Efficacy of lead-in silibinin and subsequent triple therapy in difficult-to-treat HIV/hepatitis C coinfected patients

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1 Second Silibinin Workshop, Cologne, 23 rd May 2014 Efficacy of lead-in silibinin and subsequent triple therapy in difficult-to-treat HIV/hepatitis C coinfected patients Dominique L Braun, MD Division of Infectious Diseases and Hospital Epidemiology University Hospital Zurich, University of Zurich

2 Disclosures This work was supported by the Swiss National Science Foundation (grant number 33CS30_134277, SHCS project 688). The investigational medicine product was provided by Rottapharm Madaus. D. Braun received a grant from Rottapharm Madaus / 1

3 Real life: 48yo patient HIV 1991, CDC C2 VL <20c/ml; CD4 415 (25%) TNV, FTC, LPV/r, RGV HCV 1992, Cirrhosis, Child A GT 1a, IL-28B C/T, HCV-RNA IE/ml Fibroscan 35.8kPa, Bx 09: METAVIR F3/ISHAK 5 Esophageal varices bleeding (6x ligation) Normal transaminases, AFP 9ug/l pegifn+rbv: 6/2009 only 3 wk: hospitalisation pegifn+rbv: 2/2010-6/2010: Non-response Co-medication Pravastatin, Carvedilol, ASS, Mirtazapin, Lorazepam /

4 HCV viral load IE/ml Hb 134 g/l WBC 4.90 G/l Plt 90 G/l /

5 AZT DDC 3TC Tenofovir Lopinavir/r Zidovudin/Lamivudin Tenofovir Lopinavir/r Raltegravir Failure CD4 HIV-RNA /

6 To treat or not to treat? / 26. Mai

7 Provisional Guidance on the Use of Hepatitis C Virus Protease Inhibitors for Treatment of Hepatitis C in HIV-Infected Persons, Thomas et al, Clinical Infectious Diseases 2012;54(7): /

8 Limited efficacy of current hepatitis C triple therapy Efficacy of current hepatitis C virus (HCV) triple-therapy is limited in HIV/HCV-coinfected patients with advanced liver fibrosis and nonresponse to previous peginterferon-ribavirin. Low chance to achieve a sustained virological response (SVR) during triple-therapy (only 30% 1 ). On-treatment failure reported in up to 50% 2. 1 De Meyer, Hepatology, Zeuzem, NEJM, / 26. Mai

9 Silibinin for hepatitis C treatment Silibinin targets different steps in the HCV lifecycle 1. Pilot study: administration of 20 mg/kg intravenous silibinin significantly reduced HCV RNA) in 20 HCV-monoinfected patients with previous null-response to peginterferon-ribavirin therapy 2. Intravenous silibinin followed by triple-therapy in HIV/HCVcoinfected patients with advanced liver fibrosis and previous failure of peginterferon-ribavirin therapy 1 Guedj, Journal of Hepatology, Ferenci, Gastroenterology, 2008 / 8

10 Silibinin, the magic bullet? 2 Ferenci, Gastroenterology, 2008 / 26. Mai

11 Patients in urgent need for immediate HCV treatment Describe efficacy and safety of a 14-day lead-in of intravenous silibinin in HIV/HCV-coinfected patients with advanced liver fibrosis who failed on previous treatment with peginterferon-ribavirin. Assess the viral response to silibinin and the following tripletherapy, during and at the end of treatment Patients: documented history of previous failure of peginterferonribavirin, including null response (NR), partial response (par), relapse, or viral breakthrough Advanced liver fibrosis: METAVIR fibrosis score 3 / 26. Mai

12 Inclusion criteria: most difficult to treat patients / 26. Mai

13 Previous failure of peginterferon-ribavirin 10 8 PR HCV RNA [log 10 IU/mL] bld Time [weeks] Braun et al, HIV Medicine, ahead of print / 12

14 Silibinin lead-in for 14 days Lead-in therapy: intravenous silibinin 20 mg/kg/day 14 days After a 14-day intravenous silibinin lead-in treatment, standard triple-therapy day 15 Triple therapy continued for 12 weeks, followed by 36 weeks of peginterferon-ribavirin / 26. Mai

