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Marted=EC 8 Novembre 2005 22:18			=20

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Epatite C, vaccino made = in Italy=20

Iniziata negli Usa la = sperimentazione sull=92uomo del vaccino preparato a Siena. = Intervista=20 al dott. Sergio Abrignani

Sono almeno 200 milioni nel = mondo i=20 portatori pi=F9 o meno =93sani=94 del virus dell=92epatite = C. Un numero=20 largamente superiore ai contagiati da virus HIV, = responsabile=20 dell=92Aids. Ma i malati di epatite cronica di tipo=20 C, la stragrande maggioranza (9 su 10), sono=20 asintomatici cio=E8 non presentano sintomi = della=20 malattia, anche per 10-15 anni, pur costituendo una notevole = causa=20 d=92infezione per le altre persone sane. In Italia si = calcola che=20 circa l=921-2 per cento della popolazione sia stata = infettata dal=20 virus dell=92Epatite C (HCV)responsabile della malattia = divenendone=20 portatore sano. Oggi l=92epatite cronica di tipo C si pu=F2 = curare con=20 efficacia, grazie alle nuove terapie, mentre la ricerca sta = facendo=20 progressi incoraggianti: si confida molto in un = nuovo=20 vaccino made in Italy, sperimentato da un=92equipe = di=20 ricercatori della Chiron Vaccines di Siena.
Il gruppo di = scienziati =E8 coordinato dal dottor Sergio=20 Abrignani, lo stesso che nel novembre 1998 aveva = scoperto=20 la molecola CD81, cio=E8 il punto utilizzato dal virus HCV = per entrare=20 nelle cellule epatiche umane.

Qual =E8 il = meccanismo=20 d=92azione del vostro vaccino?
=93Pi=F9 di tre = anni fa=20 abbiamo individuato =96 spiega il dottor Sergio Abrignani - = la porta=20 d=92ingresso del virus dell=92epatite C nelle cellule del = fegato. Il=20 nuovo vaccino agisce stimolando la produzione di anticorpi e = linfociti. I primi impediscono l=92ingresso del virus = nell=92epatocita=20 riducendo la carica infettante e limitando di gran lunga il = numero=20 di cellule che vengono attaccate dall=92HCV; i linfociti T = eliminano=20 le poche cellule che il virus riesce ad infettare. In altre = parole,=20 il vaccino induce sia una risposta anticorpale che = una=20 risposta linfocitaria T. Dai nostri studi, sappiamo = pure=20 che nessuna di queste due risposte specifiche da sola =E8 = sufficiente=20 per contrastare l=92infezione: occorrono entrambe. A livello = molecolare, il vaccino induce la produzione di anticorpi che = interferiscono sul legame del virus HCV con la molecola = CD81.=20 Quest=92ultima =E8 una sorta di scaletta d=92ingresso che = viene fatta=20 saltare nel meccanismo dell=92infezione, rendendo cos=EC = molto pi=F9=20 difficile la vita al virus=94.

E=92 una = ricerca tutta=20 italiana?
=93Certamente. Gi=E0 nel 1989 =96 = conferma=20 Abrignani - il nostro gruppo aveva scoperto, insieme ad = altri,=20 l=92esistenza dell=92HCV, il terzo dei virus epatitici, = quello pi=F9=20 diffuso. Dal 1990 =E8 disponibile un test per rilevare gli = anticorpi=20 prodotti dal nostro sistema immunitario contro di esso: sono = gli=20 anticorpi anti-HCV. Il virus non =E8 mai = stato visto=20 al microscopio o isolato in laboratorio, ma si sa che esiste = perch=E9=20 noi scienziati ne abbiamo evidenziato l=92RNA, il codice = genetico=20 della molecola, mediante sofisticati strumenti. Abbiamo = scoperto di=20 aver a che fare con un virus parecchio=20 trasformista: ogni genotipo (la classe genetica, = ndr) di=20 HCV =E8 caratterizzato da una diversa aggressivit=E0 o = capacit=E0 di=20 replicarsi. Fra classi e sottoclassi, i genotipi = sono 10 con=20 un centinaio di sottotipi: quelli prevalenti nella=20 popolazione mondiale sono i genotipi 1 e 2=94. =

