Theme: Clinical Research Year: 2019
Background: In Slovenia, a significant proportion of patients treated for hepatitis C virus (HCV)
infection represent people who inject drugs (PWID). The second generation of direct-acting antivirals
(DAAs) for the treatment of HCV infection are routinely used since January 2015. The aim of the
study was to compare sustained virological response (SVR) in real-life setting between PWID and
non-PWID at a national level.
Methods: All HCV-infected patients from Slovenia who initiated DAAs (simeprevir, sofosbuvir,
paritaprevir/ombitasvir±dasabuvir, sofosbuvir/ledipasvir, elbasvir/grazoprevir, and
sofosbuvir/velpatasvir) between January 2015 and December 2017 were included prospectively on
intention to treat (ITT) and modified ITT (mITT) analyses. Demographic, epidemiological, virological
and clinical data were collected from all settings providing HCV treatment in Slovenia.
Results: Overall 400 patients were included, 176 (44%) were PWID. Average age was significantly
lower in PWID (44 years), compared to non-PWID (56 years) (CI=99%, p=0,001). There were
significantly more males among PWID (82%) compared to non-PWID (50%) (CI=99%, p<0,001).
Comparing PWID and non-PWID, fibrosis stages F3 and F4 were reported in 24% vs. 26%, and 46%
vs. 42%, respectively, with no significant differences. Genotype 1 was significantly more common in
non-PWID (84%) (CI=99, p<0,001) and genotype 3 was significantly more common in PWID (42%)
(CI=99, p<0,001). 78% of PWID and 55% of non-PWID were treatment naïve, the difference being
significant (CI=99, p<0,001). SVR rate in ITT analysis was significantly higher in non-PWID (95%)
compared to PWID (85%) (CI=99%, p=0,001). Nine PWID discontinued treatment for unknown
reasons and 10 failed 12-week follow-up (FU12) after end-of-treatment response. In mITT analysis,
SVR was achieved in 149/153 (97%) of PWID and in 213/219 (97%) of non-PWID.
Conclusions: The results in real-life setting show higher SVR rates of DAAs in non-PWID compared to
PWID. However, excluding those with premature treatment discontinuation for unknown reasons
and those who failed FU12, SVR rates were the same for both groups.
Disclosure of interest: none