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DECEMBER-,)9 <(20149@ ISSUE0::<, 1(:6/(77(5 DECEMBER-,)9<(9@ 20140::<, ISSUE A review of new data on the treatment of chronic hepatitis C presented at The Liver 7KMeetingH,QWHUQDW 2014LRQDO /LYHU&RQJUHVV WK Alessio Aghemo M.D. PhD Fondazione $SULO IRCCS/RQG Ca’ GrandaRQ Ospedale Maggiore Policlinico I`7YVMLZZVY4HYR\Z7LJR9HKVZH]SQL]PJ di Milano, Milan, Italy and EASL:LJYL[ GoverningHY`.LULYHSVM[ OL,Board\YVWLHU(ZZVJP Member.H[PVU MVY[OL:[\K`VM[OL3P]LY,(:3 Treatment of chronic hepatitis C was in 2330 patients recruited in the US and recommends a 24-week treatment course ;OL0U[LYUH[PVUHS3P]LY*VUNYLZZ03* PU[LYUH[PVUHSH[[LU[PVUMYVT^P[OPUV\Y IL`VUK^OH[PZZ[HUKHYK[YLH[TLU[PU the mainstay,(:3»ZÅ atHNZOPWTLL[PUN the recent AASLDPZ Liver V^Germany.UJVTT\UP[ The combination`HZ^LSSHZ[O of LWsofosbuvirYLZZ >Lof sofosbuvirZ[LYU,\YVW plusLV ledipasvirY[OL<:H in Utreatment-KP[^PSSIL HMeetingWWYVHJOPUNMHZ[HUK^PSSVWLUVU(WYPS in Boston. Although most phase HUplusKT simeprevirLKPH^VYSK^PKL was extremely safe, as PUexperienced[LYLZ[PUN[VZL patientsLOV^[O with L`Lcirrhosis,U]PZHN L 3[O; dataO L.on V]theLYUPU IFN-freeN)VHYKV combinationsM,(:3^HZ of only 2% of patients discontinued due [YLalthoughH[TLU [VMJthis mightOYVUP beJO optimalLWH[P[PZ*P in termsU ]LsofosbuvirY`Z\JJLZZM\ plusSP ledipasvirUW\[[PUN[ andVNL[OL paritaprevirYH ;OtoLO sidePNOSPNO effects,[VM[O an LLespeciallyK\JH[PVUHS remarkable YLofZV\Y efficacyJLSPTP[ at theLKZL[ individual[PUNZ; patientOL> level,/6 OPNOWplus ombitasvirYVÄSLZJPLU[PÄJHUKLK\JH[PVUHS and dasabuvir were WYfeatVNYH if oneT[OP considersZ`LHY^ thatPSSIL[OL, 48% of(:3 patients N\PKLSPULat the populationZ^PSSILKPZJ\ZZLKK\YPUN[OL level this strategy might WYpresentedVNYHT^ inOPJO^PSSH April at EASL’s[[YHJ[HSV International[VM 7VhadZ[ NYHK\H[cirrhosisL* withV\YZL an episode^OPJO^PSSM of previousVJ\Z W\ISPJOLHS[OZLZZPVUHZ^limit access to treatment as drugLSSHZK pricing\YPUN Liver Congress, several compelling VdecompensationU[OL[YLH[TLU[VM] reportedPYHSOLWH[P[PZ in 40% of0U HZmayLWHY beH[ prohibitiveLZ`TWVZP\ for TKmostLKPJ healthcareH[LK[V[ OL 1HZVOHreal-lifeWWHU&RQWHQW data or clinical trials presentedV HKKP[PVU[them. 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The ^P[responseO1VPU[> (SVR)VYRZOVW ratesZI wereL[^L 89%LU, overall(:3 0HvsTZ 24 \Yweeks)L[OH[[O andLW ribavirinYVNYH TKneedL] inPZL 513KI` HUKHU\TILYVMPU[LYUH[PVUHSTLKPJHS [OL,(:3NV]LYUPUNIVHYK^PSSILHISL :KQO data can be divided into three broad with only a minimal impact of cirrhosis, cirrhotic patients, Bourlière and colleagues HZZVJPH[PVUZPU[OLÄLSKVMSP]LYKPZLHZL [VZH[PZM`[OLULLKZVMWYVMLZZPVUHS +XXY_XMOWOX^categories:$ >RO 3X^ Real-lifeO\XK^SYXKV 6S`O\ data of approved subtype 1a and previous treatment failure were able to suggest that the addition JV]LYPUNH^PKLZLSLJ[PVUVMPTWVY[HU[ OLWH[VSVNPZ[ZHZ^LSSHZWYV]PKLH -YXQ\O]] #regimens,^R + fine-tuningZ\SV 6YXNYX of approved to a protease inhibitor on the efficacy of ribavirin increased the efficacy of the LK\JH[PVUHS[VWPJZPU[OLLHYS`TVYUPUN Z[PT\SH[PUNSLHYUPUNH[TVZWOLYL[OH[^PSS Lc :\YPO]]Yregimens\ 7K\U_] :OM and RCTsU<K ofNY]K experimental`VTO`SM ^VratesYRZOVWZ in subgroup^P[OJ analysis.SPUPJHSZ`TWVZPHHZ THR12-weekL[OLH schedule[[LUKHUJ of LH[[Osofosbuvir/ledipasvirL03*H]LY` =OM\O^K\c 