Peginterferon Alfa-2a/Ribavirin for 48 or 72 Weeks in Hepatitis C Genotypes 1 and 4 Patients With Slow Virologic Response

Ferenci, Péter; Laferl, Hermann; Scherzer, Thomas–Matthias; Maieron, A; Hofer, Harald; Stauber, Rudolf; Gschwantler, Michael; Brünner, H.; Wenisch, Christoph; Bischof, Martin; Straßer, Michael; Datz, Christian; Vogel, Wolfgang; Löschenberger, Karin; Steindl–Munda, Petra

doi:10.1053/j.gastro.2009.10.058

Cited by 114 publications

(116 citation statements)

References 17 publications

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“…However, both the per-protocol and completers analyses of this large population also revealed similar SVR rates, confirming that relapse rates do not change significantly when treatment duration is increased from 48 weeks to 72 weeks and, therefore, overall rates of SVR also remain similar. It is noteworthy that the relapse rate of 32.7% observed in the 72-week treatment arm is comparable to the relapse rate of 31.0% reported by Ferenci et al 10 in the subgroup of patients with partial early virologic response at week 12 and undetectable HCV RNA at week 24 who were treated for 72 weeks.…”

Section: Discussionsupporting

confidence: 78%

“…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.…”

Section: Discussionmentioning

confidence: 99%

“…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.…”

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confidence: 99%

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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

Buti

Lurie

Zakharova³

et al. 2010

Hepatology

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The benefit of extending treatment duration with peginterferon (PEG-IFN) and ribavirin (RBV) from 48 weeks to 72 weeks for patients with chronic hepatitis C genotype 1 infection has not been well established. In this prospective, international, open-label, randomized, multicenter study, 1,428 treatment-naïve patients from 133 centers were treated with PEG-IFN alfa-2b (1.5 lg/kg/week) plus RBV (800-1,400 mg/day). Patients with detectable hepatitis C virus (HCV) RNA and a !2-log 10 drop in HCV RNA levels at week 12 (slow responders) were randomized 1:1 to receive 48 weeks (n 5 86) or 72 weeks (n 5 73) of treatment. Sustained virologic response (SVR) rates were 43% in slow responders treated for 48 weeks and 48% in slow responders treated for 72 weeks (P 5 0.644). Relapse rates were similar in slow responders treated for 48 or 72 weeks (47% versus 33%, P 5 0.169). The safety profile was similar in both treatment arms; serious adverse events leading to discontinuation of treatment were observed in 3.5% of slow responders treated for 48 weeks and 8.2% of those treated for 72 weeks. Among slow responders with a <2-log drop in HCV RNA at week 8, SVR was 39% in the 72-week arm and 19% in the 48-week arm. Conclusion: These data suggest that 48 weeks of therapy with PEG-IFN alfa-2b plus RBV (800-1,400 mg/day) should remain a standard-of-care treatment for treatment-naïve G1 slow responders. (HEPATOLOGY 2010;52:1201-1207

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Section: Discussionsupporting

confidence: 78%

Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

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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

Buti

Lurie

Zakharova³

et al. 2010

Hepatology

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“…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).…”

