Real-life results of triple therapy with the combination of sofosbuvir-pegylated interferon-ribavirin for Egyptian patients with hepatitis C

Transcription

1 Real-life results of triple therapy with the combination of sofosbuvir-pegylated interferon-ribavirin for Egyptian patients with hepatitis C Prof. Gamal Esmat Prof. Hepatology & Vice President of Cairo University, Egypt Member of WHO Strategic Committee for Viral Hepatitis

2 G Esmat 1, W Elakel 1, M Elserafy 1, A Yosry 1, A Omar 1, W Doss 1, I Waked 2, MH Elsayed 3, Z Mahran 3, M Makhlouf 3, Y Elshazly 3, N Elgarem 1, A Gaballa 1, K Kabil 4, M Hassany 5 1 Cairo University, Cairo, Egypt, 2 National Liver Institution, Menoufia, Egypt, 3 Ain Shams University, Cairo, Egypt, 4 National Committee for Control of Viral Hepatitis, Cairo, Egypt, 5 National Hepatology and Tropical Medicine Research, Cairo, Egypt

3 Global prevalence &genotype distribution

4 Prevalence of HCV in Egypt Socioeconomic characteristic Urban-rural residence Urban Rural Place of residence Urban Governorates Lower Egypt Urban Rural Upper Egypt Urban Rural Frontier Governorates Education No education Some primary Primary complete/some secondary Secondary complete/higher Wealth quintile Lowest Second Middle Fourth Highest HCV antibody positive, % Total 14.7 El-Zanaty F & Way A. Egypt Demographic & Health Survey 2008

5 National Survey (DHS) 2015 (1-59 years) 2015(1-59 Y) HCV Ab 6.3% HCV PCR 4.4%

6 Egypt faces the largest burden of HCV infection in the world, and infection is predominantly with genotype 4. Triple therapy with sofosbuvir (SOF), pegylated interferon (PEG) and ribavirin (RBV) has shown very high sustained virological response (SVR) rates in clinical trials that included HCV-genotype 4 patients. Its introduction in late 2014 in a national treatment program marked the beginning of a new era in HCV therapy in Egypt. The real-life results of this therapy for HCV genotype 4 is not known.

7 SVR12 (%) Resource-limited settings: the Egyptian example Gilead access program 100 reduced 100 cost drastically National treatment program started October by SOF based therapy 60 SOF-PEG-RBV 12 40wks for IFN eligible patients (triple therapy) 20 SOF-RBV 24 weeks for IFN-ineligible patients(dual therapy) 0 DCV PEG-RBV wks SMV PEG-RBV Naiive wks SMV PEG-RBV Experienced wks 96 SOF PEG-RBV 12 wks 100 SOF RBV 24-wks Naiive 87 SOF RBV 24wks Experienced 738,000 registered for evaluation 95 Of them were 100 evaluated ,000 F3 and F4 selected for treatment 20% 15,000 started treatment, 33% SOF+PEG-RBV 67% SOF+RBV By the end of 2014, 899 patients received triple therapy were included in this analysis and have currently LED SOF reached PAR/r-OBM12PAR/r-OMB weeks PAR/r-OMB after the ASV+BCV+DCV end 12 wks RBV Naiive RBV Experienced of therapy. 1. He zode C, et al. Gut, Moreno, C., et al. J Hepatol, 2014, 3. Lawitz, E., et al. N Engl J Med, Ruane P et al. EASL 2014, 5. Esmat G el al. AASLD 2014, 6. Kapoor et al. AASLD 2014, 7. Pol S. et al. Hepatology 2014

8 Outcome of treatment of 899 patients (F3&F4 compensated) with Triple therapy 4 pts 4 pts 899 triple therapy 2 pts stopped due to severe anemia 5 pts stopped due to hepatic decompensation 1 mortality (esophageal bleeding) 8 DC ETR 96% 27 positive viremia 864 negative viremia SVR 86% 91 positive viremia (relapser) 773 Negative viremia

9 Relapse rate 11% DC, 8 Positive, 91 NA, 27 SVR 86% Negative, 773

10 Demographic features of the studied patients SVR (n=773) non SVR (n=126) P value Gender M/F 496/277 84/ Age Mean ±SD 52.8± ± BMI Mean ±SD 28.7±4 29.4±4.116 DM No (%) 97 (13%) 21 (17%) 0.20 Treatment Experienced No (%) 285 (37%) 57 (45%).073

11 Baseline lab results SVR non SVR P value Mean SD Mean SD ALT AST log_10_baseline_viremia AFP (IU/L) Albumin (g/dl) Total BILIRUBIN (mg/dl) Indirect Bilirubin (mg/dl) TSH WBCx10^3/mm^ ANCx10^3/mm^ Hb (G/L) plateletsx10^3/mm^ PC (%) INR Creatine (mg/dl)

12 95% CI for predictor for failure of treatment in the 899 studied patients Age ALT T exp AFP Albumin Hb LC

13 SVR in the studied patients SVR Overall (n=899) previous treatment (n=342) cirrhotic (n=479) 80 Varices (n=166) Splenomegaly (n=414) Fib-4 >3.25 (n=445)

14 No of patients Reported Side effects sideeffects, no side effects, Presence of side effects is significantly associated with failure of treatment (OR 1.4, P 0.02) 0 week 1 week 2 week 4 week 12

15 No of patients Reported Side effects week 1 week 2 week 4 week 12 W1 W2 W4 W12 Pseudo-Flu syndrome Others RASH Amnesia GI symptoms Hair Loss Respiratory Disorders

16 Conclusion This interim report of real-life nationwide treatment campaign using SOF-PEG-RBV in patients with advanced fibrosis showed a high SVR rate. Lower serum albumin level is the only predictor of no SVR. More real- life data for both the triple therapy and dual therapy will be available in the next meeting.

17 THANK YOU Nile River in Cairo