Tough Cases in HIV/HCV Coinfection
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1 NORTHWEST AIDS EDUCATION AND TRAINING CENTER Tough Cases in HIV/HCV Coinfection John Scott, MD, MSc Assistant Professor University of Washington Presentation prepared by: J Scott Last Updated: Jun 5, 2014
2 Disclosures In the past year, JS has served on Advisory Boards for Gilead and Tibotec/Janssen; and received grant funding for clinical trials from Genentech, Merck, and Vertex. JS serves on the DSMB for Tacere Therapeutics, Inc
3 Objectives To discuss the pros/cons of treating Hep C now vs. waiting To know the efficacy for using SMV/SOF for coinfected patients
4 Case 1 55 yo W man, coinfected with HIV/HCV wants to know if he should be treated for HCV. Diagnosed with HIV in 1990, nadir CD4 100, on ARVs w/ good suppression for last 15 yrs. Now on RAL + TDF/FTC w/ CD4 of 500 and HIV <15 c/ml. Diagnosed with HCV 1995, never treated before. GT 1a, HCV RNA 1 million IU/ml. Liver Bx 2012: F4 INR 1.1, TB 0.7, Cr 0.8, plt 100, alb 3.6 Never had decompensation, no ascites Otherwise in good health: no DM, CAD, CKD or significant psych issues.
5 Survey: What would you recommend? A. Treat now with Peginterferon + Ribavirin + Sofosbuvir x 12 wks B. Treat now with Sofosbuvir + Simeprevir x 12 wks C. Treat now with Sofosbuvir + Simeprevir + RBV x wks D. Treat now with Sofosbuvir + RBV x 24 wks E. Wait for SOF/LDV or other non-ifn based therapy in next 12 mos URL: Code: uwecho
6 FDA label for Sofosbuvir (Sovaldi) GT 2 and 3 naives GT 2 and 3 intolerant or non-responders GT 1,4 naives and P/R failures (non-decompensated cirrhotics and non-cirrhotics) Patients with HCC and awaiting liver txp Both HIV+ and HIV-
7 Dosage and Duration 400 mg tablet once daily No food effect SOVALDI in combination with ribavirin for 24 weeks can be considered for CHC patients with genotype 1 infection who are interferon ineligible. GT1: naïve, P/R failures, HIV+/- SOF, PegIFN, & RVN SOF/RBV 12 weeks - GT 2: naïve or P/R failures - 12 wks GT 3: naïve or P/R failures - 24 wks HCC, awaiting OLT 48 wks
8 Sofosbuvir and Ribavirin for HCV-HIV Coinfection PHOTON-1 Trial: Study Features PHOTON-1 Trial: Features Design: Randomized, controlled, open-label, phase 3, non-inferiority trial using sofosbuvir + ribavirin in HCV-HIV and GT 1, 2, 3 Setting: United States and Puerto Rico Entry Criteria - HIV coinfection; HCV Genotype 1, 2, or 3 - Treatment naïve or treatment experienced - Compensated cirrhosis permitted; no platelet cutoff - CD4 200 if on stable ARV therapy; CD4 500 if no ARV therapy - Stable antiretroviral therapy = HIV RNA < 50 copies/ml > 8 weeks Patient Characteristics - N = 182 HCV-HIV coinfected patients - Baseline mean CD4 count: range cells/mm 3 - On ARV Rx: GT1 (98%); GT/32 naive (90%); GT/32 experienced (95%) Primary End-Points: Efficacy (), safety, and impact on HIV Source: Naggie S, et al. 21 st CROI. 2014: Abstract 26. Slide courtesy of D. Spach
9 HIV/HCV Coinfected Patients: PHOTON-1 GT 1 TN!! GT 2,3 TN!! GT 2,3 TE! 0 12 wk 24wk! SOF + RBV N=114 SOF + RBV N=68 SOF + RBV N=41 Wide range of ARVs permitted Compensated cirrhotics permitted HIV RNA had to be undetectable for at least 8 wks CD4 >200 cells/ml if on ARVs or >500 cells/ml if untreated MS Sulkowski, et al. Abstract 212, The Liver Meeting AASLD 2013, Wash DC.
10 Sofosbuvir and Ribavirin for HCV-HIV Coinfection PHOTON-1 Trial: Results 100 Patients (%) with SVR Genotype 1 Genotype 2 Genotype 3 Genotype 2 Genotype 3 24-week Rx Treatment Naive 12-week Rx 24-week Rx Treatment Experienced Source: Naggie S, et al. 21 st CROI. 2014: Abstract 26.
11 Sofosbuvir + Simeprevir +/- Ribavirin for HCV GT 1 COSMOS Trial: Study Features COSMOS Trial: Features Design: Randomized, phase 2a, open-label, using sofosbuvir + simeprevir +/- ribavirin in treatment naive or experienced, chronic HCV GT 1 Setting: United States and Europe Entry Criteria - Chronic HCV Genotype 1 - Cohort 1: prior null responders; Metavir F0-F2 - Cohort 2: treatment naïve & prior null responders; Metavir F3-F4 Patient Characteristics (range in different treatment arms) - N = 167 (n = 80 in Cohort 1 and n = 87 in Cohort 2) - Baseline GT1a with Q80K: Cohort 1 = 50%; Cohort 2 = 40% - Non-CC IL28b Genotype: Cohort 1 = 94%; Cohort 2 = 79% End-Points: Primary = ; Secondary = safety Source: (Cohort 1) Sulkowski M, et al. 49 th EASL. April Abstract 07. (Cohort 2) Lawitz E, et al. 49 th EASL. April Abstract 165.
