Virological and clinical significance of detectable HCV-RNA below limit of quantification at End-of-Treatment in patients treated with direct antiviral agents
Author(s): ,
Ubaldo Visco Comandini
Affiliations:
Infectious Diseases and Hepatology,National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS,Rome,Italy
,
Daniele Lapa
Affiliations:
Virology,National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS,Rome,Italy
,
Raffaella Lionetti
Affiliations:
Infectious Diseases and Hepatology,National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS,Rome,Italy
,
Chiara Taibi
Affiliations:
Infectious Diseases and Hepatology,National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS,Rome,Italy
,
Laura Loiacono
Affiliations:
Infectious Diseases and Hepatology,National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS,Rome,Italy
,
Marzia Montalbano
Affiliations:
Infectious Diseases and Hepatology,National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS,Rome,Italy
,
Maria Capobianchi
Affiliations:
Virology,National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS,Rome,Italy
,
Gianpiero D'Offizi
Affiliations:
Infectious Diseases and Hepatology,National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS,Rome,Italy
Anna Rosa Garbuglia
Affiliations:
Virology,National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS,Rome,Italy
EASL LiverTree™. Visco Comandini U. 04/22/17; 168237; SAT-287 Topic: Monitoring
Dr. Ubaldo Visco Comandini
Dr. Ubaldo Visco Comandini
Contributions Biography
Abstract

SAT-287

Topic: Viral hepatitis: Hepatitis C - Clinical (therapy)

Background and aims
Detectable HCV-RNA below limit of quantification at end-of-treatment (EOT) is frequently observed with Abbot Real Time HCV-RNA Test (ART) and may induce concern for subsequent viral failure.

We aimed to evaluate its clinical and virological significance in a real world large clinical setting using DAAs.

Methods
We enrolled 337 consecutive patients treated with DAAs (SOF/SMV 25%, SOF/LDV 22%, SOF/DCV 22%, SOF/RBV±pIFN 22%, 2D/3D 9%) following EASL treatment guidelines in an observational, retrospective, mono-centre study.

Blood samples were analysed with ART with a lower limit of quantification (LLQ) of 12 UI/ml, before treatment, every 4 weeks (W) during treatment, at EOT, 4W (PTW4) and 12W (PTW12) after discontinuation.

All the samples with a result of “detected, not quantifiable” (DNQ) at EOT, were re-analysed by an ultrasensitive HCV-RNA test (US) with a LLQ of 4 UI/ml (Garbuglia, PLoS One, 2016).

EOT samples of patients with viral relapse and samples with “sporadic” DNQ (preceded and followed by an undetectable HCV-RNA) result were also analysed by US test.

Results
Patient were on Metavir F4 (68.6%) or F3 fibrosis (22.8%) or liver transplanted (16.6%). HCV genotypes were 1a(29.7%), 1b(33%), 2(9.2%), 3(16.3%) or 4(11.6%).

Overall, 16 patients experienced post treatment HCV relapse (4.7%).

The frequency of DNQ samples progressively decreased during and after treatment (p<0.0001, Fig.1) and was not associated to any specific DAA regimen, HIV infection, liver transplant or Child-Pugh class.

A significant association was observed between DNQ and F3 stage only at PTW4 (p<0.001).

Results obtained by US test are shown in Table 1. Only a single patient out of 18 with detectable HCV-RNA with both tests at EOT or PTW4 experienced relapse. Out of 16 relapsers only 2 showed DNQ at EOT (12.5%).

 

Table 1. Correspondence between results obtained with ART and US test

 

ART

n.

US protocol undetectable

US protocol DNQ

US protocol quantifiable

Correspondence

DNQ samples (all)

55

31

12

12

43.6%

EOT DNQ (in SVR)

28

16

4

8

42.9%

PT W4 DNQ (in SVR)

11

4

6

1

63.6%

EOT DNQ (in relapsers)

2

1

0

1

50%

Sporadic DNQ (in SVR)

14

10

2

2

28.6%

Undetectable at EOT in relapsers

14

13

0

1

92.3%

 

Conclusions
Presence of DNQ results at EOT does not predict HCV relapse, independently to the sensitivity of the test used.

In less than half of DNQ samples, HCV-RNA detection is confirmed by the US test with LLQ of 4UI/ml.

Frequency of DNQ samples decreases during and after treatment, suggesting to reflect treatment efficacy and not aspecific RNA carry over in PCR

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