Predicting sustained virological responses in chronic hepatitis C patients treated with peginterferon alfa-2a (40KD)/ribavirin

Ferenci, Péter; Fried, Michael; Shiffman, Mitchell L.; Smith, Coleman I.; Marinos, George; Gonçales, Fernando Lopes; Häussinger, Dieter; Diago, M.; Carosi, G.; Dhumeaux, Daniel; Craxı̀, Antonio; Chaneac, Monique; Reddy, K. Rajender

doi:10.1016/j.jhep.2005.04.009

Cited by 472 publications

(481 citation statements)

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“…Among non-LT HCV genotype 1 patients, attainment of viral response at week 4 is associated with almost 90% likelihood to achieve SVR. 8,15 However, the corresponding NPV is relatively low (74%) for RVR to be a clinically useful as a treatment "stopping" time point in the nontransplantation setting. 8,15 On the other hand, we found that the PPV and NPV of RVR in LT patients with HCV are higher.…”

Section: Discussionmentioning

confidence: 99%

“…8,15 However, the corresponding NPV is relatively low (74%) for RVR to be a clinically useful as a treatment "stopping" time point in the nontransplantation setting. 8,15 On the other hand, we found that the PPV and NPV of RVR in LT patients with HCV are higher. All patients with RVR subsequently achieved SVR after completing a full course of therapy (PPV ϭ 100%) while only 12% of those who did not have RVR achieved SVR (NPV ϭ 88%).…”

Section: Discussionmentioning

confidence: 99%

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Recurrent hepatitis C after liver transplantation: On-treatment prediction of response to peginterferon/ribavirin therapy

et al. 2007

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Sustained virologic response (SVR) in the treatment of recurrent hepatitis C virus (HCV) infection after liver transplantation (LT) remains suboptimal. We evaluated efficacy of pegylated interferon alfa (PEG) and ribavirin (RBV) (PEG/RBV) combination therapy in LT recipients with recurrent HCV and predictive values of rapid virological response (RVR) and early virologic response (EVR). Between January 2001 and October 2005, LT recipients with recurrent HCV were intended to be treated for 48 weeks with PEG/RBV combination therapy independent of genotype or virologic response [53 patients (79% genotype 1)]. On-treatment predictor of response at week 4 (RVR) was defined as undetectable HCV RNA, and at week 12 (EVR) as undetectable HCV RNA or a Ͼ2 log 10 drop from pretreatment viral load. SVR was seen in 19 (35%) patients. Patients with genotype 2/3 were more likely to achieve SVR than those with genotype 1 (87% versus 23%; P ϭ 0.001). The highest rate of SVR was seen in patients with RVR [specificity and positive predictive value (PPV) ϭ 100%] while the highest rate of treatment failure was seen in those who did not have EVR [sensitivity and negative predictive value (NPV) ϭ 100%]. The NPV of RVR to identify those who will not achieve SVR was also very high (88%). EVR had low PPV (63%) to identify those with SVR. In conclusion, PEG/RBV combination therapy is effective in the treatment of post-LT recurrent HCV. On-treatment virologic monitoring is highly predictive of SVR and may optimize the virologic response and minimize toxicity. Given its high PPV and NPV, RVR appears to be the most appropriate decision time point for continuation of therapy.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Recurrent hepatitis C after liver transplantation: On-treatment prediction of response to peginterferon/ribavirin therapy

et al. 2007

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“…The relationships between interferon dose and early phase HCV kinetics, including phase I and II slope and time to undetectable HCV RNA, 12,13 and early virological responses and SVR support such a rationale. 1,[14][15][16] Studies utilizing induction therapy with (peg)interferon in patients with genotype 1 CHC have yielded mixed results, with some patients demonstrating an enhanced SVR 4,5 and others not. [6][7][8][9][10][11] However, there has been no published randomized trial of high-dose induction therapy with peginterferon alfa-2a/b (PEG-IFN␣-2a/b) in a large population of treatment-naïve patients with genotype 1 CHC.…”

mentioning

confidence: 99%

Impact of High-Dose Peginterferon Alfa-2A on Virological Response Rates in Patients with Hepatitis C Genotype 1: a Randomized Controlled Trial† ‡

Roberts¹,

Weltman²,

Crawford³

et al. 2009

Hepatology

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This study tested the hypothesis that high-dose peginterferon alfa-2a (PEG-IFN␣-2a) for the first 12 weeks would increase early and sustained virological response (SVR) rates in patients with chronic hepatitis C genotype 1. Eight hundred ninety-six patients were randomized 1:1 to 360 g (n ‫؍‬ 448) or 180 g (n ‫؍‬ 448) PEG-IFN␣-2a weekly plus ribavirin at 1000-1200 mg/day for 12 weeks, followed by 36 weeks of 180 g PEG-IFN␣-2a weekly plus ribavirin at 1000-1200 mg/day with 871 patients evaluable for the intention-to-treat analysis. Virological responses were assessed by TaqMan (limit of detection 15 IU/mL) at week 4, 8, 12, 24, 48 (end of therapy), and 24 weeks following therapy (SVR). Undetectable hepatitis C virus RNA rates were significantly higher among patients receiving high-dose induction therapy at week 4 (36% versus 26%, P < 0.005), week 8 (61% versus 50%, P < 0.005), and week 12 (74% versus 62%, P < 0.005). However, SVR was not significantly different between patients receiving high-dose (53%) and standard (50%) therapy. Significant baseline prognostic factors for SVR included age, sex, race, histological stage, and viral load. SVR was considerably higher among patients with no or minimal fibrosis (64% and 60%, respectively) compared to those with severe fibrosis/cirrhosis (28% and 24%, respectively). The frequency of serious adverse events and drug discontinuations were similar in both groups, whereas PEG-IFN dose modification, weight and appetite reduction, and grade IV neutropenia were significantly higher in the induction arm.

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“…Biohemijska procena podrazumeva normalizaciju aktivnosti transaminaza (ALT), a histološka sa zloupotrebom narkotika i alkohola i dr. Na osnovu faktora, koji pozitivno utiču na efikasnost terapije, moguće je predvideti postizanje SVR. To su: ženski pol, životno doba (<40 god), G2 i G3, niska viremija pre terapije, brzi virusološki odgovor, odsustvo ciroze, steatoze jetre, gojaznosti, komorbiditeta, zloupotrebe alkohola i koinfekcija (HBV, HIV) [2,3,[6][7][8][9][10][11][12][13][14][15]. Ukupna doza primljenog RBV utiče na postizanje SVR i relaps.…”

Section: Uvodunclassified

“…Za razliku od njih kod bolesnika bez postignutog EVR samo je kod 14% terapija bila uspešna, odnosno postignut je SVR. Naši podaci u pogledu predviđanja postizanja SVR na osnovu EVR su u skladu sa podacima drugih ispitivanja [8,9,[11][12][13]30].…”

Section: Diskusijaunclassified

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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Predicting sustained virological responses in chronic hepatitis C patients treated with peginterferon alfa-2a (40KD)/ribavirin

Cited by 472 publications

References 18 publications

Recurrent hepatitis C after liver transplantation: On-treatment prediction of response to peginterferon/ribavirin therapy

Recurrent hepatitis C after liver transplantation: On-treatment prediction of response to peginterferon/ribavirin therapy

Impact of High-Dose Peginterferon Alfa-2A on Virological Response Rates in Patients with Hepatitis C Genotype 1: a Randomized Controlled Trial† ‡

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

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