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Berge et al. Clinical outcomes of direct-acting antivirals

encephalopathy or variceal bleeding) of 3.9-5.7% [4,6] by biopsy, transient elastography (> 14.5 Kpa) or
has been reported. unequivocal clinical diagnosis (chronic HCV with
previous episodes of decompensation or with imaging
Before 2011, the best potentially curative treatment tests showing portal hypertension signs).
option for chronic HCV infection was pegylated
interferon in combination with ribavirin. However, Sustained virological response 12 weeks post-
sustained virological response rates were reported treatment [sustained virological response 12 (SVR12)]
to be as low as 33% in cirrhotic patients , with an was defined as undetectable HCV RNA at week 12
[7]
significant number of side effects . However, it has after the end of therapy. For HCV RNA detection we
[8]
been demonstrated that the achievement of a sustained used real time polymerase chain reaction, with a limit
virological response after interferon-based therapy is of detection of 15 IU/mL.
associated with lower rates of hepatocellular carcinoma
and with lower rates of hepatic decompensation [9,10] . A Follow-up started the first day of treatment, which was
regression of fibrosis after viral eradication has also defined as time 0. We analyzed: (1) the development of
been reported [11] . hepatocellular carcinoma. We performed an ultrasound
every 6 months and, when it showed a suspicious
The arrival of second-generation direct-acting antivirals focal lesion, the diagnosis of hepatocellular carcinoma
improved the sustained virological response rates to was completed with a triple-phase computerized
more than 90%, even in compensated cirrhotic patients, tomography scan and/or with a contrast enhanced
with fewer side effects [12,13] . However, the achievement magnetic resonance imaging; (2) the development of
of sustained virological response with this treatment hepatic decompensation, which included jaundice,
does not appear to be associated with a decrease in variceal bleeding, ascites and/or encephalopathy;
the occurrence of hepatocellular carcinoma in the short (3) the evolution of liver function, using Child-Pugh
term [14] . It may even be associated with a higher rate of and MELD scores, which were calculated on the first
tumor recurrence than what it is expected [15] . A recent day of treatment and on the last clinic visit, at least
prospective multicenter study did not find any evidence one year later. We also performed a brief statistical
of an increased risk of hepatocellular carcinoma analysis, using paired t test to compare means of
recurrence in patients treated with direct-acting baseline and follow-up platelet counts and bilirubin and
antivirals [16] . One report additionally demonstrated an albumin levels. A P value below 0.05 was considered
improvement in liver function tests among patients with statistically significant. The analysis was performed
decompensated liver disease after treatment with oral using IBM statistical product and service solutions
antiviral therapy [11] .
statistics for Macintosh, version 21.0 (Armonk, NY,
IBM Corp).
The aim of our study was to assess the clinical impact of
direct-acting antiviral treatment in terms of the evolution RESULTS
of liver function and in terms of the development
of clinical decompensations and hepatocellular Baseline characteristics of patients
carcinoma in patients with compensated HCV-related
cirrhosis after one year of follow-up. We analyzed data from 90 consecutive patients with
compensated HCV-related cirrhosis who were treated
METHODS with direct-acting antivirals between January and
October 2015 and completed a follow up of at least
Data from all the patients with compensated HCV- one year after initiation of therapy.
related cirrhosis, without co-existent HIV or hepatitis
B infection, who were treated at our center with direct- The median follow-up time after initiation of direct-acting
acting antivirals between January and October 2015, antiviral treatment was 16 months (12-21 months).
were retrospectively collected. At the end of October Seventy-three percent of participants were males, the
2016, the database included 129 patients. We excluded mean age was 58.1 years and the most frequent genotype
39 patients because they did not complete a follow- was 1b (52.2%). Only 37.8% of patients were naïve, and
up of 12 months, which included at least physical 11% had liver graft cirrhosis. All patients were Child-Pugh
examination, hepatic ultrasound, and blood tests every A class at the start of the treatment and the median MELD
6 months. Fourteen patients were lost to follow-up score was 7 (6-16). At the initiation of therapy, mean
during the first year and 25 patients had the last clinic bilirubin level was 1.06 ± 0.27 mg/dL, mean platelet count
or ultrasound appointment after October 2016. was 117,788 ± 50,546/mm , and mean albumin level was
3
4,140 ± 424 mg/dL. The baseline characteristics of the
The diagnosis of cirrhosis was previously established study population are shown in Table 1.
210 Hepatoma Research ¦ Volume 3 ¦ September 27, 2017