Material and Methods
This is a single-center prospective cohort study designed and performed
in Hepatitis C clinic of Shariati hospital affiliated to Tehran
University of Medical Sciences during 2016-2017. All HCV-infected
subjects with cirrhosis (defined as initial LS greater than 12.5 KPa)
were enrolled. Patients presenting with any of the following conditions
were excluded: HIV co-infection, advanced renal failure (defined as eGFR
< 30ml/min/1.73m2), organ transplant, HCC,
and previous failure of NS5A inhibitor-containing regimen. The HCV
diagnosis was confirmed by a sensitive polymerase chain reaction (PCR).
A single once daily fixed-dose combination tablet containing 400 mg of
sofosbuvir and 60 mg of daclatasvir (Sovodak, Fannavaran Rojan Mohaghegh
Daru, Tehran, Iran) was administered either for 12 weeks with
weight-based ribavirin (1000 or 1200 mg) or 24 weeks alone. TE was
performed before and six months after end of treatment (EOT). Patients
who could not undergo TE, did not achieve SVR, and lost to follow-up
were excluded as well. The study protocol was in accordance with the
ethical guidelines of the 1975 Declaration of Helsinki and was approved
by the Institutional Review Board of the Digestive Disease Research
Institute of Tehran University of Medical Science
[IR.TUMS.DDRI.REC.1396.8] and written consent was obtained from all
patients.
TE was performed using the FibroScan 502 machine (Echosens, Paris,
France), by the same physician in all cases. Based on the manufacturer’s
guidelines, The M probe was used when the thoracic parameter was
< 75 cm, and the XL probe when the thoracic parameter was
> 75 cm. During procedure, the patient lied in a dorsal
decubitus position and maximally abducted the right arm. The probe was
positioned on the skin overlying the right lobe of the liver, through
the intercostal spaces. The median value of at least 10 valid
measurements was recorded for each subject and considered valid if the
interquartile range was less than 30% of the estimated median. The
results were expressed in Kilopascals. The same method was used for CAP
measurement.