Retreatment of hepatitis C — sofosbuvir/velpatasvir/ voxilaprevir (SOF/VEL/VOX) 2

All consecutive patients receiving SOF/VEL/VOX in 27 centers
in northern Italy from May – October 2018 were enrolled in a
real life study. A total of 179 patients with previous failure to
DAAs were included. 77/179 (44 %) had cirrhosis and 76 of the
77 patients with cirrhosis had Child-Pugh A. 16 patients had a
previous diagnosis of hepatocellular carcinoma (HCC) and 2
were on a transplant list due to HCC. 32 % had gastro-esophageal
varices. 58 % had genotype 1, 10 % genotype 2, 23 % genotype
3, and 9 % genotype 4. 115/179 patients had baseline resistance
tests available. Resistance associated mutations (RAS)
were detected in 82 %. 46 % had single RAS. The most common
mutation was Y93H. All patients received 12 weeks of SOF/
VEL/VOX. Ribavirin was added in 22%. All patients completed
12 week of treatment. SVR data were available for 172/179
patients at week 4 and for 169/179 at week 12. By intention to
treat analysis (ITT) 169/174 (94 %) achieved SVR 4 and 162/179
(91 %) achieved SVR 12. In the ITT analysis, genotype 3 was
associated with lower SVR12 (33/42, 77 %). However, according
to per protocol analysis there was no significant difference
between the genotypes with 92 % SVR (33/36) for genotype 3.
De novo HCC occurred in 6 patients (0-3 months after end of
treatment) and 1 patient had a recurrent HCC. The only features
according to per protocol analysis that were associated with
treatment failure in a univariate analysis were cirrhosis and
onset of HCC. Baseline RASs were not associated with worse
outcome. 2/7 patients who had virological failure were treated
with ribavirin.

Ref; Degasperi et al. J hepatology 2019:

Comment: In this real life study different genotypes were
included. The treatment seems equally effective in all the genotypes
even though the ITT, but not the per protocol analysis,
showed somewhat inferior results in genotype 3. Treatment
outcome was not affected by baseline RASs and the addition of
ribavirin to some patients added no benefit.