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 1 Components of each shortening strategy and cost differences compared with standard 12-week treatment

Shortening strategy	Resource use of providing treatment				Difference in cost compared with standard 12-week treatment
Shortening strategy	Mean weeks of DAA	Number of PEG-IFN injections	Number of visits required	Number of VL tests	Difference in cost compared with standard 12-week treatment
Standard 12-week treatment	12	0	3^a	1^a	–
PEG-IFN + DAA (4 weeks’ treatment, weekly PEG-IFN)	4	4	6	1	-8x(weekly drug cost) + 4x(interferon cost) + 3x(visit cost)
Response-guided therapy (4, 8, or 12 weeks’ treatment)	9.6^b	0	4	2	−3.4x(weekly drug cost) + 1x(visit cost) +1x(VL cost)
Induction/maintenance (7 days/week for 2 weeks, then 5 days/week)	9.14	0	4^c	1	−3.86x(weekly drug cost) + 1x(visit cost)

Abbreviations: DAA direct-acting antiviral, PEG-IFN pegylated-interferon, VL viral load.
^a Assuming minimum visits at treatment initiation, end of treatment, end of treatment plus 12 weeks (where VL is done once to assess cure)
^b Assuming 1:3:1 receiving 4:8:12 weeks of treatment. One extra visit and VL at day 7 to assess initial VL response
^c Assuming one extra visit at week 2 when move from induction to maintenance phase

ISSN: 1745-6215