Come si=20 =E8 svolta la sperimentazione sul vaccino
=93La = prima fase=20 di sperimentazione sugli animali =E8 stata esaurita=94, = chiarisce il=20 dottor Abrignani. =93Tutti gli esperimenti sono stati fatti = finora con=20 virus eterologhi, cio=E8 diversi da quello = utilizzato=20 per il vaccino, ma di genotipo 1. Ora stiamo provando a = vedere,=20 sugli scimpanz=E9, che cosa succede con genotipi diversi. = Avremo i=20 risultati definitivi fra un anno circa. Questi esperimenti = hanno=20 finora dimostrato che si pu=F2 proteggere l=92animale = dall=92infezione=20 cronica: gli scimpanz=E9 vaccinati si infettano ma non = contraggono la=20 malattia perch=E9 l=92infezione viene risolta entro sei mesi = dalla=20 vaccinazione: quindi il vaccino =E8 certamente terapeutico = per questa=20 specie animale. E=92 una sostanza efficace per prevenire = l=92infezione=20 cronica, che cos=EC =E8 risolta nel 90% dei casi=94. =

E=92=20 gi=E0 partita la sperimentazione del vaccino = sull=92uomo
Il=20 dottor Abrignani non nasconde la sua emozione nel dare = l=92annuncio:=20 =93E=92 questa la novit=E0 assoluta. E=92 in corso, = dal novembre=20 scorso negli Stati Uniti, la sperimentazione del nostro = vaccino anti=20 epatite C, sull=92uomo. Stiamo facendo la = sperimentazione=20 oltre Oceano per motivi tecnici e burocratici. Siamo in = piena=20 fase 1, che durer=E0 un anno: a 60 persone = sane =E8=20 stato somministrato il =93candidato vaccino=94 a scopo = preventivo; altri=20 40 volontari, gi=E0 infettati dal virus, si sono sottoposti = alla cura=20 vera e propria con l=92altra variante del vaccino. Le prove = cliniche=20 sui malati dovranno dimostrare l=92efficacia terapeutica del = nuovo=20 farmaco. E sarebbe una grande conquista per tutto il mondo=20 scientifico. Finora, infatti, non esistono al mondo vaccini=20 terapeutici contro nessuna malattia. Nel nostro caso, stiamo = cercando di sapere se il nostro preparato =96 dato a persone = con=20 infezione da epatite C in corso da anni =96 riesce a = modificare in=20 meglio l=92andamento dell=92infezione. Ma il nostro studio = =E8 appena agli=20 inizi. Non abbiamo a disposizione dati significativi e = perci=F2 andrei=20 molto cauto=94.

Che tempi occorrono per = sapere se il=20 vaccino funziona anche sugli uomini?
=93Abbiamo = la=20 certezza =96 spiega ancora Abrignani - che il nostro = =93candidato=20 vaccino=94 non =E8 nocivo e induce risposte = immunitarie=20 nelle persone a cui =E8 stato somministrato.
E=92 chiaro = che stiamo=20 parlando di esperimenti molto lunghi perch=E9, per avere = risultati=20 sulla protezione effettiva dall=92infezione cronica da HCV, = bisogna=20 attendere almeno un anno. Tuttavia, abbiamo verificato sui = volontari=20 sani che il vaccino a scopo preventivo =E8=20 sicurissimo, non nocivo e induce ottime risposte = immunitarie. Poi=20 dovr=E0 seguire una fase 2, per un altro = anno, su un=20 gruppo di 200 pazienti. La fase 3 si estender=E0 ad alcune = migliaia di=20 persone. La sperimentazione sull=92efficacia del nuovo = vaccino=20 dovrebbe concludersi in 5 anni, entro il 2006 o il 2007. = Devo=20 precisare che stiamo portando avanti la fase 1 nell=92uomo = su quei=20 soggetti gi=E0 infettati che non hanno risposto alla cura = con=20 Interferone. I primi dati arriveranno fra un anno o un anno = e mezzo.=20 In questa fase ci siamo posti due obiettivi: verificare la = sicurezza=20 del preparato; non peggiorare le condizioni generali del = paziente=94.=20

