Article Text
Abstract
Background and importance The new direct acting antivirals (DAAs), indicated in chronic hepatitis C (HCV), show a sustained virological response at 12 weeks (SVR12) >90% in clinical trials, with worse results in patients with genotype 3.
Aim and objectives To analyse the effectiveness of the new DAAs in a real cohort of HCV patients during 2018, and establish if there are differences between genotypes.
Material and methods This was a retrospective observational study including all patients treated with DAAs in 2018. The variables collected were: age, sex, HCV/HIV coinfection, genotype (G), degree of fibrosis (F), previous treatments, basal viral load (BVL), treatment duration, viral load at 12 weeks post-treatment, adherence and adverse effects (AEs). Effectiveness was evaluated according to SVR12.
Results Ninety-one patients (57.1% men) received treatment with DAAs, with a mean age of 55.6±10.4 years; 20 (22%) were coinfected with HIV, and 55 (60,4%) had BVL >800 000 UI/mL. The genotype distribution was: 29 (31.9%) G1a, 28 (30.8%) G1b, 1 (1.1%) G2, 15 (16.5%) G3 and 18 (19.8%) G4. Degree of fibrosis: 27 F0–F1, 16 F1, 10 F2, 15 F3, 2 F3–F4 and 14 F4; 7 (7.7%) patients were without data (WD). There were 75 (82.4%) naive patients; 6 had received treatment with DAAs (2 with two different lines).
Treatment distribution was: 36 (39.6%) glecaprevir/pibrentasvir, 28 for 8 weeks and 8 for 12 weeks; 29 (31.9%) elbasvir/grazoprevir, 28 for 12 weeks and 1 for 16 weeks; 23 (25.3%) sofosbuvir/velpatasvir for 2 weeks, 2 with ribavirin; 1 (1.1%) ledipasvir/sofosbuvir for 8 weeks; 2 (2.2%) sofosbuvir/velpatasvir/voxilaprevir for 12 weeks, both after relapse to two previous lines with DAAs.
The response observed was: glecaprevir/pibrentasvir 32 SVR12, 3 WD and 1 treatment suspension because of the patient‘s poor clinical condition; elbasvir/grazoprevir 26 SVR12 and 3 WD; sofosbuvir/velpatasvir 17 SVR12, 3 WD, 1 died (sepsis) and 2 virological failure (VF) (both G3, 1 F3, 1 F4, 1 relapsed to DAAs); ledipasvir/sofosbuvir: 1 SRV12; sofosbuvir/velpatasvir/voxilaprevir 2 SRV12. Of the total evaluable responses (n=80), 78 (97.5%) SRV12 and 2 (2.5%) VF were observed.
Conclusion and relevance Our data confirm the effectiveness of the new DAAs, with SVR12 >95%, and are consistent with clinical trials which show that patients with G3 have the worst SVR12 rates.
References and/or acknowledgements No conflict of interest.