Serious adverse events occurred in 12 ( 6 % ) patients in the treatment-naive group ; 11 ( 5 % ) non-responders , and 16 ( 7 % ) ineligible , intolerant , or ineligible and intolerant patients ; adverse events leading to discontinuation ( most commonly reversible increases in alanine or aspartate aminotransferase ) occurred in six ( 3 % ) , two ( 1 % ) , and two ( 1 % ) patients , respectively , with no deaths recorded .