A randomised controlled trial of standard versus minimal monitoring during hepatitis C treatment has confirmed that clinical outcomes, patient satisfaction and adherence are similar in both groups.
The findings, from trial sites at John Hunter Hospital and Royal Darwin Hospital, support an upcoming consensus statement recommendation for minimal monitoring.
Conjoint Professor Joshua Davis from John Hunter Hospital told the Australasian Society for Infectious Diseases (ASID) Annual Scientific Meeting that direct-acting antivirals had changed the treatment landscape for patients and clinical staff.
“Interferon-based treatment had lots of side effects so patients needed face-to-face monitoring and blood tests; the nursing and medical staff were used to having people coming in all the time.”
“So now hospital specialists are playing less of a role, nurses are playing less of a role and GPs much more of a role. People are repurposing their roles and have got used to new ways of doing this although there are still some adjustments being made to workflows.”
The SIMPLICITY study included mostly treatment-naive patients with either HCV genotype 1 or 3 given a relevant sofosbuvir-based treatment but excluding patients with more severe or complex disease such as cirrhosis.
Standard monitoring included face-to-face visits and blood tests such as FBC, urea and electrolytes, LFTs and HCV PCR at baseline, week 4, week 12 and again 12 weeks later.
Minimal monitoring included a face-to-face appointment at baseline, phone calls only at weeks 4 and 12 and a ‘test of cure’ face-to-face visit with blood tests 12 weeks later.
Professor Davis said cure rates were 100% in both groups and adverse events were similar – 44% in the standard and 47% in the minimal monitoring group. There were no serious adverse events in either group.
There was also no statistically significant difference between the groups in unplanned visits to GPs or EDs (11 v 16%) or unplanned investigations (3 versus 0%).
Adherence was higher with standard versus minimal monitoring (97 v 86%) but not statistically different.
“There was a trend towards less patients being 100% adherent with minimal monitoring, which is a potential concern, but probably they don’t need 100% adherence,” Professor Davis told the meeting.
Patient satisfaction with their level of care was high in both groups (9.8 v 9.6 out of 10).
The study found the total number of hours staff spent in contact with patients was not significantly different – 69 minutes with standard versus 52 minutes with minimal monitoring.
However the cost of tests was significantly lower in the minimal monitoring group ($431 v $123).
Professor Davis said the selected population meant the findings were probably not generalisable to all patients with hepatitis C.
“I don’t think anyone would have equipoise to enrol those more complex patients. We all feel that complex advanced liver disease patients need blood test monitoring on therapy because sometimes their cirrhosis decompensates. It might be because of therapy or it might be a coincidence but we wouldn’t leave someone for three months without blood tests.”
However for most patients, minimal monitoring was the new standard of care.
“It’s well accepted now that we have realised that these drugs are so easy to use and so safe – and the reason guidelines have changed.”