Gareth Tudor-Williams
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1 DEBATE! HCV + HIV co-infected children in Russia should be treated now Gareth Tudor-Williams Children and HIV: Problems and Prospects St. Petersburg Russia 26 th Sept 2014
2 Dr. José Tomás Ramos Amador One of the great Spanish intellectuals Source: Google Images, 2014
3 Доктор Мишкин
4 I must need my head examining to try and win a debate when he is opposing me!
5 HCV co-infected children in Russia should be treated NOW
6 HCV is not good for children
7 Long-term results of NOT curing HCV
8 Best Practices in the Management of HCV/HIV Coinfection clinicaloptions.com/hepatitis Evidence from adult HCV/HIV coinfection: HIV accelerates the natural course of HCV infection [1] HAART can slow fibrosis progression but not down to the rate in HCV mono-infection [2] Liver disease associated with HCV infection is now a leading cause of morbidity and mortality among HCV/HIV-coinfected patients [3] 1. Rockstroh JK, et al. Am J Gastroenterol. 1996;91: Graham CS, et al. Clin Infect Dis. 2001;33: Weber R, et al. Arch Intern Med. 2006;166:
9 Best Practices in the Management of HCV/HIV Coinfection clinicaloptions.com/hepatitis HCV Co-infection vs Mono-infection: Cumulative Incidence of Decompensation 10-year hepatic decompensation risk 83% higher in coinfected patients - Adjusted HR 1.83 (95% CI: ) 0.2 HIV/HCV coinfected HCV monoinfected Yrs to Hepatic Decompensation P <.001 Lo Re V, et al. IAC Abstract WEAB0102.
10 Chronic HCV infection in children Prevalence of fibrosis Goodman ZD, Hepatology 2008
11 It s not just about the liver
12 Ask anyone who has successfully cleared HCV They feel better!
13 HCV Replication Cycle (1) HCV Plasma Membrane Receptors (2) (3) 5 +verna 3 (4) Endoplasmic Reticulum Cell Nucleus E2 NS4A E1 p7 NS2 NS5A NS4B NS3 CORE 5 +verna (7) 3 NS5B (5) (8) Membranous Web (9) Lipid Droplets (6) 3 5 -verna
14 No reverse transcription No integration No intranuclear component This virus can be eradicated from the body and infected individuals can be cured!
15 SVR (%) HCV mono-infection in Children: results of treatment Genotype 1 Genotype 2/ Christensson Wirth González-Peralta Wirth Schwarz (n=11) (n=41) (n=118) (n=107) (n=55) IFN+RBV PEG-IFN+RBV Christensson et al. Clin Infect Dis Wirth et al. Hepatology 2002, González-Peralta et al. Hepatology 2005; Wirth et al. Hepatology 2005; Schwarz et al. Gastro 2011.
16 What about HCV / HIV co-infection? Some of the best evidence in the world come from colleagues here in Russia
17 HCV treatment in children and young women with HIV/HCV co-infection in St Petersburg, Russia Dr Milana Miloenkо Republican Hospital of Infection Diseases 7 th CHIVA annual meeting, Leeds 2013
18 50-78% of people living with HIV are co-infected with HCV in Russia Ladnaya et al, 2010 Kravchenko et al, 2010
19 HCV genotype distribution, Russia Vedernikov, Moskow, 2010
20 Aim of the study To assess the efficacy and tolerability of HCV treatment with PEG-IFN and ribavirin (RBV) in HIV/HCV co-infected children and youth
21 Methods 264 children and young women with HIV infection aged <25 years Of those 50 were co-infected with HCV (19%) 30/50 patients (60%) received treatment with PEG-IFN/RBV Case note review and descriptive analyses were carried out
22 Treatment results 18 had completed treatment 17 were at 6 months post treatment: 13/17 (76%) had SVR But 2 with GT1a relapsed after 1 year One patient had end of treatment response and remains undetectable few weeks post treatment Of 12 patients still on treatment, 11 had EVR12
23 Treatment results 18 had completed treatment 17 were at 6 months post treatment: 13/17 (76%) had SVR But 2 with GT1a relapsed after 1 year 100% 80% 60% 40% 86% 70% 50% 20% 0% Genotype 1 Genotype 3 One patient had end of treatment response and remains undetectable few weeks post treatment Of 12 patients still on treatment, 11 had EVR12
24 Safety and toxicity There were no treatment discontinuations due to toxicity or intolerance 9/30 (30%) required dose modification: 5/30 (16.7%) RBV dose was reduced due to anaemia 2/30 (6.6%) PEG-INF dose was reduced due to thrombocytopenia 2/30 (6.6%) moderate neutropenia not requiring PEG-IFN dose correction GCSF was given in these 2 cases
25 Conclusions In this cohort of HIV/HCV co-infected young patients treated with P-IFN/RBV, 86% with GT3 achieved SVR Tolerability of PEG-IFN/RBV was better than reported in adult studies Our results demonstrate the efficacy of treatment for HIV/HCV GT3 co-infected patients For those with GT1, new treatment options are needed.