Ma funzioner=E0 sempre, con tutti i genotipi = di HCV,=20 il vaccino che state sperimentando?
=93E=92 = proprio questo=20 il punto che ci fa essere ottimisti. Sappiamo che non vi = sono=20 differenze fra i due genotipi maggiori dell=92HCV, = l=921a e=20 l=921b. Nel mondo occidentale, circa il 50% della = popolazione=20 =E8 infettato proprio da questi due particolari genotipi e = il vaccino=20 sperimentale =E8 risultato efficace in entrambi i casi. = Questo =E8 un=20 dato importante perch=E9 la risposta all=92Interferone e = alla Ribavirina=20 (la terapia d=92elezione per l=92epatite C) =E8 = efficacissima nell=9280-90%=20 dei casi se la persona =E8 stata infettata da HCV di = genotipi 2 e 3; =E8=20 meno efficace, abbassandosi al 40-50%, se l=92infezione = avviene ad=20 opera dei genotipi 1a e 1b. Quindi, l=92aver dimostrato che = il vaccino=20 funziona proprio in questi ultimi casi, ci fa ben sperare = anche per=20 le cure future sull=92uomo=94.

Le vie di = contagio del=20 virus HCV: la malattia si scopre =93casualmente=94=20
L=92epatite di tipo C =E8 una malattia subdola, che si = manifesta=20 soprattutto quando diventa cronica. Si scopre =93per = caso=94, magari con=20 un controllo di routine sul sangue.
Il contagio avviene=20 attraverso il contatto con il sangue o le = sue=20 componenti specifiche infette (emoderivati): plasma, globuli = rossi,=20 bianchi o piastrine. La diffusione di questa malattia =E8 = maggiore=20 rispetto all=92Aids perch=E9 il virus HCV =E8 pi=F9 = resistente alla=20 temperature esterne, fuori dall=92organismo umano. Cos=EC il = contagio=20 fra persone infette e sane =E8 molto pi=F9 probabile. Oggi = per=F2 il=20 gruppo a maggior rischio di contagio =E8 quello dei=20 tossicodipendenti, attraverso il passaggio = di=20 siringhe infette usate da un =93portatore della malattia=94 = ad uno sano.=20 Al secondo posto, ma con minime possibilit=E0, c=92=E8 il = contagio durante=20 i rapporti sessuali. Pi=F9 probabile, anche = questo,=20 se uno dei partner =E8 tossicodipendente gi=E0 contagiato = dal virus. E=92=20 da sottolineare un aspetto molto discusso: le = trasfusioni di=20 sangue oggi sono assolutamente sicure. Prima del = 1990 molte=20 persone sono state infettate in seguito alle trasfusioni = perch=E9 il=20 virus HCV era ancora poco noto. Da allora il virus viene = testato in=20 maniera certa ed efficace in tutti gli emoderivati.=20

Cosa deve fare un malato di epatite C=20 cronica
Risponde il dottor Maurizio=20 Tommasini, responsabile dell=92Unit=E0 operativa di = Medicina=20 Generale ed Epatologia di Humanitas: =93La prima cosa da = fare =E8=20 seguire una dieta e moderare il consumo di alcolici e = superalcolici.=20 E=92 assolutamente proibito fare uso di farmaci senza = controllo=20 medico. Dobbiamo ricordare, infatti, che tutte le = medicine=20 vengono eliminate attraverso il fegato. Basti = pensare che=20 in una persona normale molti farmaci si rivelano tossici, in = una con=20 il fegato malato lo sono ancora di pi=F9. I pi=F9 a rischio? = Sono gli=20 antinfiammatori in generale e tutti gli antibiotici per la = cura=20 della tubercolosi=94.

