Enanta Pharmaceuticals Inc (ENTA)

[willyw]

The renal impairment trial results- late breaker

http://www.aasld.org/sites/default/files/LBA%20Full%20Abstracts%20Final%20%28Trimmed%29_1.pdf
(page 8)

HEPATOLOGY, VOLUME 64, NUMBER 6 (SUPPL)
AASLD ABSTRACTS
1125A
LB-11
EXPEDITION-IV: Safety and Efficacy of GLE/PIB in Adults
with renal impairment and Chronic Hepatitis C Virus
Genotype 1 – 6 Infection

" Here we report on the safety and
efficacy of GLE/PIB administered for 12 weeks in GT1-GT6
HCV-infected patients with severe renal impairment (GLE was
identified by AbbVie and Enanta).

"RESULTS:
A total of 104 partici-
pants (76% male and 62% white) were enrolled in this study,
of whom 42% were TE and 19% had compensated cirrho-
sis. Patients had either GT1 (52%), GT2 (16%), GT3 (11%),
GT4 (19%), GT5 (1%) or GT6 (1%) chronic HCV infection and
had either CKD stage 4 (13%) or stage 5 (87%); 82% were
on dialysis. SVR4 was achieved by 103/104 (99%) patients.
The patient not achieving SVR4 prematurely discontinued treat-
ment. Most treatment emergent adverse events (AEs) were mild
or moderate in severity. Of the 24% of patients who experi-
enced serious AEs, none were related to study-drug. Four AEs
(4%) led to study-drug discontinuation and one patient died
after achieving SVR4 due to a serious AE not-related to study
drug (intracerebral hemorrhage).
CONCLUSIONS
The fixed
dose combination of GLE/PIB administered once daily for 12
weeks was well tolerated in patients with severe renal impair-
ment with 99% of patients achieving SVR4. Serious AEs were
considered unrelated to study drugs and associated with the
patients’ underlying comorbidities. T"