Peginterferon-Alfa2a Plus Ribavirin for 48 Versus 72 Weeks in Patients With Detectable Hepatitis C Virus RNA at Week 4 of Treatment

Randomized trial of peginterferon alfa-2b and ribavirin for 48 or 72 weeks in patients with hepatitis C virus genotype 1 and slow virologic response

“…However, in these studies (one prospective study in patients with detectable HCV RNA at week 4, and one retrospective analysis of patients with HCV RNA !50 IU/mL at week 12 and <50 IU/mL at week 24), 6,7 patients were treated with a fixed dose of RBV (800 mg), resulting in SVR rates of 17% and 28% in the 48-week treatment arms. Essentially, these studies showed that extending treatment duration to 72 weeks was associated with lower relapse in patients treated with a suboptimal dose of RBV.…”

“…In one study, a fixed dose of RBV (800 mg/day) was used, resulting in a low SVR rate of 28% in patients treated for 48 weeks. 7 In the second study, RBV dosing was adjusted according to body weight, resulting in SVR rates of 51% and 60% with 48 and 72 weeks of therapy, respectively. 10 The patients selected for extended treatment duration in these two studies were a heterogeneous population who achieved a virologic response at various time points after week 4 and, because some of these patients would have achieved undetectable HCV RNA between weeks 4 and 12 of treatment, they cannot be regarded as true slow responders.…”

“…4,5 Several studies adopting this approach have shown that extending therapy to 72 weeks may increase SVR rates in selected G1 patients. [6][7][8][9][10][11] However, the on-treatment virologic criteria used to select patients for extended therapy vary across studies. Accurately defining which G1 patients will benefit from extended treatment is important, because prolonged treatment is associated with increased adverse events and higher costs.…”

Savremena terapija hroničnog hepatitisa C: efikasnost i mogućnost predviđanja terapijskog odgovora

“…Zato se aktuelne preporuke za praćenje virusološkog odgovora na terapiju baziraju na postizanju rapidnog virusološkog odgovora (rapid virological response, RVR), kompletnog ranog virusološkog odgovora (complete early virological response, cEVR) i parcijalnog ranog virusološkog odgovora (partial early virological response, pEVR) [3,15,[20][21][22]. Rapidan virusološki odgovor ili kompletan rani virusološki odgovor su korisni u predviđanju uspeha terapije ili postizanju SVR.…”

“…Bolesnici sa G1 i RVR mogu se kraće lečiti -24 umesto 48 nedelja [20,21]. Kod bolesnika sa G1 i pEVR koji su teški za lečenje SVR raste sa produžavanjem terapije (od 48 na 72 nedelje) od 52% na 69% [22][23][24][25]. Zato su preporuke za poboljšanje anti-HCV terapije za G1 bazirane na RVR i nivou bazalne viremije (količini HCV RNK u serumu pre početka terapije) (Tabela 5).…”