Dr Janice Main Imperial College Healthcare NHS Trust, London
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1 BHIVA AUTUMN CONFERENCE 2014 Including CHIA Parallel Sessions Dr Janice Main Imperial College Healthcare NHS Trust, London 9-10 October 2014, Queen Elizabeth II Conference Centre, London
2 BHIVA AUTUMN CONFERENCE 2014 Including CHIVA Parallel Sessions Dr Janice Main Imperial College Healthcare NHS Trust, London COMPETING INTEREST OF FINANCIAL VALUE > 1,000: Speaker Name Statement Dr Janice Main None Date October October 2014, Queen Elizabeth II Conference Centre, London
3 HEPATITIS C TREATMENT: FROM BENCH TO BEDSIDE
4 TREATMENT Interferon, peginterferon, ribavirin +/- telaprevir/boceprevir Side effects Interactions Disappointing results in HIV coinfection
5 TREATMENT NOW Oral only therapies Directly acting antivirals (DAA) Recognition of host and viral factors Early access programme Global/WHO issues
6 EASL 2011 AASLD 2011
7
8
9 SOFOSBUVIR genotype 2 and 3 TREATMENT sofosbuvir 12 weeks n =10 Sofosbuvir ribavirin 8 weeks Plus PEG 8 weeks n =10 SVR n (%) 6 (60%) 9/9 (100%)
10 SOFOSBUVIR genotype 1 TREATMENT prev NR treatment naïve sofosbuvir ribavirin 12 weeks n = 10 Sofosbuvir ribavirin 12 weeks n = 25 SVR n (%) 1 (10%) 21 (84%)
11 PHARMA ISSUES COSTS Pharmasett (82 employees, net loss $91.2 million) taken over by Gilead ($11 billion) Sofosbuvir $1000/day SOVALDI SO EXPENSIVE Products from different companies
12 NEW TRIAL DESIGNS SVR12 Interferon free Shorter treatment courses Response guided therapy (RGT)
13 HEPATITIS C 5 UT 3 UT C E1 E2 NS2 NS3 NS4 NS5A NS5B NS3/4 serine protease, RNA helicase NS5A RNA dependent RNA polymerase NS5B RNA dependent RNA polymerase 5 UTR antisense oligos 3 UTR ribozymes
14 HEPATITIS C PI s 5 UT 3 UT C E1 E2 NS2 NS3 NS4 NS5A NS5B NS3/4 serine protease telaprevir boceprevir simeprevir asunaprevir ABT-450/r MK5172 vaniprevir faldaprevir deleoprevir
15 HEPATITIS C PI s 5 UT 3 UT C E1 E2 NS2 NS3 Genotype NS4 1 NS5A NS5B Low barrier genotype to resistance Interactions ++ NS3/4 serine protease
16 HEPATITIS C NS5A inhibitors 5 UT 3 UT C E1 E2 NS2 NS3 NS4 NS5A NS5B NS5A RNA dependent RNA polymerase ledipasvir daclatasvir ombitasvir (ABT- 267) MK8742
17 HEPATITIS C NS5A inhibitors 5 UT 3 UT C E1 E2 NS2 NS3 Pangenotypic NS4 NS5A NS5B Low barrier genotype to resistance NS5A RNA dependent RNA polymerase
18 HEPATITIS C NS5B inhibitors NA s 5 UT 3 UT C E1 E2 NS2 NS3 NS4 NS5A NS5B NS5B RNA dependent RNA polymerase sofosbuvir
19 HEPATITIS C NS5B inhibitors NA s 5 UT 3 UT C E1 E2 NS2 NS3 Pangenotypic NS4 NS5A NS5B High barrier genotype to resistance NS5B RNA dependent RNA polymerase
20 HEPATITIS C-NS5B inhibitors NNA s 5 UT 3 UT C E1 E2 NS2 NS3 NS4 NS5A NS5B NS5B RNA dependent RNA polymerase dasabuvir (ABT-333) BMS ABT-072 deleobuvir
21 HEPATITIS C-NS5B inhibitors NNA s 5 UT 3 UT C E1 E2 NS2 NS3 NS4 NS5A NS5B Genotype 1 Low barrier genotype to resistance NS5B RNA dependent RNA polymerase
22 Original Article ABT-450/r Ombitasvir and Dasabuvir with or without Ribavirin for HCV Ferenci P et al, NEnglJMed, 2014 N Engl J Med Volume 370(21): May 22, 2014
23 Study Designs. Ferenci P et al. N Engl J Med 2014;370:
24 Sustained Virologic Response at 12 Weeks after the End of Treatment. Ferenci P et al. N Engl J Med 2014;370:
25 HIV/HCV COINFECTION Interferon based Immunomodulatory > antiviral PI s/ifn/rbv DAA s +/- RBV +/- IFN Drug interactions..