1drugs.OXO\KV / HCV+= Target6 provided the most ^LSSHZ[OLNYHUKYV\UKZ YLtoTHYRHISLL 96% overall,]L makingU[ it as effective as @SOXXK +interesting_]^\SK data in the first group In the fine-tuning group of studies, Marc the 24-week ribavirin-free arm (98% SVR). of studies as it reported safety and ;OBourlièreLZJPLU[PÄ fromJW Marseille,YVNYHTP FranceZZL[[VI stoleLL]L theU :VThis0J pieceVYKPHSS`P of informationU]P[L`V\[ hasVQ VPimportantU\ZPU :KQO efficacy of sofosbuvir and simemprevir TVYshowLL_J whenP[PUN[OPZ` reportingLHY a HsubgroupZPUKPJH[ analysisLK 3VUKVUPU(clinical implicationsWYPSH[[O as Lit highlights [O,(:3 that .OPO\\KV YP ^\OK^WOX^ SX 2-@ ZK^SOX^]$ <S]U] I`HYof phaseLJVY II-IIIKIYL trialsHRPU of NtreatmentH withIZ[YHJ[Z JVUNribavirinYLZ stillZH hasUK0O a placeVWL[OH[T in second-HU` Z\ITP[[LK[V[OL03*(TVUNZ[[OLZL PUNYLKPLU[Z^PSSJVU[YPI\[L[V^OH[^L KXN LOXOPS^] sofosbuvir + ledipasvir. This one pill-a-day generation interferon-free regimens, as it [OLTVZ[Hregimen receivedU[PJPWH[ FDALKVUL approvalZ^PSSIL[OVZL in the [OPUR^PSSILV\YSallows for shorter HYandNLZ cheaper[0U[LYUH treatment[PVUHS Lc :\YPONewsletter]]Y\ +VLO\ Contents^Y +VLO\^S WYlastLZLU month,[PUN[O andLK isH[HVMHS expectedHY NtoLU receive\TIL YVM 3Pschedules]LY*VUNYLZ withoutZ[VK compromisingH[L efficacy. :KNY`K 3^KVc Page 1 - 2 WOHZLEMA approval[YPHSZVMH shortly.SSVYHSKY\N[YLH[TLU[Z The FDA label A review of new data on the treatment of MVYJOYVUPJOLWH[P[PZ*)\[^OPSL[OLZL Continued on page 2 :KQO hepatitis C by Alessio Aghemo, M.D PhD [YPHSZ^PSSTHRLTVZ[VM[OLOLHKSPULZ ++Milan,=6. Italy$ 8Oa N\_Q] PY\ -R\YXSM [OL03*VќLYZT\JOTVYL[OHUQ\Z[[OL [YLH[TLU[VM]PYHSOLWH[P[PZ 7YVMLZZVY4HYR\Z7LJR9HKVZH]SQL]PJ 2OZK^S^S] , Hepatitis B and C Public Policy Association commissioned article is now available Page 2 - 3 :LJYL[HY`.LULYHS,(:3 The Gilead Sciences Research Scholar Lc .\ ASVVOW : ,\Y_aO\ KXN The5VUPU Hepatitis]HZP]LL]H B andS\H[PVUV C PublicMSP]LY Policy Association’s:[LSS]LY Working[YL[LUKL GroupY(I[LPS\UNZSLP report on[LY Program in Liver disease 2015 with :\YPO]]Y\ 2K\\c 6+ 4KX]]OX BarriersKPZLHZL Wto VYcare[HSO and`WLY treatment[LUZPVUHUKHSZV for patients with<UP] chronicLYZP[p[ZRS viralPUPRM hepatitis, Y0UULYL4 withLK GeorgePaPU000 Prof Michael P. Manns -KXKNK KXN ^RO 8O^RO\VKXN] Papatheodoridis[YLH[TLU[VMWYPTHY and`I HeinerPSPHY`J PYYOVZPZ^PSSWedemeyer as 2SPUPZJOprincipalL( investigators, wasI[LPS\UNM\Y.HZ[YVLU[ publishedLYVSVNPL Page 3 asYLWY a LZLUsystematic[V[OLYO reviewPNOSPNO[ articleZVM[O inL0 Liver3* International\UK/LWH[ earlierVSVNPL this year. ‘Barriers to care and treatment for patients with chronic viral hepatitis in Europe: a systematic review’ How a reduced price for Sofosbuvir was Q\Z[[VTLU[PVUHML^-YVTHW\ISPJ >pOYPUNLY. Y[LS :KQO Liver International ISSN 1478-3223. The report is freely accessible on obtained for Egypt by Prof Gamal Esmat, WVSPJ`WVPU[VM]PL^[OLOV[[VWPJ^PSS ( >PLU /\KNSMK^SYX YP 2OZK^S^S] - `S\_] 2-@$ http://onlinelibrary.wiley.com/doi/10.1111/liv.12565/pdf. Cairo, Egypt IL[OLSH\UJOVM[OL>/6N\PKLSPULZ :Y]]SLSVS^c Y\ PKX^K]c ,THPS!THYR\ZWLJR'TLK\UP^PLUHJH[ Page 4 - 5 TVheU[O reportL[YLH[T wasLU commissioned[VMJOYVUPJOLW byH[P[ thePZ Hepatitis B and C PPA, with non-financial Lc :\YPO]]Y\ 4Y\NKX 4 0OVN Chronic hepatitis E virus infection by