Section: Uvodunclassified

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

Bozic

Bojović

Đonić-Nenezić

et al. 2011

BII

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1Klinika za infektivne i tropske bolesti Kliničkog centra Srbije, Beograd Uvod. Hepatitis C virus (HCV) je jedan od glavnih uzročnika hroničnog hepatitisa, ciroze jetre i hepatocelularnog karcinoma (HCC). Savremena terapija hroničnog hepatitisa C (HHC) podrazumeva primenu pegilovanog interferona alfa 2a ili 2b (PEG IFN-α2a ili PEG IFN-α2b) i ribavirina (RBV). Cilj rada je da se proceni efikasnost HCV terapije i faktora za predviđanje terapijskog odgovora. Rezultati. U grupi bolesnika sa HHC više je bilo muškaraca (59,3%), starijih od 40 godina (58,2%), sa visokim stepenom bazalne viremije (63%) i sa G1 (67%) HCV. Bridging fibroza i ciroza (F3, F4) su nađene kod 54 (27, 84%) bolesnika. Stabilan virusološki odgovor (SVR) je postignut kod 69,2%, relaps kod 11,9%, a bez odgovora na terapiju je bilo 19,8% bolesnika. Faktori koji su uticali na postizanje SVR bili su: non-1 genotip HCV (OR 5,9; 95% IP: 1,9-18,0), EVR (OR 0,92,; 95% IP: 2,73-35,97) i bolesnici mlađi od 40 godina (OR 3,66; 95% IP: 1,48-9,0). Neuspeh terapije u vidu relapsa zavisio je od visine bazalne viremije (OR 0,37; 95% IP: 0,12-0,97), godina života >40 godina (OR 4,8; 95% IP: 1,35-17,84) i prisustva ciroze (OR 2,1; 95% IP: 1,0-4,7). Kod bolesnika bez odgovora na terapiju faktori predviđanja neuspeha su bili: G1 (OR 3,9; 95% IP: 1,5-10,3), visoka bazalna viremija (OR 3,45; 95% IP: 1,19) i prekid u kontinuitetu primene terapije (OR 4,49; 95% IP: 1,76).Zaključak. Savremena, standardna terapija je bila efikasna kod 127/194 (69,2%) bolesnika sa HCC. Najznačajniji faktori za predviđanje uspeha terapije bili su: genotip HCV, EVR kod G1, životno doba bolesnika, stepen bazalne viremije, prisustvo ciroze i prekid u kontinuitetu terapije.Ključne reči: hronični hepatitis C, efikasnost antivirusne terapije, predviđanje virusološkog odgovora.

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“…A number of studies suggested that immune response has a crucial role in pathogenesis and outcome of hepatitis C virus infection [6,22,33,39,40]. A combined treatment including Peginterferon Alfa-2a/Ribavirin with or without protease inhibitor has become the standard course for the treatment of CHCV infection [10]. The efficacy of treatment depends on several factors such as baseline viral load, severity of liver disease, body weight, ethnicity and viral genotype with type 1 appearing to be less responsive to treatment than other types [44].…”

Section: Introductionmentioning

confidence: 99%

Peginterferon Alfa-2a/Ribavirin treatment efficacy in chronic hepatitis C patients is related to natural killer group 2D gene rs1049174 GC polymorphism

et al. 2016

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Natural killer group 2D (NKG2D), as an activating receptor, plays pivotal role in viral infectious diseases. Several single nucleotide polymorphisms (SNPs) in the NKG2D gene have characterized that the rs1049174G/ C SNP of NKG2D is in the spotlight of notice because of its role in activating of human T cells. This study aimed to investigate rs1049174G/C genetic polymorphism in Chronic Hepatitis C (CHC) patients. The study compromised 107 CHC patients with genotype 1a and 1b. All recruited patients were under treatment with Peginterferon Alfa-2a/Ribavirin according to standard protocol. After completing treatment, 67 patients showed sustained virologic response (SVR) and the rest of patients did not respond to the treatment and considered as non-responder (NR). Genotyping of NKG2D rs1049174G/C SNP was performed using PCR-RFLP method in SVR and NR patients. The NKG2D rs1049174 genotypes frequency for GG, GC and CC were 45, 41 and 14 % respectively. Genotypes distribution were significantly different between SVR and NR groups (p = 0.005). So that the patients with the homozygous GG genotype demonstrated a higher response to Peginterferon Alfa-2a/Ribavirin therapy against HCV infection (OR = 6.0, 95 %CI 1.71-21.08, p = 0.005). In conclusion, the rs1049174 GG genotype of NKG2D receptor is an effective factor in successfully treatment of CHC patients by Peginterferon Alfa-2a/ Ribavirin.

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Peginterferon Alfa-2a/Ribavirin for 48 or 72 Weeks in Hepatitis C Genotypes 1 and 4 Patients With Slow Virologic Response

Cited by 114 publications

References 17 publications

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

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

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

Peginterferon Alfa-2a/Ribavirin treatment efficacy in chronic hepatitis C patients is related to natural killer group 2D gene rs1049174 GC polymorphism

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