PBS listing for primary biliary cholangitis treatment

Obeticholic acid (Ocaliva) has been listed on the PBS from 1 September for the treatment of primary biliary cholangitis.

The drug was registered by the TGA in 2018 for ‘the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.

A rare condition, primary biliary cholangitis is 10 time more common in women than men and there is currently no cure, though treatment can help slow the progression of the disease and ease symptoms.

The PBAC considered an application for listing in 2020 and noted the clinical claim that obeticholic acid plus UDCA was superior to UDCA alone in reducing alkaline phosphatase and bilirubin levels and other important clinically relevant endpoints.

Without PBS subsidy, around 890 Australians per year might pay more than $60,500 per course of treatment.

Seronegative coeliac disease more aggressive: study

Seronegative coeliac disease has a more aggressive disease phenotype than seropositive coeliac disease, according to international researchers who followed up a cohort of patients for more than two decades.

In their investigation of 227 patients previously diagnosed with seronegative coeliac disease, they found that true seronegative coeliac disease was confirmed in 84, coeliac disease+IgAd in 48, and excluded in 55.

Compared to a control group of 2084 patients with seropositive coeliac disease, true seronegative coeliac disease had more severe symptoms at diagnosis and a 11-fold higher risk of complications and higher mortality rates (HR 2.18, 95% CI 1.12-4.26, P < 0.01) than seropositive coeliac disease.

There were no differences between true seronegative coeliac disease and coeliac disease+IgAd.

Age at diagnosis, lack of clinical response to a gluten free diet (GFD), true seronegative coeliac disease, coeliac disease+IgAd, and classical presentation predicted complications.

The researchers said the data “would argue against over-reliance on coeliac serology for the diagnosis of coeliac disease and strongly support the need of assessing histological response to a GFD in patients with seronegative coeliac disease. “

The findings are published in Alimentary Pharmacology and Therapeutics.

Doctors hit the bottle to relieve pandemic distress

Alcohol is one of the main coping strategies used by Australian healthcare workers in response to the pandemic, a national survey has revealed.

Conducted in September 2020, the survey on wellbeing and coping strategies elicited responses from 7846 frontline healthcare workers including more than 2400 medical staff, and showed that over a quarter (26.3%) reported increased alcohol use.

The most commonly reported adaptive coping strategies were exercise (45%), social connections (32%) and yoga or meditation (26%), whereas few used workplace support programs (6%) or sought help from a doctor or psychologist (18%).

Use of alcohol was associated with poor mental health and worse personal relationships, the study found.

The study investigators said the widespread use of maladaptive coping strategies by healthcare workers during the second wave highlighted an urgent need to improve access and uptake of professional support services for psychological distress.

Read more in General Hospital Psychiatry