Allegato 1a -  Interferoni e farmaci correlati per il
trattamento dell’infezione cronica da HCV e HBV.  
Il contesto regionale abruzzese appare caratterizzato da una
significativa prevalenza di infezione cronica a scarso epatotropismo
e transaminasi persistentemente normali. In merito a tale classe farmacologica,
pertanto, la principale raccomandazione di carattere locale è che gli
interferoni, peghilati e non, con autorizzazione alla
rimborsabilità in soggetti con transaminasi normali, non siano impiegati se non
a fronte di una adeguata documentazione di sussistente
danno epatico, acquisita mediante esecuzione di esame Fibroscan
e/o di biopsia epatica (1-10). In altri termini, data l’alta prevalenza di
infezione cronica da virus epatite C a transaminasi persistentemente normali
nella nostra area, e dato il costo elevato degli interferoni, sembra opportuno
limitarne l’impiego ai casi in cui il danno epatico, anche moderato, sia
effettivamente documentato (11-13). Per quanto riguarda il virus epatite B,
alla luce delle recenti evidenze di letteratura a riguardo di una maggiore
incidenza di carcinoma epatico nei soggetti con elevata e persistente replica
virale, potrebbe essere considerato l’uso dell’interferone peghilato
anche in assenza di una chiara documentazione di danno epatico a fronte di
modesto movimento delle transaminasi, se la replica virale fosse
persistentemente >106 UI/mL (14-16).
Resta l’evidenza consolidata di letteratura, comunque, a supporto di una
migliore risposta virologica nei soggetti con ipetransaminasemia
sostenuta.
 
 
Referenze
 - Marcellin P, Levy S, Erlinger S. Therapy of hepatitis C: patients
     with normal aminotransferase levels. National
     Institutes of Health Consensus Development Conference Panel Statement:
     Management of Hepatitis C. Hepatology 1997;
     26:33S–6S.
 
 - Tassopoulos NC. Treatment in patients with
     normal ALT levels. EASL International Consensus Conference on Hepatitis C:
     Consensus Statement. J Hepatol 1999; 30:956–61.
 
 - Bacon
     BR. Treatment of patients with hepatitis C and normal serum aminotransferase levels. Hepatology.
     2002; 36:S179-84.
 
 - Almasio PL, Cottone C, D'Angelo F. Pegylated
     interferon therapy in chronic hepatitis C: lights and shadows of an
     innovative treatment. Dig Liver Dis. 2007; 39:S88-95.
 
 - Dalgard O, Bjøro K,
     Ring-Larsen H, Bjornsson E, Holberg-Petersen
     M, Skovlund E, Reichard
     O, Myrvang B, Sundelöf
     B, Ritland S, Hellum
     K, Frydén A, Florholmen
     J, Verbaan H; North-C Group. Pegylated
     interferon alfa and ribavirin
     for 14 versus 24 weeks in patients with hepatitis C virus genotype 2 or 3
     and rapid virological response. Hepatology. 2008; 47:35-42.
 
 - Kamal SM, El Kamary
     SS, Shardell MD, Hashem
     M, Ahmed IN, Muhammadi M, Sayed
     K, Moustafa A, Hakem
     SA, Ibrahiem A, Moniem
     M, Mansour H, Abdelaziz
     M. Pegylated interferon alpha-2b plus ribavirin in patients with genotype 4 chronic
     hepatitis C: The role of rapid and early virologic
     response. Hepatology. 2007; 46:1732-40.
 
 - Yu JW, Wang GQ, Sun LJ, Li XG, Li SC. Predictive value of rapid virological response and early virological
     response on sustained virological response in
     HCV patients treated with pegylated interferon
     alpha-2a and ribavirin. J Gastroenterol
     Hepatol. 2007; 22:832-6.
 
 - Simin M, Brok J, Stimac D, Gluud C, Gluud LL. Cochrane systematic review: pegylated interferon plus ribavirin
     vs. interferon plus ribavirin for chronic
     hepatitis C. Aliment Pharmacol Ther. 2007; 25:1153-62.
 
 - Poynard T. Treatment of cirrhotic patients in the
     pegylated interferon era. Dig Liver Dis. 2004;
     36:S344-8.
 
 - Heathcote J, Zeuzem S. Pegylated interferon monotherapy
     for chronic hepatitis C. Semin Liver Dis. 2004;
     24:39-45. 
 
 - Gerkens S, Nechelput M,
     Annemans L, Peraux B, Beguin C, Horsmans Y. A
     health economic model to assess the cost-effectiveness of pegylated interferon alpha-2a and ribavirin
     in patients with moderate chronic hepatitis C and persistently normal alanine aminotransferase
     levels. Acta Gastroenterol
     Belg. 2007; 70:177-87.
 
 - Shepherd J, Brodin HF, Cave CB, Waugh NR,
     Price A, Gabbay J. Clinical- and
     cost-effectiveness of pegylated interferon alfa in the treatment of chronic hepatitis C: a
     systematic review and economic evaluation. Int J
     Technol Assess Health Care. 2005; 21:47-54.
 
 - Shepherd J, Jones J, Hartwell D, Davidson P, Price A, Waugh N.
     Interferon alpha (pegylated and non-pegylated) and ribavirin for
     the treatment of mild chronic hepatitis C: a systematic review and
     economic evaluation. Health Technol Assess.
     2007; 11:1-205.
 
 - Marcellin P, Lada O, Asselah T. Treatment of
     chronic hepatitis B with the combination of pegylated
     interferon with lamivudine. Hepatol
     Res. 2007; 37:S55-61.
 
 - Morgan
     M, Keeffe EB. Diagnosis and treatment of chronic
     hepatitis B: 2009 update. Minerva Gastroenterol Dietol. 2009; 55:5-22.
 
 - Kaymakoglu S, Oguz D, Gur G, Gurel S, Tankurt E, Ersöz G, Ozenirler S, Kalayci C, Poturoglu S, Cakaloglu Y, Okten A. Pegylated
     interferon Alfa-2b monotherapy and pegylated interferon Alfa-2b plus lamivudine
     combination therapy for patients with hepatitis B virus E antigen-negative
     chronic hepatitis B. Antimicrob Agents Chemother. 2007; 51:3020-2.