Abstract
Background: Oral direct acting antiviral agents (DAAs) for hepatitis C virus (HCV) became government subsidised in Australia in March 2016, bringing the interferon era to a close. The ideal monitoring schedule for patients receiving DAAs is unclear.
Methods: Randomized controlled trial, comparing standard with minimal monitoring in adults receiving sofosbuvir-based therapy for HCV genotypes 1 or 3. Exclusion criteria were cirrhosis, or predicted poor adherence. Standard monitoring included blood tests and face to face clinic visits at treatment weeks 4 and 12, and 12 weeks after treatment completion. Minimal monitoring included a phone call at weeks 4 and 12 and one set of blood tests plus a clinic visit 12 weeks after treatment completion. The co-primary outcomes were: i) Proportion of participants with sustained virological response; ii) Staff time spent on patient support; and iii) Patient satisfaction on a 10-point Likert scale.
Results: 36 patients were randomized to standard and 38 to minimal monitoring. SVR12 was documented in 32/36 (89%) in the standard versus 37/38 (97%) in the minimal monitoring group. Staff time was non-significantly longer in the standard group (median [IQR] 69 [54-80] versus 52 [40-75] minutes). Patient satisfaction scores did not differ (mean 9.8/10 standard versus 9.6/10 minimal group). There was no difference in adverse events or unplanned hospital visits; mean per-patient blood test costs were higher in the standard monitoring group (A$432 versus a$123, p<0.001).
Conclusion: On treatment monitoring with blood tests and clinic visits may not be necessary during sofosbuvir-based HCV treatment in selected patients.
Methods: Randomized controlled trial, comparing standard with minimal monitoring in adults receiving sofosbuvir-based therapy for HCV genotypes 1 or 3. Exclusion criteria were cirrhosis, or predicted poor adherence. Standard monitoring included blood tests and face to face clinic visits at treatment weeks 4 and 12, and 12 weeks after treatment completion. Minimal monitoring included a phone call at weeks 4 and 12 and one set of blood tests plus a clinic visit 12 weeks after treatment completion. The co-primary outcomes were: i) Proportion of participants with sustained virological response; ii) Staff time spent on patient support; and iii) Patient satisfaction on a 10-point Likert scale.
Results: 36 patients were randomized to standard and 38 to minimal monitoring. SVR12 was documented in 32/36 (89%) in the standard versus 37/38 (97%) in the minimal monitoring group. Staff time was non-significantly longer in the standard group (median [IQR] 69 [54-80] versus 52 [40-75] minutes). Patient satisfaction scores did not differ (mean 9.8/10 standard versus 9.6/10 minimal group). There was no difference in adverse events or unplanned hospital visits; mean per-patient blood test costs were higher in the standard monitoring group (A$432 versus a$123, p<0.001).
Conclusion: On treatment monitoring with blood tests and clinic visits may not be necessary during sofosbuvir-based HCV treatment in selected patients.
| Original language | English |
|---|---|
| Article number | ofaa022 |
| Pages (from-to) | 1-7 |
| Number of pages | 7 |
| Journal | Open Forum Infectious Diseases |
| Volume | 7 |
| Issue number | 2 |
| DOIs | |
| Publication status | Published - Feb 2020 |