12 Sofosbuvir + Simeprevir +/- Ribavirin for HCV GT 1 COSMOS Trial: Design for Cohort 1 Cohort 1: Prior Null Responders; Metavir Scores F0-F2 Week N =24 SOF + SMV + RBV N =15 SOF + SMV N =27 SOF + SMV + RBV N =14 SOF + SMV Drug Dosing SOF= Sofosbuvir: 400 mg once daily SMP =Simeprevir: 150 mg once daily RBV = Ribavirin (weight-based and divided bid): 1000 mg/day if < 75 kg or 1200 mg/day if 75 kg Source: Sulkowski M, et al. 49 th EASL. April Abstract 07.
13 Sofosbuvir + Simeprevir +/- Ribavirin for HCV GT 1 COSMOS Trial: Results for Cohort 1 COSMOS (Cohort 1): SVR 12 by Regimen Patients with SVR 12 (%) /24 14/15 26/27 13/14 SOF + SMV + RBV SOF + SMV (24 weeks) (24 weeks) 24-Week Treatment SOF + SMV + RBV SOF + SMV (12 weeks) (12 weeks) 12-Week Treatment SOF = sofosbuvir; SMV = simeprevir; RBV = ribavirin Source: Sulkowski M, et al. 49 th EASL. April Abstract 07.
14 Sofosbuvir + Simeprevir +/- Ribavirin for HCV GT 1 COSMOS Trial: Design for Cohort 2 Cohort 2: Treatment Naïve & Prior Null Responders; Metavir Scores F3-F4 Week N =30 SOF + SMV + RBV N =16 SOF + SMV N =27 SOF + SMV + RBV N =14 SOF + SMV Drug Dosing Sofosbuvir: 400 mg once daily Simeprevir: 150 mg once daily Ribavirin (weight-based and divided bid): 1000 mg/day if < 75 kg or 1200 mg/day if 75 kg Source: Lawitz E, et al. 49 th EASL. April Abstract 165.
15 Sofosbuvir + Simeprevir +/- Ribavirin for HCV GT 1 COSMOS Trial: Results COSMOS (Cohort 2 with F3-F4 Fibrosis): 100 by Regimen 100 Patients with SVR 12 (%) SOF + SMV + RBV SOF + SMV (24 weeks) 24-Week Treatment (24 weeks) /30 16/16 25/27 13/14 SOF + SMV + RBV SOF + SMV (12 weeks) 12-Week Treatment (12 weeks) SOF = sofosbuvir; SMV = simeprevir; RBV = ribavirin Source: Lawitz E, et al. 49 th EASL. April Abstract 165.
16 The Coming Pipeline for HCV Protease Inhibitors: - 2 nd Generation: MK 5172 (2015) in conjunction with MK 8742 (NS5a) - ABT 450/ritonavir (Nov 2014) - Asunaprevir (Dec 2014) NS5a Inhibitors - Daclatasvir (Dec 2014), Ledipasvir + SOF (Oct 2014), ABT 267 ombitasvir (Nov 2014) Non-nucleoside inhibitors - ABT 333 dasabuvir (Nov 2014)
17 Sofosbuvir + Ledipasvir Phase 3 Studies ION-1 Trial Design: Open-label, randomized, phase 3, using fixed-dose combination of ledipasvir-sofosbuvir +/- ribavirin in treatment-naïve patients with GT1 HCV Setting: 99 sites in United States and Europe Entry Criteria - Chronic HCV Genotype 1 (n = 865) - HIV negative; 18 years or older - No prior HCV treatment - Patients with cirrhosis accepted (up to 20% of patients) Primary End-Point: Source: Afdhal N, et al. N Engl J Med. 2014;370:
18 Ledipasvir-Sofosbuvir +/- Ribavirin in Treatment-Naïve HCV GT 1 ION-1 Study: Study Design Week GT-1 Naive n = 214 n = 217 LDV-SOF LDV-SOF + RBV GT-1 Naive n = 217 n = 217 LDV-SOF LDV-SOF + RBV Drug Dosing Ledipasvir-sofosbuvir N =14 (90/400 mg): fixed dose combination; one pill once daily Ribavirin (weight-based and divided bid): 1000 mg/day if < 75 kg or 1200 mg/day if 75 kg Abbreviations: LDV= ledipasvir; SOF = sofosbuvir; RBV = ribavirin Source: Afdhal N, et al. N Engl J Med. 2014;370:
19 Ledipasvir-Sofosbuvir +/- Ribavirin in Treatment-Naïve HCV GT 1 ION-1 Study: Results ION-1: SVR 12 by Treatment Duration and 100 Regimen Patients with SVR 12 (%) / / / /217 LDV-SOF LDV-SOF +RBV LDV-SOF LDV-SOF + RBV 12-Week Regimen 24-Week Regimen LDV= ledipasvir; SOF = sofosbuvir; RBV = ribavirin Source: Afdhal N, et al. N Engl J Med. 2014;370:
20 Ledipasvir-Sofosbuvir +/- Ribavirin in Treatment-Naïve HCV GT 1 ION-1 Study: Results ION-1: by Treatment Regimen and Liver Without Cirrhosis With Cirrhosis Disease Patients (%) with SVR /179 32/33 178/178 33/33 181/182 31/32 179/179 36/36 LDV-SOF LDV-SOF + RBV LDV-SOF LDV-SOF + RBV Week Treatment 24-Week Treatment Source: Afdhal N, et al. N Engl J Med. 2014;370:
21 Treat Now or Wait? Treat Now: 80-90% chance of cure right now Insurance will likely pay for it Side effects from IFN/ RBV are not as major a consideration with 12 wks Treat Later: 90-95% chance of cure in next year Better tolerated Insurance will still likely pay for it Stay tuned! HCV Guidelines from IDSA/AASLD to address decision of when to treat late Jun/early July 2014!
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