26 ERADICATE: SOF/LDV in ARV-Treated and Untreated HCV/HIV-Coinfected Single-arm phase II trial Patients ARV use in 37 ARV-treated patients: efavirenz (41%), raltegravir (27%), rilpivirine (21%), rilpivirine and raltegravir (8%), efavirenz and raltegravir (3%) Median baseline CD4+ count: ARV treated 576 cells/mm 3 (range: ), ARV untreated 687 cells/mm 3 (range: ) SVR12 in ARV-treated patients: 100%; not yet available in ARV-untreated patients No clinically significant changes in HIV-1 RNA or CD4+ cell count SOF/LDV well tolerated, no discontinuations or grade 4 AEs Wk 12 Patients with HCV GT1 and HIV coinfection (N = 50) SOF/LDV FDC Sofosbuvir/ledipasvir 400/90 mg FDC tablet once daily. Osinusi A, et al. EASL Abstract O14. Reproduced with permission.
27 C-WORTHY (genotype 1) MK-5172 (PI) MK-8742 (NS5A) +/- RBV 12 weeks HIV pos n= 59 Sulkowski et al, EASL 2014
28 C-WORTHY (genotype 1) SVR4 90% no RBV 97% with RBV
29 Simeprevir (TMC435) with Peginterferon/Ribavirin in Patients Coinfected with HCV Genotype-1 and HIV-1: A Phase III Study Dieterich D et al, Clin Infect Dis 2014 n = 106, RGT Triple therapy 12 weeks Treatment naïve ( non-cirrhotic), prior relapsers RGT PR 24 or 48 weeks Prior nullresponders, prior partial responders, cirrhosis PR 48 weeks SVR % in treatment naïve 57.1% in prior null responders 86.7% in prior relapsers 70.0% in prior partial responders
30 QUEST: No Benefit of Simeprevir if Q80K Positive SMV + P/R P/R SVR12 (%) n/n = 0 228/ 267 GT1b 70/ / / 83 GT1a no Q80K 49/ 84 GT1a + Q80K 23/ 44 Q80K present in 34% of GT1a patients. No benefit of simeprevir if Q80K positive Jacobson I, et al. AASLD Abstract 1122.
31 Sofosbuvir and Ribavirin for Hepatitis C in Patients With HIV (PHOTON-1) Sulkowski et al, JAMA 2014 Open-label, non-randomised, uncontrolled phase 3 Treatment naïve Genotype 2 or 3 (n = 68) SOF/RBV 12 weeks Genotype 1 (n = 114) SOF/RBV 24 weeks Treatment experienced Genotype 2 or 3 (n=41) SOF/RBV 24 weeks
32 Sofosbuvir and Ribavirin for Hepatitis C in Patients With HIV (PHOTON-1) Sulkowski et al, JAMA 2014 Open-label, non-randomised, uncontrolled phase 3 Treatment naïve SVR12 Genotype 1 76% Genotype 2 88% Genotype 3 67% Treatment experienced Genotype 2 92% Genotype 3 94%
33 IFλN3 (IL28) and IFλN4 and sofosbuvir Impact on 2 nd phase of viral decay N=60 with 24/52 SOF/RBV, no significant effect on SVR Meissner JID (2014)
34 EARLY ACCESS PROGRAMME Background Some odd results
35 LIVER TRANSPLANTATION AND HCV graft reinfection interferon immunosuppression Fe ribavirin combination PRE PERI POST
36 AASLD guidelines GENOTYPE 1 TREATMENT NAÏVE Eligible to receive IFN PEG/RBV/SOF 12 weeks Not eligible to receive IFN SOF/SIM +/- RBV 12 weeks
37 AASLD guidelines GENOTYPE 2 TREATMENT NAÏVE RBV/SOF 12 weeks GENOTYPE 3 TREATMENT NAÏVE RBV/SOF 24 weeks
38 AASLD guidelines GENOTYPE 4, 5, 6 TREATMENT NAÏVE PEG/RBV/SOF 12 weeks
39 BEDSIDE
40 SUMMARY Exciting new drugs/combinations Shorter treatment courses More effective ( HIV pos = HIV neg) Less toxic Rapidly changing guidelines Host and viral factors Early access programme Expensive Can we eradicate HCV?
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