How to improve the access to therapy in South and East: Romania. Mihai Voiculescu. Romania
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1 How to improve the access to therapy in South and East: Romania Mihai Voiculescu Romania
2 2 mil. Habitants; 5.6% HCV prevalence 99.5% GT1b 15 Internal Gross Revenue - Romania 124,7 139,7 132,6 131,5 124,1 118,3 139, ,8,717 Internal Gross Revenue EU 79,3 97,8 6 Romania Mld Euro Million Euro EU 2,49,1 1,97,1 1,566,7 1,52,8 1,51,1 57,2 337,2 115,8 GermanyFrance UK Italy Spania Holand Belgia Romania - Romania was fnancially exhausted and afected by poverty afer the collapse of the communist regime. The budget allocated to Healthcare system was constantly low (4.5%), a refecton of a reduced Internal Gross Revenue comparing to Western countries (2 3 tmes less). - Bureaucracy and poor management of resources amplifed dramatcally the defcit. - Romania is one among other European countries where detecton, preventon and treatment policies on viral hepatts were implemented with a delay.
3 IFN PEG-IFN + RBV PEG-IFN + RBV Bocepriv or Telaprevir 35 patients 1994 starts INF therapy: 4. patents 21 starts PEG INF + RIBA: 26. patents / 1 years In 213 The European Liver Patients Association (ELPA) has commissioned the independent Swedish Institute for Economic Analysis Quantify Research to conduct a study which estimates the economic burden of HCV in Romania and make recommendations. (Thanks to Achim Kautz and M. Voiculescu who provided the data). 213 PI first generation 35 patients. IFN free Exviera + Viekirax + RIBA 5 patients 215 Start the IFN free therapy with Exviera and Viekirax for 5 patients. For the moment, Government Insurance Fund provides funding only for treatment of patients with advanced fibrosis (F4). We expect very soon to extend the indication to F3. Until now 123 patients complete the tests, but only 75 were considered eligible.
4 Solutions to increase the patient s access to treatment a better government funding; goals efficiency by defning priorites and methodologies. better regional coordinaton concerning the screening of the diseases; simplifying and cost-accessibility of the detecton and treatment measure results and implement correctve actons keeping the politcal decidents constantly aware in order to improve the system especially under the circumstances of the extended immigraton.
5 Join us at or
6 Traitements des patients atteints de cirrhose
7 1. Quelle sont les bénéficies réele d'un traitement antivirale pour les patients atteints de cirrhose hépatique? 2. Dans tout les cas les patients atteints de cirrhose hépatique doivent-eux recevoir une thérapie antivirale? 3. Pour les patients atteints de cirrhose hépatique le rapport risque/ bénéfices justifie-t-il un traitement antivirale? 4. RBV est elle nécessaire dans le traitement de patients atteints de cirrhose?
8 TRIO: real-world analysis of predictors of DAA-based Tx failure in GT1 HCV Data obtained on GT1 HCV from Trio Health program Includes pts with GT1 HCV who received 12-wk LDV/SOF, OBV/PTV/RTV + DSV, or SMV + SOFbased Tx 1/214-3/215 (N = 1685) Factors Associated With Lower SVR Rate P Value Platelet count < K/mL <.1 SVR12 (%) 6 4 Cirrhosis <.1 Prescribing outside of FDAapproved labeling* <.1 2 n/n = 1432/ 1521 LDV/SOF 74/ 76 LDV/SOF ± RBV 32/ 41 SMV + SOF 43/ 47 OBV/PTV/ RTV + DSV ± RBV Male sex.8 *149/1685 pts treated outside of FDA-approved labeling. Afdhal NH, et al. AASLD 215. Abstract LB-17. Reproduced with permission.
9 Virologic Efficacy No virologic failures or AE-related discontinuations 12-wk DCV + SOF + RBV 16-wk DCV + SOF + RBV SVR12 (%) n/n = 21/ 24 All Pts 24/ 26 6/ 6 8/ 8 Advanced Fibrosis (F3) 15/ 18 16/ 18 Cirrhosis 14/ 16 12/ 14 Cirrhosis + Treatment Experienced Leroy V, et al. AASLD 215. Abstract LB-3. Reproduced with permission.
10 Interim Analysis: Daclatasvir + Sofosbuvir ± RBV in GT3 HCV in French CUP Pts treated with DCV 6 mg + SOF 4 mg QD for 24 wks; RBV added or duration shortened to 12 wks per physician discretion Most common AEs: asthenia, sleep disorder, headache Tx-related serious AEs (n = 1 each): hepatic decompensation, allergic dermatitis SVR12 (%) n/n = 81 47/ 58 5/ 5 DCV + SOF / / / 33 4/ 4 DCV + SOF + RBV 12 wks 24 wks 12 wks 24 wks 12 wks 24 wks All Pts Cirrhosis No Cirrhosis / / / 25 1/ 1 29/ 29 4/ 5 Hezode C, et al. AASLD 215. Abstract 26. Reproduced with permission.
11 Interim Analysis of French CUP: SVR12 by Child-Pugh Score Child-Pugh A Child-Pugh B or C SVR12 (%) / 3 2/ 6 DCV + SOF ± RBV 12 Wks 9/ 12/ 17 DCV + SOF 24 Wks 28/ 33 7/ 1 DCV + SOF + RBV 24 Wks Hezode C, et al. AASLD 215. Abstract 26. Reproduced with permission.
