T12/PR24 n=80 | T12/PR48 n=35 | Unassigned n=2* | |
Overall: n, % | 47 (59) | 18 (52) | 2 (100) |
Prior null responders: n/N, % | 3/23 (13) | 16/28 (57) | – |
Prior partial responders: n/N, % | 15/25 (60) | 0/3 (0) | 1/1 (100) |
Prior relapsers: n/N, % | 23/25 (92) | 2/3 (67) | 1/1 (100) |
Prior viral breakthrough: n/N,% | 6/7 (86) | 0/1 (0) | – |
↵* One prior partial responder and one prior relapser who discontinued all treatment prior to reaching week 12 of dosing were designated “unassigned” to treatment group.
The most frequent AEs (=20%) were fatigue, flu-like-syndrome, nausea, diarrhoea, pruritus, rash, headache, insomnia and anaemia. Grade 3 rash and Grade 3 anaemia were observed in 6 (5%) and 6 (5%) patients, respectively. Ten (9%) patients discontinued due to AEs, 5 (4%) due to rash and 2 (2%) to anaemia.