Study Supports Minimal Monitoring in Sofosbuvir-Based Therapy for HCV

Some patients receiving sofosbuvir-based therapy for hepatitis C virus (HCV) may not need standard monitoring with clinic visits and blood testing, according to a new study that showed minimal monitoring resulted in equal cure rates at less cost.

The study, published in Open Forum Infectious Diseases, evaluated virological response, staff time and patient satisfaction among patients receiving minimal monitoring, which included a phone call at treatment weeks 4 and 12, along with 1 set of blood tests and a clinic visit 12 weeks after completion. The results were compared with standard monitoring, which included blood tests and clinic visits at 4, 12 and 12 weeks after completion.

The randomized controlled trial included 74 patients receiving oral direct acting antiviral agents (DAA) at 2 Australian teaching hospitals enrolled in the study between December 2016 and December 2017.

“Uncomplicated patients being treated with oral DAA regimens for HCV only require minimal monitoring, with routine clinic visits and blood tests only needed at baseline and 3 months after the end of treatment,” Josh Davis, MBBS, FRACP, DTM&H, GCPopHealth, PhD, of the Menzies School of Health Research told Contagion^®.

The study included 36 patients who received standard monitoring and 38 who received minimal monitoring.

Sustained virologic response (SVR) tests after 12 weeks of treatment (SVR12) showed no significant differences between the group that received minimal monitoring (97% [95% CI, 86%—100%]) and those who received standard monitoring (89% [95% CI, 74%–97%]) when those with missing SVR data were assumed to be failures. All patients in both groups achieved SVR12 when those with missing SVR data were disregarded.

Staff time and patient satisfaction also were similar in both groups. Total staff time was reduced by 17 minutes—69 minutes in the standard monitoring group compared with 52 minutes in the minimal monitoring group. Overall patient satisfaction scores on a 10-point Likert scale were 9.8 in the standard monitoring group and 9.6 in the minimal monitoring group.

There were no significant differences in adverse events between the two groups. The total cost of blood tests averaged $432 in the standard monitoring group compared with $123 in the minimal monitoring group.

Standard monitoring may be necessary for some patients whose cases are more complicated.

“These results don’t apply to complex patients including those with current substance use disorders, active mental illness or decompensated cirrhosis—these patients likely need closer monitoring,” Davis told Contagion^®.

He said decisions should be made on a case-by-case basis.

“Clinics and primary care practitioners who treat HCV patients should stop doing routine on-treatment blood tests and/or clinic visits, and make individualized monitoring plans for each patient,” Davis told Contagion^®.

The research ended up supporting shifts in clinical practice that began before the study’s completion, so further research to confirm the results is unlikely.

“There was a drift in clinical practice during the course of the trial, so that many clinicians, and even guidelines, changed to recommending minimal monitoring, in advance of the evidence!” Davis told Contagion^®.

The incidence of HCV has risen during the past decade and causes about 20,000 deaths annually in the United States. To increase the number of people infected with HCV who receive antiviral therapy, a recent study examined shifting care from specialists to primary care professionals. The study found that community-based treatment of uncomplicated HCV improved treatment uptake and cure.

The high cost of drugs has been 1 factor limiting access to treatment. A study published last year found that patients who received DAA treatment had significantly lower overall medical costs than untreated patients.