Hepatitis C Virus: HIV/Hepatitis C Coinfection Wednesday, August 24, 2016
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1 Hepatitis C Virus: HIV/Hepatitis C Coinfection Debika Bhattacharya, MD, MSc Associate Clinical Professor University of California Los Angeles Los Angeles, California Washington, DC: August 24, 2016 Slide 3 of 32 Learning Objectives After attending this presentation, participants will be able to: Describe hepatitis C virus (HCV) treatment regimens for HIV/HCV coinfection Describe HCV treatment regimens in special HIV/HCVcoinfected populations (including persons who are HCV treatment-experienced and those with cirrhosis) List key drug-drug interactions between HIV antiretroviral drugs and HCV antiviral drugs HCV/HIV Coinfection Liver disease accelerated 1 : 3x greater risk of progression to cirrhosis or decompensated liver disease ART seems to slow progression, but not fully 2 Hepatic Decompensation 4 Increased mortality (vs HCV and HIV monoinfection) 3 Therapy is effective: SVR associated with decreased rates of hepatic decompensation, hepatocellular carcinoma, and liver-related mortality 4 1 Graham et al, CID 2001;33:562-9, 2 Macias et al, Hepatology 2009;50: , 2 Ragni et al, Haemophilia 2009;15: , 2 Verma et al, BMC Res Notes. 2008;1:46, 1,2 AIDS Info Guidelines 2012, 3 Chen et al, CID 2009; 49: , 4 Mira JA et al, CID 2013;56: Slide 4 of 32 Debika Bhattacharya, MD, MSc 1
2 Slide 5 of 32 Direct Antiviral Agents - DAAs Drug Class Activity Potency Resistance Barrier Simeprevir Paritaprevir Grazoprevir GT 1,4 & 6 Daclatasvir Ledipasvir GT 1,4 NS5Ai Ombitasvir PI GT1 High Low GT 1,3 & 4 Elbasvir GT 1,4 & 6 Velpatasvir Sofosbuvir Dasabuvir NS5Bi Nucleotide NS5Bi Non-Nuc Pangenotypic High Low Pangenotypic Intermediate High GT1 Intermediate Low HIV/HCV Coinfection Pre-Treatment Questions HCV genotype/subtype Stage of fibrosis Cirrhosis - yes/no If yes, compensated? (e.g., ascites, encephalopathy, etc) Method? Liver biopsy Transient elastography Laboratory biomarkers Imaging Prior HCV treatment? Response? DAA used? Medications h/o of side effects Vaccination Status HIV status HIV drug resistance? Medications To check for drug interactions Interferon eligibility and/or willingness Comorbidities Patient preference Child-bearing potential of patient/partner Ribavirin is a teratogen Slide 6 of 32 Case 1 55 y.o. man with HIV/HCV, on EFV/TDF/FTC, no HIV failure hx HCV treatment naïve GERD on omeprazole 20 qd Physical examination unremarkable You obtain the following tests: Lab Lab/Test INR 1.1 HCV RNA 5,000,000 IU/mL Creatinine 0.9 mg/dl Total bilirubin 0.3 HCV genotype 1a AST 48 U/L WBC 4.58 x 10 3 /ul ALT 68 U/L Hemoglobin 14 g/dl Alkaline phosphatase 111 U/L Platelets 165,000 Albumin 4.1 US: increased echogenicity FIB-4 score 1.94 c/w chronic liver disease or fatty infiltration APRI 0.73 Slide 7 of 32 Debika Bhattacharya, MD, MSc 2
3 Slide 10 of 32 Treatment of HIV/HCV: USA No Cirrhosis GT Regimen Naive Experienced 1a Elbasvir/grazoprevir (+RBV with NS5A r) 12 wks 16 wks 12 wks (+ RBV*) 16 wks* LDV/SOF 12 wks 12 wks* PrOD 12 Wks (+RBV) 12 wks(+rbv) SMV+SOF 12 wks 12 wks DCV+SOF 12 wks 12 wks* SOF/VEL 12 wks 12 wks * 1b Elbasvir+grazoprevir 12 wks 12 wks (+ RBV*) LDV+SOF 12 wks 12 wks* PrOD 12 wks 12 wks SMV+SOF 12 wks 12 wks DCV+SOF 12 wks 12 wks* Note: Alternative regimens are listed in gray font, experienced refers to PR-experience, *recommended in 1 st gen PI+PR failures (Boceprevir/Telaprevir/Simeprevir) Drug/Drug Interactions Remain Critical in HIV/HCV Resources: University of Liverpool: AASLD/IDSA Guidance: Slide 11 of 32 SOF/LDV in HIV/HCV SOF/LDV for 12 weeks in HIV/HCV coinfected participants on ARV (n=335) *Note that 8 weeks was not studied ART included TDF/FTC + EFV, RAL, or RPV SVR12 96% overall but 10 relapses (all black patients with SVR12 of 91%) Key Points Ledipasvir needs acidic environment for absorption: DDI with proton pump inhibitors Ledipasvir increases plasma tenofovir levels Sofosbuvir and amiodarone coadministration contraindicated because of arrhythmias Sofosbuvir levels increased in renal insufficiency Slide 12 of 32 Debika Bhattacharya, MD, MSc 3
