Theme: Clinical Research Year: 2019
Background: Certain population groups are at higher risk for hepatitis C virus (HCV) infection; they
are classified as core transmitters (CT) and include people who inject drugs (PWID), and men who
have sex with men (MSM). This 2
nd planned interim analysis aimed to describe the patient/disease
profile of HCV-infected core transmitters (CT) and non-CTs treated with direct-acting antivirals
(DAAs) during routine clinical care in Canada and compare rates of treatment failure and sustained
virologic response (SVR).
Methods: C-RESPECT is an ongoing, prospective, observational study of HCV-infected (genotypes 1,
3, and 4) patients treated with DAAs. After baseline, visits are recommended at end of treatment
(EOT), every 3 months post-EOT for assessment of SVR at 12 and 24 weeks, and every 6 months
thereafter as per clinical practice. Treatment failure is defined as detectable HCV RNA on or after
EOT. Eligible patients enrolled between March 2017-December 2018 were assessed.
Results: A total of 350 patients (207 CT/143 non-CT) were included. Statistically significant (p<0.05) differences in baseline parameters were observed between CT and non-CT patients, including age, race, employment, housing and economic status, smoking and illicit drug use, genotype, BMI, incarceration history, and fatigue severity. Overall, 170 patients completed their DAA treatment (94 CT and 76 non-CT), for which detectable HCV RNA was observed in 9.6% and 5.3%, respectively (p=0.201201). Achievement of SVR12 (95.8% CT vs. 94.1% non-CT) was not statistically different (p>0.05) between groups. Treatment failure incidence density rates (IDR), per 100 person-years (PY)
of follow-up, were also comparable for CT vs. non-CT patients [IDR (95%CI): 23.8/100PY (133.5-
4242.0) vs. 18.0/100PY (8.6- 377.8)].
Conclusion: The profile of CT and non-CT HCV-infected patients differs significantly at DAA initiation,
however both groups demonstrate comparable rates of treatment failure and SVR. Future analyses
will focus on incidence and predictors of HCV re-infection post-DAA treatment.
Disclosure of Interest Statement: This study was sponsored by Merck Sharp & Dohme Corp.,
Whitehouse Station, NJ, USA and sponsored and funded by Merck Canada Inc., Kirkland, Qc, Canada.
BC reports grants/honoria from AbbVie, Gilead, Merck. DS reports Advisory board fees from AbbVie,
Merck, Gilead; research fees from Merck, Gilead. RT reports consulting fees from AbbVie, Gilead,
Merck, and ViiV. AW reports reports grants/personal fees from Merck, Gilead, AbbVie. GS reports
speaker/advisory board member fees from Merck, Gilead; speaker fees from AbbVie; unrestricted
research funds from Merck. CC reports reports grants/personal fees/non-financial support from
Merck, Gilead, AbbVie. HS reports conflicts of interest from AbbVie, Intercept, Gilead, Merck, BMS.
EB reports to be employed by Merck Canada Inc. RNK reports to be employed by Merck Sharp &
Dohme Corp. EGW reports to be employed by Merck Canada Inc.