The design and statistical aspects of VIETNARMS: a strategic post-licensing trial of multiple oral direct-acting antiviral hepatitis C treatment strategies in Vietnam

Table 4 Timing of interim analyses

	First	Second	Third	Fourth
Months since recruitment started	7	10	13	18
Total recruited	205	361	517	777
Total at EOT + 12 weeks	44	144	286	533
At EOT + 12 weeks in each:
PEG-IFN group	5	14	24	42
RGT group	3	11	21	39
Induction/maintenance group	2	8	17	35
Average probability genuinely inferior group will be stopped^a
PEG-IFN groups	0.124	0.297	0.537	0.710
RGT groups	0.021	0.313	0.440	0.665
Induction/maintenance groups	0.070	0.150	0.431	0.593

Abbreviations: EOT + 12 12 weeks after the end of treatment, PEG-IFN pegylated-interferon, RGT response-guided therapy
^a Assuming true cure rate uniformly distributed over 60–90%

ISSN: 1745-6215