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Liver fibrosis regression after anti HCV therapy and the rate of death, liver-related death, liver-related complications, and hospital admissions in HIV / HCV coinfected patients with cirrhosis

J.L. Casado, S. Bañon, C. Quereda, A. Moreno, M.J. Perez-Elías, S. Moreno

Infectious Diseases, Ramon y Cajal Hospital, Madrid, Spain

Session TUAB 02HCV: The Good News ContinuesAbstract TUAB 0204

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Introduction• Cumulative evidence demonstrates that SVR is associated

with a lower rate of death and liver related complications1,2. However, in spite of a lower risk, patients with cirrhosis are not entirely protected against the development of liver complications or HCC after SVR3,4.

• We and others have found an important rate of fibrosis regression (FR) during the follow-up of HIV/HCV-co-infected patients with SVR5.

• In hypothesis, FR after SVR in patients with cirrhosis should be associated with even a lower risk of hepatic complications, and a prolonged survival.

1Mira JA, et al. Clin Infect Dis 2013;56:1646-1653. 2Berenguer J, et al. Hepatology. 2009;50:407-413 3Merchante et al. Clin Infect Dis 2013;56:143-150; 4Aleman S et al. Clin Infect Dis 2013;57:230-236.5Casado JL, et al. J Viral Hepat 2013;20:829-837.

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Objective

• To determine the impact of FR and/or SVR on the clinical outcome of HIV/HCV co-infected patients with cirrhosis, in terms of:

– Overall death, – Liver-related death, and – Liver-related complications

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Methods (I)• Observational cohort study at the Hospital

Ramón y Cajal, in Madrid.

• Inclusion criteria:– All HIV/HCV coinfected patients who received therapy

with pegylated interferon and ribavirin since 2004– Baseline liver biopsy or transient elastography (TE)– Followed up by TE beginning in 2006.

• Fibrosis regression was defined as a confirmed reduction of at least one point in Fibrosis Metavir Score during the follow-up, without worsening in a successive TE, if available.

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Methods (II)• Primary end-points were death from any cause

and liver-related death. – The time to the event was the length of time since the end

of antiviral therapy until the primary endpoint.

• Secondary end-points were the development of a liver-related complication (ascites, encephalopathy, GI bleeding, HCC) and the number of hospital admissions. – Liver transplantation was considered as a liver-related

endpoint.

• For patients who did not die or were not transplanted, the analysis was censored at July 2014.

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Methods (III)

• Cumulative incidence curves of liver mortality and liver-related complications according to response and fibrosis regression were plotted using the Kaplan-Meier method. The differences between groups were assessed using log-rank tests.

• A multivariate Cox model was used to assess the independent effect of variables on the development of events during the follow-up.

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Baseline characteristics

1 92 patients with baseline liver biopsy2 41 patients with baseline TE

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Fibrosis Regression according to SVR

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SVR, Fibrosis Regression and Outcomes

TE, transient elastography; L-R, liver related; IR, incidence rate

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Overall Death and Liver-related Death according to SVR/FR

Liver- related death

Overall death

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Overall Death and Liver-related Death according to SVR and FR

Overall death Liver- related death

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Cox Regression AnalysisFactors associated with Outcome

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Conclusions

• Our study clarifies the risk of complications after therapy in HIV-infected patients with cirrhosis, showing a lower rate if fibrosis regression is attained in addition to SVR.

• Moreover, we demonstrate that the histological benefit is clearly associated with the lowest risk of any-cause death, liver-related death, and hospital admissions.

• Of clinical application, LSM is useful in demarcating cirrhotic patients at a high risk for complications after therapy, and who would require a more frequent check-up. Sequential LSM after therapy could be useful in the management of the patients, irrespective of achieving SVR.