Alcuni consigli per = evitare il=20 contagio da HCV
=93Attenzione=94 avverte il = dottor=20 Tommasini, =93infettarsi con il virus =E8 molto difficile. = Ci=F2=20 costituisce un paradosso, in considerazione dell=92alto = numero di=20 persone contagiate. Devono perci=F2 sussistere due fattori: = una=20 concentrazione di virus infettante molto alta in relazione = ai bassi=20 livelli circolanti nel sangue e alla sua labilit=E0; la = persona=20 attaccata deve essere immunologicamente debole. Se vengono=20 soddisfatte queste condizioni, pu=F2 essere a rischio = d=92infezione=20 chiunque venga a contatto con sangue infettato dal virus =96 = spiega il=20 dottor Tommasini - attraverso aghi = da=20 siringa, ma anche con la pratica dei=20 tatuaggi o del piercing.=20 Controllate perci=F2 che la persona che esegue questi = interventi di=20 =93piccola chirurgia=94 sia titolata a farli e abbia = sterilizzato lo=20 strumentario o, meglio, esegua il suo lavoro con materiali = monouso.=20 Inoltre, se si vive a stretto contatto con un portatore di = epatite C=20 =E8 meglio: usare il preservativo durante i = rapporti=20 sessuali occasionali o con persone a rischio; = evitare lo=20 scambio di siringhe tra tossicodipendenti; = utilizzare=20 esclusivamente oggetti monouso =96 ad = esempio le=20 siringhe - o personali, come lo spazzolino da denti, = pettini, rasoi,=20 forbici. E infine: disinfettate sempre gli oggetti che = possono=20 essere contaminati dal virus=94.

Le cure = mediche oggi=20 a disposizione: Interferone e Ribavirina=20
=93L=92epatite C cronica oggi si cura = con=20 l=92Interferone associato alla Ribavirina per bocca: = l=92efficacia =E8 del=20 40-50%=94, spiega il professor Antonio = Gasbarrini,=20 associato di Medicina Interna all=92Universit=E0 = Cattolica-Policlinico=20 Gemelli di Roma. =93Esiste da poco tempo un nuovo farmaco = che ci sta=20 dando grandi soddisfazioni: =E8 l=92Interferone peghilato, = cos=EC chiamato=20 perch=E9 =E8 legato ad altre sostanze che ne favoriscono = l=92assorbimento.=20 Questo nuovo tipo di Interferone si somministra con = un=92infusione=20 sottocutanea ogni settimana sfruttando il fatto che il = farmaco=20 rimane a lungo nel sangue. Ogni ciclo di Interferone = dura=20 dai 6 mesi ad un anno, se =E8 necessario. Questa = nuova cura=20 non prevede la somministrazione a giorni alterni, per tre = volte alla=20 settimana, come il vecchio Interferone alfa, che presentava = problemi=20 di tolleranza e tossicit=E0 per i malati: non si potevano = usare dosi=20 elevate, abbassava il numero dei globuli rossi e bianchi, = dava=20 effetti collaterali simili all=92influenza.
Inoltre = l=92associazione=20 Interferone Peghilato-Ribavirina si =E8 rivelata efficace = nel 60-70%=20 dei casi, perch=E9 induce la formazione di anticorpi che = eliminano il=20 virus HCV=94

E per quei malati di epatite C = cronica=20 che non dovessero rispondere a questa terapia? =
=93Se la=20 cura si dovesse rivelare poco o per nulla efficace =96 = precisa il=20 professor Gasbarrini - si pu=F2 passare ad un secondo ciclo = degli=20 stessi farmaci associati ma a dosi pi=F9 = alte:=20 modificando la posologia, si estender=E0 l=92efficacia ad = un=20 altro 20-30% di persone. E per chi non risponde a = nessun=20 tipo di terapia, si somministreranno pi=F9 cicli di = Interferone. In=20 genere, la cura si inizia in ospedale e si prosegue a casa. = Nella=20 fase iniziale la terapia pu=F2 dare effetti collaterali = simili ai=20 sintomi dell=92influenza, ma in generale =E8 efficace e ben = tollerata=94.=20

A cura di Umberto Gambino=20

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Humanitas Salute = Direttore=20 responsabile: Mario Galli Coordinamento redazione: Walter = Bruno Via=20 Manzoni 56, 20089 Rozzano (MI) Tel. 02 8224 2405 Fax 02 8224 2413 = \|\| INFO: redazione A= utorizzazione=20 del Tribunale di Milano n=B0 296 del 21 maggio 2001 \| Copyright = =A9=20 Humanitas Mirasole 2001. Tutti i=20 diritti riservati

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