commenced on treatment with ribavirin and sofosbuvir for genotype 2 infection. Daclatasvir/sofosbuvir combination for genotype 3 infection was initiated in 40.7% of patients. A considerable proportion of those patients were cirrhotic (40.4%) and onefifth were treatment experienced. Four weeks into the treatment, 47% of patients treated with ledipasvir/sofosbuvir reported mild to moderately severe adverse effects, mainly fatigue (27.2%), headache (13.4%), and nausea (9%). Unfortunately, two patients in the cohort died: suicide and aspiration after amphetamine overdose. A further patient attempted suicide but recovered and continued therapy. Patients treated with daclatasvir and sofosbuvir reported side effects less frequently: fatigue (16.6%), headache (7.1%), and nausea (4.7%). One patient required hospital admission for recurrent of pancreatitis. Conclusion: This study will provide some of the earliest real-life data from the first prospective cohort of patients exposed to the PBS-funded DAA in a regional hepatitis clinic. As with the introduction of other new hepatitis C therapies, many patients were considered difficult to treat, with many experienced to therapy and/ or having cirrhosis. In this setting, side effects remain important, and SVR for this cohort will be reported.