support*K\YPUN[O fromL03 EASL*PU3 andVUKVU ELPA.9LJLU[S` -\Y[OLYPUMVYTH[PVUYLNHYKPUN03* >YProfs\YX^Y -V. KXKNKMallat and S. Pol, Paris, France >/6OHZJVTWPSLKN\PKLSPULZVU[OL JHUILMV\UKH[[OL,(:3^LIZP[L! THUHNLTLU[VMOLWH[P[PZ*^OPJONV ^^^LHZSL\ 1 (QTXLULHVWREnquiries+HSDWLWLV% & to: Hepatitis3XEOLF3ROLF B & C Public Policy\$V AssociationVRFLDWLRQDVEO_ asbl | email:HPDL [email protected]ǸFH#KHSEFSSD RUJ www.hepbcppa.org ZZZKHSEFSSDRUJ DECEMBER 2014 ISSUE Several new compounds were presented genotype 1 patients with advanced companies, which should translate into at the Liver Meeting including the fibrosis or with a previous treatment a rapid decrease in costs of drugs for second-generation NS5A inhibitor failure with pegylated interferon-based healthcare systems. A key factor if broad GS-5816 which managed to achieve regimens. Both interferon-free regimens and equal access to these drugs across high SVR rates in combination with were extremely safe with less than Europe is to be achieved. sofosbuvir. Still the most compelling data 3% of patients discontinuing due to came from the Phase III studies of the side effects and without any significant Alessio Aghemo, M.D. PhD. combination of grazoprevir (protease safety signal in these two large Phase III Division of Gastroenterology and inhibitor) plus elbasvir (NS5A inhibitor) studies. These efficacy and safety rates Hepatology, Fondazione IRCCS Ca’ and the combination of daclatasvir are not surprising nowadays. Given the Granda Ospedale Maggiore Policlinico (NS5A) plus asunaprevir (protesase fact that in the past limited access to di Milano and Università degli Studi di inhibitor) and beclabuvir (NS5b Non- treatment hampered the effectiveness Milano, Italy nucleoside inhibitor). These 2 different of anti-hepatitis C therapy hence, any Email: [email protected] interferon strategies managed to reach new player in the therapeutic field should 90-100% and 93-98% SVR rates, be viewed positively as this will likely respectively in difficult-to-cure HCV lead to competition between pharma The Gilead Sciences Research Scholars Program: An interview with Professor Michael Manns, Chairman of the The Gilead Sciences Research Scholars Committee. Q1. Could you kindly explain the Gilead Sciences The applicant should also be able to obtain/secure a faculty Research Scholars Program for our readership? position within the next 3 years and should devote his academic career to research in liver diseases. The Gilead Sciences Research Scholars Program is a very attractive program for junior researchers to obtain funding to the Q2: As the Chairman of the Committee, what are the value of US$ 130,000, which is paid in two annual installments features you are looking for when evaluating a research of up to US$ 65,000 each. The Gilead Sciences Research project proposal? Scholars Program is active in various fields of medicine including cardiovascular disease, primary pulmonary hypertension, cystic The package of the research proposal consists of the applicant, fibrosis, haematology and oncology as well as liver diseases. the mentor, the institution, and the project. We evaluate The Liver Disease Research Scholars Program has a North the applicant concerning his past and present research American as well as an International Program.