12 HCC risk after SVR With PegIFN ± RBV Retrospective VA cohort study of HCV-infected pts treated with pegifn ± RBV from (N = 22,28) HCC incidence rate 3.27/ PY with SVR vs 13.2/ PY without SVR (HR:.358) Predictor of HCC Following SVR* HR (95% CI) P Value Cirrhosis at time of SVR 4.45 ( ) <.1 Age at SVR, yrs (vs younger than 55 yrs) ( ).2 65 or older 4.69 ( ).3 Diabetes 2.7 ( ).1 HCV GT (vs GT1) 2.56 ( ).522 *Cox proportional hazards model adjusted for competing risk of death ( ).131 El-Serag HB, et al. AASLD 215. Abstract 9. Reproduced with permission.
13 Elbasvir/Grazoprevir in compensated Cirrhosis: pooled analysis of Ph II/III data Includes pts with Child-Pugh A cirrhosis and GT1, 4, or 6 HCV who received elbasvir/grazoprevir ± RBV in phase II/III trials Treatment-naive pts treated for 12 wks (n = 169) Treatment-experienced pts treated for 12, 16, or 18 wks (n = 233) FAS: all randomized pts who received 1 dose of drug Modified FAS: FAS, excluding pts who discontinued for reasons unrelated to study drug HCV Genotype, n (%) Pts (N = 42) 1a 219 (54.5) 1b 152 (37.8) 1 other 5 (1.2) 4 23 (5.7) 6 3 (.8) Jacobson IM, et al. AASLD 215. Abstract 42.
14 SVR12 (%) SVR12 (%) n/n = n/n = Elbasvir/Grazoprevir in compensated Treatment Naive Pts; 12 Wks (FAS) 98 9 No RBV / / / 81 Cirrhosis: SVR12 RBV 46/ 49 28/ 31 Treatment Experienced Pts (FAS) 49/ 49 No RBV RBV No RBV RBV 12 wks 16 or 18 wks Treatment-naive pts: SVR12 rates similar regardless of RBV use, HCV subtype in FAS and regardless of platelets, cirrhosis determination method, FibroScan score in mfas SVR12 rate range across subgroups treated without RBV: 96% to % Previous relapsers (mfas): SVR12 rates not affected by treatment duration or RBV use Previous nonresponders (mfas): SVR12 rates lower with 12-wk, no RBV vs 16/18-wk, + RBV treatment GT1: 92% vs % GT4: 67% vs % Jacobson IM, et al. AASLD 215. Abstract 42. Reproduced with permission.
15 Elbasvir/Grazoprevir in compensated Cirrhosis: safety Safety Outcome (FAS), % Elbasvir/Grazoprevir (n = 264) Elbasvir/Grazoprevir + RBV (n = 193) Drug-related AE Serious AE Serious drug-related AE.4 Discontinuation for AE Discontinuation for lab abnormality*.4 Death.4.5 AEs in > 1% pts Fatigue Headache Nausea *ALT elevation with increased eosinophils. Coronary artery disease (n = 1), car accident (n = 1). Jacobson IM, et al. AASLD 215. Abstract 42. Reproduced with permission.
16 ASTRAL-2 open-label trial: SVR12, safety with Sofosbuvir/Velpatasvir in GT2 HCV No impact of BL NS5A RAVs on SVR rates Safety profile similar to ASTRAL-1 P =.18 (superiority) Treatment Naive SOF/VEL 12 wks SOF + RBV 12 wks Treatment Experienced SVR12 (%) n/n = 133/ / / 92/ 96 15/ 15 All Pts No Cirrhosis Cirrhosis No Cirrhosis Cirrhosis 14/ 15 15/ 15 13/ 16 4/ 4 4/ 4 Sulkowski MS, et al. AASLD 215. Abstract 25. Reproduced with permission. Foster GR, et al. N Engl J Med. 215;[Epub ahead of print].
17 ASTRAL-3 open-label trial: SVR12, safety with Sofosbuvir/Velpatasvir in GT3 HCV SVR12 rate numerically lower with vs without BL NS5A RAVs (88% vs 97%) Safety profile similar to ASTRAL-1 P <.1 (superiority) SOF/VEL 12 wks SOF + RBV 24 wks 9 63 SVR12 (%) n/n = 264/ / / / / All Pts No Yes Naive Experienced Cirrhosis 55/ 83 2/ / 24 64/ 71 Treatment History 45/ 71 Mangia A, et al. AASLD 215. Abstract 249. Reproduced with permission. Foster GR, et al. N Engl J Med. 215;[Epub ahead of print].
18 QUARTZ-I: OBV/PTV/RTV + DSV + SOF ± RBV for DAA-Exp d pts with GT1 HCV Multicenter, open-label, phase II study Previous Tx: 73% OBV/PTV/RTV ± DSV; 9% TPV + PR; 9% SOF + RBV or SOF + PR; 4.5% SMV + SOF; 4.5% SMV + samatasvir + RBV Majority of AEs mild to moderate 2 serious AEs not related to study drugs (pneumonia and cellulitis) 1 grade 3 ALT elevation resolved by EOT without treatment interruption Wk 12 Wk 24 SVR12, % Noncirrhotic GT1a pts Cirrhotic GT1a pts GT1b pts ±cirrhosis OBV/PTV/RTV + DSV + SOF + RBV (n = 14) OBV/PTV/RTV + DSV + SOF + RBV (n = 6) OBV/PTV/RTV + DSV + SOF (n = 2) 92 OBV/PTV/RTV 25/15/ mg QD + DSV 25 mg BID; SOF 4 mg QD; weight-based RBV. Poordad F, et al. AASLD 215. Abstract LB-2.
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