4 SVR12 (%) SOF/LDV in HIV/HCV No Role for 8 Wk Duration ALLY-2: HIV/HCV GT1: SOF/DCV for 8 or 12 wks in HCV Tx-naive ***HIV Coinfected Were Excluded Slide 13 of 32 Impact of PPI on SOF/LDV outcomes HCV-TARGET: SVR12 by Use of PPI at Baseline with LDV/SOF No PPI at baseline With PPI at baseline / 28/ 456/ 151/ Wks 12 Wks 13/732 Terrault AASLD 2015 Slide 14 of 32 Paritaprevir/ritonavir/ombitasvir/dasabuvir (PrOD) Trial Population Treatment Regimen PEARL-III 1 Phase III PEARL-IV 1 Phase III TURQUOISE-I 2 Phase II/III GT1b, Monoinfected, Tx-naïve GT1a, Monoinfected, Tx-naïve GT1, HIV/HCV, Tx-naïve GT1, HIV/HCV, Tx-exp PrOD+RBV x 12 weeks PrOD+RBV x 12 weeks PrOD+RBV x 12/24 weeks PrOD+RBV x 12/24 weeks SVR12 RBV+: 99.5% RBV-: 99% RBV+: 97% RBV-: 90% 12 wks: 95% 24 wks: 91% 12 wks: 91% 24 wks: 90% Key Points Need RBV for GT 1a Should not be used in Child s B/C cirrhosis Drug/Drug Interactions Co-administration with LPV/RTV results in 300 mg RTV C trough of ATZ, LPV increased, decreased for DRV Administration with EFV/TDF/FTC associated with increased GI and neuro side effects RPV exposures increased, risk for prolonged QT 1. Ferenci P NEJM 2014; 2. Sulkowski MS JAMA Slide 15 of 32 Debika Bhattacharya, MD, MSc 4
5 Slide 16 of 32 Grazoprevir/elbasvir FDA-Approved Indication - GT1 Population Treatment Duration Pivotal Trials GT1a TN or PR-TE Without NS5A RAVs GT1a TN or PR-TE With NS5A RAVs GT1b TN or PR-TE GT1a or 1b PR/PI - TE GZR/EBR 12 wks C-EDGE TN (N = 421) GZR/EBR + RBV GZR/EBR GZR/EBR + RBV 16 wks 12 wks GT1a = 92% SVR; GT1b = 99% SVR (HCV VL > 800,000; BL NS5A RAVs) C-SURFER [N = 122; stage 4/5 CKD (76% on HD)] SVR 94% C-EDGE COINFECTION GT1a= 97% GT1b=96% 12 wks C-SALVAGE (N = 79) 43% cirrhotic SVR 96% overall Key Points: Baseline NS5A Resistance testing for GT 1a Studied in CKD/dialysis Should not be used in Childs B/C Contraindicated with most HIV PIs AND EFV Should not be used with (OATP1B) inhibitors, strong inducers of cytochrome P450 3A (CYP3A) Impact of NS5A RAVS on GZR/EBR SVR12 (inclusive of TE and cirrhotics) SVR12 in HCV GT1a without or with Baseline NS5A Polymorphisms NS5A Polymorphism Status Without baseline NS5A polymorphism (M28, Q30, L31, Y93) With baseline NS5A polymorphism (M28*, Q30*, L31*, Y93*) GZR/EBR 12 Wks SVR12 % (n/n) GZR/EBR+RBV 16 Wks SVR12 % (n/n) 98 % (441/450) 100% (49/49) 70% (39/56) 100% (6/6) *Any change from GT1a reference Grazoprevir/Elbasvir Package Insert; 2016 Slide 17 of 32 ALLY-2: DCV+SOF HIV/HCV Coinfection GT 1 s Key Points Lower SVR rates with 8 wk regimen Daclatasvir dose adjustments Decrease to 30 mg with ATZ/r Increase to 90 mg with EFV or ETV Wyles DL, et al. N Engl J Med. 2015;373: Slide 18 of 32 Debika Bhattacharya, MD, MSc 5
