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SVR with Telaprevir, Peginterferon Alfa-2A and Ribavirin in HCV

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SVR with Telaprevir, Peginterferon Alfa-2A and Ribavirin in HCV The Pharmacokinetics of Telaprevir and Selected ART Medications in HCV/HIV Co-infected Patients Analysis of Phase 2 Telaprevir Study 110 Joshua Henshaw,1 Lisa Mahnke,1 Bambang Adiwijaya,1 Nathalie Adda,1 Raymond Rubin,1 Mark S. Sulkowski,2 Varun Garg1 1. Vertex Pharmaceuticals Incorporated, Cambridge, MA, USA; 2. Johns Hopkins University School of Medicine, Baltimore, MD, USA Disclosures for all Authors J Henshaw, B. Adiwijaya, and N. Adda are former employee of Vertex Pharmaceuticals and may own stock or stock options L Mahnke, R Rubin, and V Garg are employees of Vertex Pharmaceuticals and may own stock or stock options Mark Sulkowski has received consulting/lecture fees from Abbott, Anadys Pharmaceuticals, Biolex, Boehringer Ingelheim, Gilead Sciences, Human Genome Sciences, Merck, Pharmasset, Roche/Genentech, Tibotec and Vertex Pharmaceuticals and Grant/Research Support form Abbott, Achillion, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, Merck, Pharmasset, Roche and Tibotec; Advisory or Review Committee Member: Abbott, Achillion, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, Merck & Co., Pfizer, Roche and Tibotec Background Telaprevir (TVR, T) in combination with peginterferon (Peg-IFN, P) and ribavirin (RBV, R) is approved for treatment of genotype 1 chronic HCV infection in adults with compensated liver disease Drug-drug interactions between TVR and antiretroviral therapy (ART: EFV, ATV/r, TDF) have been evaluated in Phase 1 studies in healthy volunteers In this Phase 2 study, PK of TVR and ART’s was evaluated across treatment combinations of TVR with EFV- or ATV/r- based regimens in HCV/HIV co-infected patients Study Design: *US NIH Clinical Trials Identifier: NCT00983853 †HIV type 1 ‡ATV/r based ART includes Atazanavir, Ritonavir, and Tenofovir. EFV-based ART includes Efavirenz and Tenofovir SVR Rates 12 Weeks Post Treatment (SVR12)* 100 90 80 80 74 71 69 70 60 50 50 50 45 40 33 Patients with SVR SVR (%) withPatients 30 20 10 0 n/N = 5/7 11/16 12/15 28/38 2/6 4/8 4/8 10/22 T/PR PR No ART EFV ATV/r Total Patient was defined as SVR12 if HCV RNA was < LLOQ in the visit window *Dieterich et al. Conference on Retroviruses and Opportunistic Infections, Seattle, Washington; 2012 Presented at CROI – March 6, 2012 Viral Breakthroughs There were no HIV RNA breakthroughs 2 T/PR patients experienced HCV RNA breakthrough: – 1 receiving ATV/r-based therapy at Week 4 – 1 receiving EFV-based therapy at Week 12 Comparison of Telaprevir Steady-state Concentration by ART regimens Comparison Parameter GLS mean ratio [90% CI] Cmin Ratio 88.4 [54.7, 143.0] EFV-Based ART C Ratio 96.1 [66.2, 139.6] vs. No ART avg Cmax Ratio 100.6 [73.01, 138.6] Cmin Ratio 130.6 [79.8, 213.7] ATV/r-Based ART vs. No C Ratio 109.3 [74.6, 160.2] ART avg Cmax Ratio 100.8 [72.6, 139.8] Pharmacokinetics of ART During and Before HCV Treatment in HCV/HIV Co-infected Patients* In HCV/HIV Co-infected Patients ART Median Cmin before HCV Median ratio of Cmin During:Before Medication Treatment (ng/mL) HCV Treatment +T/PR +PR +T/PR +PR Atazanavir (ATV) 962 1280 116% 103% Efavirenz (EFV) 1320 1700 94% 79% Tenofovir (+EFV) 51.2 73.9 106% 64% Tenofovir (-EFV) 128 124 75% 93% TVR exposure and Key Virologic Endpoints (RVR, eRVR) TVR Plasma Concentration TVR exposure and Key Virologic Endpoints (RVR, eRVR) RVR by TVR eRVR by TVR Safety: TVR or Tenofovir Exposure and Creatinine Clearance TVR Exposure Tenofovir Exposure R = .035 R = .359 Pooled Tenofovir data from EFV- and ATV/r-based therapies Pooled Pbo, PR and TVR arms Safety: TVR or ATV Exposure and Indirect Bilirubin TVR Exposure ATV Exposure R = .098 R = .262 Pooled Pbo, PR and TVR arms Pooled Tenofovir data from EFV- and ATV/r-based therapies Conclusions Overall, SVR12 was achieved in 74% of patients receiving TPR treatment and 45% of patients receiving PR treatment Telaprevir exposures were comparable across no ART and ART treatments Telaprevir coadministration did not result in clinically significant changes in concentrations of ART medications In patients treated with telaprevir combination treatment, creatinine clearance and indirect bilirubin levels were not strongly correlated with telaprevir exposure Acknowledgements We thank all the Study 110 trial patients and investigators Medical writing and editorial coordination was provided by Mrudula Donepudi, PhD, Elizabeth Dorn, PhD, and Valerie Philippon, PhD. Graphic design support was provided by Jonathan Kirk .
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