15 Silibinin followed by triple-therapy highly effective Four of six patients 3 log 10 IU/mL, two patients a 2 log 10 IU/mL HCV RNA decline; mean HCV RNA decline 2.6 log 10 IU/mL After silibinin lead-in therapy and initiation of triple-therapy: five of six patients HCV RNA below the limit of detection at week 2, all six patients at week 12 Patient B with genotype 1e: viral breakthrough at week 32. Drug-resistance testing of the HCV NS3 protease region: I132V mutations. Four of five (80%) patients showed a SVR 24. One patient not yet reached week 24 after treatment stop but with SVR 12. Braun et al, HIV Medicine, ahead of print / 14

16 Sustained virological response in four of five patients (80%) Braun et al, HIV Medicine, ahead of print / 26. Mai

17 Excellent tolerability of intravenous silibinin Intravenous silibinin well tolerated without serious adverse events. The most common adverse event sensation of heat in three of six patients. Antiretroviral drug concentrations (i.e., ATV, RGV, EFV) not significantly influenced by silibinin lead-in therapy. All results of trough levels within the standard references values. / 26. Mai

18 Treatment response higher than reported in the literature The REALIZE trial: SVR 12 in 29% of 72 HCV-monoinfected patients with previous NR, retreated with telaprevir 1 On-treatment virological failure in overall 18% of patients (i.e., in 52% with prior NR, 19% with par, and 1% of relapsers) 2. French early-access program ANRS C020-CUPIC: 674 monoinfected cirrhotic patients with HCV genotype 1 and previous NR: SVR 12 only 29% in the telaprevir group 3. ANRS CO13-HEPAVIH cohort/escmid European Study: 65 HIV/HCV coinfected patients (69% previous NR, 80% GT 1A, mean transient elastometry 19.3 kpa): virological response at week 48 only 17% in the telaprevir group 4. 1 Zeuzem, NEJM, De Meyer, Hepatology, Fontaine, EASL, Miailhes, ECMID, 2013 / 26. Mai

19 High SVR rate related to lead-in therapy? The 2 3 log 10 IU/mL viral RNA decline during silibinin lead-in and lower viral load when starting triple-therapy might have been key for subsequent treatment success. Patients with prior failure: cornerstone of triple-therapy protease inhibitor Peginterferon-ribavirin weak partners with increased risk for the emergence of HCV resistance variants and viral breakthrough. Lower baseline viral load: more rapid viral clearance, prevention of development of resistance. Tolerability of silibinin excellent with no treatment discontinuations / 18

20 New era of next-generation anti-hcv drugs, but Extremely high costs of DAAs may limit access to therapy outside of high-income countries. Certain patients (e.g., with cirrhosis) cannot wait for price reductions within the next years and have to be treated NOW.. In HIV/HCV coinfected patients on salvage ART significant drugdrug interactions limit the use of certain direct acting agents (DAAs) 1. 1 Dieterich et al, CROI 2014, abstract 24 / 26. Mai

21 Limitations Small patient number. Contribution of the silibinin lead-in on the SVR rate difficult to estimate. / 26. Mai

22 Conclusions Lead-in with silibinin before triple-therapy is highly effective in difficult-to-treat HIV/HCV-coinfected patients. This approach might be considered for selected patients in need for immediate treatment for whom new HCV-drugs are not yet available or affordable. / 21

23 Back to the patient D -14 BL Silibinin D 7 Silibinin BL Telaprevir Wk 1 Wk 2 Wk 4 Wk <10 <10 <10 <10 ART: TNV, ATV/r, RGV Telaprevir pegifn: 180ug/Wk s.c. RBV: 1000mg (65kg) Mirtazapin and Carvedilol devided in half /

24 We thank the patients and all persons involved in their care. We acknowledge the team at Janssen diagnostics. We would like to thank Rottapharm Madaus and Max Zeller Söhne AG for providing Legalon SIL and the continuous support / 26. Mai

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