6 Sofosbuvir/Velpatasvir: HIV/HCV ASTRAL-5 Study: GT1-6, HCV Tx Naïve or Experienced, 30% with compensated cirrhosis Key Points: Pan-genotypic Regimen VEL contraindicated with EFV; EFV decreases VEL levels VEL increases TDF levels, especially when used with a PK booster (ritonavir or cobicistat) No significant DDI between TAF and VEL Brau et al AIDS Conference 2016, Mogalian AASLD 2015, Mogalian IAS 2016 Slide 19 of 32 Sofosbuvir/Velpatasvir: DDI Velpatasvir and Efavirenz DDI Velpatasvir and Tenofovir DDI Mogalian AASLD 2015 Slide 20 of 32 Case 2 55 y.o. man with HIV/HCV, on DRV/r/TDF/FTC, no HIV failure hx HCV treatment-experienced, failed BOC/PR in 2013 Physical examination unremarkable You obtain the following tests: Lab/Test HCV RNA 5,000,000 IU/mL HCV genotype 1a WBC 4.58 x 10 3 /ul Hemoglobin 14 g/dl Platelets 100,000 US: Cirrhosis without lesions suspicious for HCC Lab INR 1.1 Creatinine 0.9 mg/dl Total bilirubin 0.3 AST 60 U/L ALT 68 U/L Alkaline phosphatase 111 U/L Albumin 4.1 FIB-4 score 4.00 APRI 1.5 Slide 21 of 32 Debika Bhattacharya, MD, MSc 6
7 SVR12 (%) SVR12 (%) SVR12 (%) Slide 24 of 32 Treatment of HCV: USA Cirrhosis GT Regimen Naive Experienced 1a Elbasvir+grazoprevir (+RBV with NS5A r) 12 wks 16 wks 12 wks(+rbv*) 16 wks* LDV+SOF (+RBV) 12 wks 24 wks* 12 wks* PrOD+RBV 24 wks 24 wks SMV+SOF (+RBV) 24 wks 24 wks DCV+SOF (+RBV) 24 wks 24 wks* SOF/VEL 12 wks 12 wks* 1b Elbasvir+grazoprevir 12 wks 12 wks(+rbv)* LDV+SOF (+RBV) 12 wks 24 wks* 12 wks* PrOD 12 wks 12 wks SMV+SOF (+RBV) 24 wks 24 wks DCV+SOF (+RBV) 24 wks 24 wks* SOF/VEL 12 wks 12 wks* Note: Alternative regimens are listed in gray font, experienced refers to PR-experience, *recommended in 1 st gen PI failures Phase III Studies of Sofosbuvir + Ledipasvir ± RBV in GT1 HCV ION-2: GT1 treatment-experienced pts (20% cirrhotic): SOF/LDV FDC ± RBV x 12/24 wk SOF/LDV FDC No Cirrhosis SOF/LDV FDC + RBV Cirrhosis / 107/ 108/ 110/ Wks 24 Wks ION-2: Afdhal N et al, NEJM 2014;370: Ledipasvir/sofosbuvir [package insert] Slide 25 of / 19/ 85/ 22/ Wks 24 Wks SIRIUS study: SOF/LDV Double-blind, TE cirrhotic (all failed PR AND PI/PR) 100 SOF/LDV FDC x 24 wks SOF/LDV FDC + RBV x 12 wks Bourliere Lancet ID 2015 Slide 26 of Debika Bhattacharya, MD, MSc 7
8 SOF/LDV TDF and TAF Drug Drug Interactions TDF: LDV increases TFV Cmax 47-64% with boosted PI regimens TAF: LDV increases TFV exposure with TDF-containing regimens but TFV AUC tau is ~5 lower with TAF-, when compared to TDF- containing regimens. SOF/VEL TDF: VEL increases TFV exposure by 20-81% with TDF containing regimens TAF: No significant impact on TFV levels German CROI 2015, Mogalian AASLD 2015, Custodio IDSA 2015 Slide 27 of 32 Case 3 55 y.o. man with HIV/HCV, on EFV/TDF/FTC, no HIV failure hx, cirrhosis Failed SOF/LDV+RBV x 12 weeks Physical examination unremarkable You obtain the following tests: Lab/Test HCV RNA 5,000,000 IU/mL HCV genotype 1a WBC 4.58 x 10 3 /ul Hemoglobin 14 g/dl Platelets 100,000 US: Cirrhosis without lesions suspicious for HCC Lab INR 1.1 Creatinine 0.9 mg/dl Total bilirubin 0.3 AST 60 U/L ALT 68 U/L Alkaline phosphatase 111 U/L Albumin 4.1 FIB-4 score 4.00 APRI 1.5 Slide 28 of 32 Recommendations for NS5A Failures GT 1: Deferral of treatment (non-cirrhotic) Test for resistance-associated variants that decrease susceptibility to NS3 PIs and NS5A inhibitors (cirrhotic or who require urgent treatment) Nucleotide-based dual DAA (24 wks, + RBV unless contraindicated) If available, nucleotide-based triple or quad DAA regimens may be considered (12 or 24 wks, +RBV) AASLD/IDSA HCV Treatment Guidance Slide 29 of 32 Debika Bhattacharya, MD, MSc 8
9 Resistance Associated Variants (RAVs) Slide 30 of 32 Resistance Associated Variants (RAVs) Slide 31 of 32 Summary HCV cure is associated with reductions in mortality in HCV and HIV/HCV coinfection SVR12 rates are similar in HIV/HCV coinfection 8 week regimens should not be used with currently available medications in HIV coinfection HCV protease inhibitors are contraindicated in Childs B/C cirrhosis Drug-Drug interactions are important in HIV/HCV Slide 32 of 32 Debika Bhattacharya, MD, MSc 9
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