26
27 Directly Acting Antivirals - DAA Others MSD Nitazoxanide (Romark) Toll-like receptor IMO 2125 (Idera) Toll-like receptor ANA773 (Anadys) DAA Combinations INF lambda (Zymogen/ NovoNordisk) Debio025 and NIM811 cyclophilins (Novartis) Pharmasett Vertex Caspase inhib (Gilead) Gilead Roche Taribavirin (Valeant) BMS ALBUFERON (HGS/Novartis) Preclinical Phase I Phase II Phase III Filed PSI879(Pharmasset) PSI7851 (Pharmasset) BI R7128 (Roche/Pharmasset) Japan Tobacco filibuvir (PFE) MK 0608 (MSD) PSI-7977 (Pharmasset) Nuc- Polymerase inhibitors R0622 (Roche) Medivir/Tibotec GL59393 (GSK) PSI938(Pharmasset) Biocryst INX189 (Inhibitex) BMS (nuc or non-nuc)(bms) Idenix GSK NS5A inhibitors inhibitors AZD7259 NS5A (AZN) PPI461 (Presidio) Enanta Vertex BMS NS5A (BMS) BMS NS5A (BMS) GS9256 (Gilead) TMC-435 (J&J/Tibotec) IDX316 & 316 (Idenix) MK5172 (MSD) Boceprevir (MSD) MK7009 (MSD) ITMN-191/R7227 (Roche/Intermune) ABT450 (ABT) PHX1766 (Phenomix) Telaprevir (J&J/Vertex) BMS (BMS) BI (BI) ACH1625 (Achillion) GS9190 (Gilead) ANA598 (Anadys) BI (BI) VX222 (Vertex) ABT333. ABT072 (ABT) VCH759 (Vertex) MK 3281 (MSD) IDX375 (Idenix/NVS) Non-Nuc Polymerase inhibitors Updated October 2010 Protease inhibitors
28 Potential IFN-free DAA combinations for treatment of HCV Protease Inhibitor + Nucleoside Danoprevir + Mericitabine NS5b Nucleoside + NS5a inhibitor Sofusbuvir + Ledipasvir (+/- RBV) Protease Inhibitor + NS5a + polymerase ABT450/r + ABT267 + ABT333 Protease Inhibitor + NS5b Non-nuc Telapravir+VX222 Faldaprevir+BS207127
29 SVR12 (%) ION-1: SOF/LDV ± RBV in GT1 treatment-naïve adults SVR12 rates in the mitt population (N=852): subgroup results do not include patients who withdrew consent or who were lost to follow-up Overall GT1a GT1b n N Eleven patients achieved SVR12, but were not sub-genotyped; Error bars: 95% CI. Afdhal N, et al. New Engl J Med 2014; online DOI: /NEJMoa
30 SVR12 (%) Best Practices in the Management of HCV/HIV Coinfection clinicaloptions.com/hepatitis PHOTON-1: Sofosbuvir + RBV in GT1/2/3 HIV/HCV Coinfection Phase III open-label study HCV treatment-naive or - experienced HIV+ patients (N = 223) 76% on ART (VL < 50 cells/ml), various standard regimens Safety profile similar to mono-infected patients; Most frequent AEs: fatigue, insomnia, headache, nausea, diarrhea (? RBV effect) Sulkowski MS, et al. AASLD Abstract n/n 0 Virologic Outcomes for Treatment-Naive Patients by GT 76 87/ / / 42 GT1 GT2 GT3
31 SVR4 (%) Best Practices in the Management of HCV/HIV Coinfection clinicaloptions.com/hepatitis STARTVerso4: Faldaprevir + PegIFN/RBV in GT1 HCV/HIV Coinfection Phase III open-label study or 48-week regimens: faldaprevir + pegifn/rbv for 12 or 24 weeks, then pegifn/rbv alone HCV treatment-naive or previous relapser HIV+ patients (N = 308) 60 96% on ART (VL < 50 cells/ml) Safety profile similar to monoinfected pts 40 Most frequent AEs: nausea, fatigue, diarrhea, headache Decrease in hemoglobin consistent with pegifn/rbv historical data 20 n/n = 0 89/ 123 Faldaprevir 120 mg* Faldaprevir 240 mg 72/ 86 Faldaprevir 240 mg* Rockstroh JK, et al. AASLD Abstract *24 wks of therapy; 12 wks of therapy
32 My learned friend will say There are no licensed direct acting antivirals for children with GT1 HCV infection
33 He is right but this is not an excuse to say they should not be treated! We must treat children with GT1 infection in well designed, multicentre clinical trials!
34 Conclusion Good results with P-IFN/RBV in favour of treating all children with HCV genotypes 2 / 3 co-infection Children with GT1 co-infection need treating now in the context of welldesigned clinical trials
35 VOTE YES! Please treat me now! I will feel better!
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