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Umar et al. Hepatoma Res 2018;4:71 I http://dx.doi.org/10.20517/2394-5079.2018.31 Page 3 of 7

Since the patients were included through non-probability consecutive sampling technique and in addition
it was a single group study, lacking any control group based on ethical grounds, hence it was a quasi-
experiment study. Keeping the expected proportion of patients with attainment of SVR in Genotype 3
patients as 99% according to recent ALLY 3+ study, the absolute precision as 5% and the level of confidence
as 95%, the minimally required sample size was estimated to be 16. This sample size was calculated on
OpenEpi, Version 3 sample size calculator. One patient discontinued the treatment due to non-hepatic
cause whereas one patient did not comply with the treatment fully due to intolerance.

[2]
Treatment advised as per national consensus practice guidelines of Pakistan . Treatment Naïve or In-
terferon experienced non-cirrhotic patients were offered generic sofosbuvir 400 mg and daclatasvir 60
mg once daily for 12 weeks. Ribavirin 1000 mg (in patients < 75 kg) or 1,200 mg (in patients > 75 kg) was
added to the regimen and the treatment extended for 24 weeks for cirrhotic patients and/or sofosbuvir
experienced patients. Patients with decompensated cirrhosis if ribavirin eligible were offered a 12 week
course and if ribavirin ineligible a 24 week course respectively.

Patients were followed on regular intervals with PCR at 4 weeks after the start of treatment, at the end of
treatment and 12 weeks after completion of treatment. All PCRs performed on Real Time PCR by TagMan
Probe and sequence specific primers using Scacae Biotechnology Sa Cycler-96 instrument with a minimal
threshold of 50 IU/mL used for reporting negatives. Hepatitis C virus (HCV) PCR below the threshold of
quantification at 4th week of treatment is defined as a rapid virologic response (RVR), at the end of treatment
as end of treatment response (ETR) and 12 weeks post treatment as SVR12. Adverse events were documented
on each follow-up and patients were asked regarding fatigue, headache, nausea, insomnia, itching, anemia,
weakness, rash, loss of appetite, oral ulcers, diarrhea or any other side effects. Follow-up PCRs were
performed at 4th week of treatment, end of treatment and 12 weeks post treatment. All those patients were
included in the study that had at least one follow-up PCR during or after the course of treatment.

Before the actual data collection were written and verbal informed consent was sought from all
the respondents after explaining to them the nature and purpose of study, data were collected by a
standardized performa. All the data were entered and analyzed in SPSS v.22. Descriptive analytic
component included frequencies and percentages of various categorical variables.

RESULTS
A total of 102 patients were included in the study having HCV genotype 3 amongst which 63% were males
and 37% were females. The mean age of participants was 48.11 years (± 12.70 years). The mean PCR HCV
6
RNA quantitative levels were 3.5 × 10 IU/mL. The 52 (51%) patients had cirrhosis amongst which 37 (36.3%)
were having decompensated liver disease. Study participants who were naïve to any previous Interferon
treatment were 84 (82.4%) while amongst remaining 18 (17.6%) patients who had HCV treatment
experienced previously, 3 (17%) were non-responders while 15 (83%) were relapsers.

Among participants 36 had a follow up PCR at 4th week of treatment with a RVR of 86.11% (31/36). Out
of 102 patients 78 patients had follow up PCR at the completion of therapy with an ETR of about 96.1%.
ETR in treatment naïve was 96.92% (63/65), treatment experienced was 92.30% (12/13), cirrhotics was 95.1%
(39/41) whereas in decompensated cirrhosis patients was 93.10%(27/29) respectively. Thirty patients had a
follow up of 12 weeks post treatment with a SVR12 of 83.33% (25/30) amongst which treatment Naïve had
a response rate of 84% (21/25), treatment experience 80% (4/5), cirrhotics 81.25% (13/16) and patients with
decompensated cirrhosis had a SVR12 of 83.33% (10/12) respectively. The distribution of virological responses
in study participants is displayed in Figure 1. For categorical variables we applied chi-square test to explore
association between the treatment status (Naïve, interferon experienced or sofosbuvir experienced) and
virological response (RVR, ETR or SVR) but no statistically significant difference was observed in patients