Early versus delayed treatment of acute hepatitis C: Final results of the randomized controlled German HEP-NET acute HCV-III study

Deterding, Katja; Grüner, N; Buggisch, Peter; Galle, PR; Spengler, Ulrich; Hinrichsen, Holger; Berg, Thomas; Potthoff, Andrej; Malek, N; Diepolder, Helmut M.; Feyerabend, Sandra; Cornberg, Markus; Jung, M; Manns, MP; Wedemeyer, Heiner

doi:10.1055/s-0031-1295839

Cited by 3 publications

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“…However, in adherent patients, delayed combination therapy reflected the same efficacy of the immediate treatment strategy. 17 Last, the safety profile resulting from our study data is consistent with the known safety profile for Peg-IFN alpha-2b and RBV. No unexpected safety data emerged from the study and only 6 of the 16 drop-out patients discontinued treatment because of AEs.…”

Section: Discussionsupporting

confidence: 83%

“…In this study, immediate treatment (Peg‐IFN alpha‐2b 1.5 μg/kg/week for 24 weeks) versus a delayed treatment strategy was evaluated in symptomatic AHC patients. In the delayed treatment arm, patients still viremic after a 12‐week observation period received Peg‐IFN alpha‐2b plus RBV therapy; results indicated that at ITT analysis, SVR was 76% in symptomatic patients who received immediate treatment, whereas in patients treated after 12 weeks with combination therapy, lower response rates were obtained. However, in adherent patients, delayed combination therapy reflected the same efficacy of the immediate treatment strategy …”

Section: Discussionmentioning

confidence: 99%

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Acute hepatitis C: A 24-week course of pegylated interferon alpha-2b versus a 12-week course of pegylated interferon alpha-2b alone or with ribavirin

et al. 2014

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Therapy of acute hepatitis C (AHC)has not yet been standardized and several issues are still unresolved. This open, randomized, multicenter trial aimed to assess the efficacy and safety of a 24-week course of pegylated IFN (Peg-IFN) alpha-2b versus a 12-week course of Peg-IFN alpha-2b alone or with ribavirin (RBV) in AHC patients. One hundred and thirty HCV acutely infected patients who did not spontaneously resolve by week 12 after onset were consecutively enrolled and randomized to receive Peg-IFN alpha-2b monotherapy (1.5 lg/kg/week) for 24 or 12 weeks (arm 1, n 5 44 and arm 2, n 5 43, respectively) or in combination with RBV (10.6 mg/kg/day) for 12 weeks (arm 3, n 5 43). The primary endpoint was undetectable HCV RNA at 6-month posttreatment follow-up (sustained virological response; SVR). All patients were followed for 48 weeks after therapy cessation. HCV RNA levels were determined by real-time polymerase chain reaction (limit of detection: 15 IU/mL) at the central laboratory at baseline, week 4, end of treatment, and 6 and 12 months posttreatment. Using an intent-to-treat analysis, overall SVR rate was 71.5%. In particular, an SVR was achieved in 31 of 44 (70.5%), 31 of 43 (72.1%), and 31 of 43 (72.1%) patients in arms 1, 2, and 3, respectively (P 5 0.898). Sixteen patients (12.3%) prematurely discontinued therapy or were lost to follow-up; thus, sustained response rates with per-protocol analysis were 81.6%, 81.6%, and 81.6% for patients in arms 1, 2, and 3 respectively. With multivariate analysis, virologic response at week 4 of treatment was an independent predictor of SVR. Peg-IFN alpha-2b was well tolerated. Conclusion: Peg-IFN alpha-2b induces a high SVR in chronically evolving AHC patients. Response rates were not influenced by combination therapy or treatment duration. (HEPATOLOGY 2014;59:2101-2109 E ven though acute hepatitis C (AHC) incidence is gradually declining over the years in developed countries, 1 new infections continue to occur. The current major risk factors for hepatitis C virus (HCV) transmission are intravenous (IV) drug use, viral exposure during invasive diagnostic or therapeutic procedures, and sexual contacts. 1,2 Whereas the clinical course is normally mild, AHC has a high rate of progression to chronic HCV infection, ranging between 50% and 80%. 3 Treatment of AHC has been shown to be effective in reducing risk of progression to chronic HCV

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Section: Discussionsupporting

confidence: 83%

Section: Discussionmentioning

confidence: 99%

Acute hepatitis C: A 24-week course of pegylated interferon alpha-2b versus a 12-week course of pegylated interferon alpha-2b alone or with ribavirin

et al. 2014

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“…That Eastern Europe was not found to have lower rates of treatment is probably attributable to the inclusion criteria in this study; in particular, many patients from that region were excluded as they did not have available HCV RNA data. The observation that MSM were more likely to be treated than IDU can be explained by recent outbreaks of acute HCV infection in this patient population 33 , 34 , with treatment of acute HCV infection associated with much better cure rates than treatment of chronic HCV infection 35 , 36 , while MSM are also considered to be more adherent to treatment, with IDU often a contraindication of therapy.…”

Section: Discussionmentioning

confidence: 99%

Temporal changes and regional differences in treatment uptake of hepatitis C therapy in EuroSIDA

et al. 2013

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ObjectivesAll HIV/hepatitis C virus (HCV)-coinfected patients with chronic HCV infection and ≥ F2 fibrosis should be considered for HCV therapy. This study aimed to determine the rate of HCV treatment uptake among coinfected patients in Europe.MethodsEuroSIDA patients with viraemic HCV infection were included in the study. Poisson regression was used to identify temporal changes and regional differences in HCV treatment uptake.ResultsA total of 1984 patients were included in the study, with a median follow-up time of 168 months [interquartile range (IQR) 121–204 months]. To date, 501 (25.3%) HIV/HCV-coinfected patients have received HCV therapy. Treatment incidence rose from 0.33 [95% confidence interval (CI) 0.16–0.50] per 100 person-years of follow-up (PYFU) in 1998 to 5.93 (95% CI 4.49–7.38) in 2007, falling to 3.78 (95% CI 2.50–5.07) in 2009. After adjustment, CD4 cell count > 350 cells/μL [incidence rate ratio (IRR) 1.33 (95% CI 1.06–1.67) vs. CD4 count 200−350 cells/μL] and ≥F2 liver fibrosis [IRR 1.60 (95% CI 1.14–2.25; P = 0.0065) vs. < F2 fibrosis] were predictors of anti-HCV treatment initiation. However, 22% of patients who remain untreated for HCV, with fibrosis data available, had ≥F2 fibrosis and should have been considered for treatment, while only 36% of treated patients had ≥F2 fibrosis.ConclusionsAlthough treatment incidence for HCV has increased, there remain a large proportion of patients indicated for treatment who have yet to be treated.

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“…In the HIV-negative population, delaying treatment until 12 weeks after diagnosis does not compromise treatment success [114]. However a delay of more than 1 year after the onset of hepatitis leads to a reduction in sustained virological response (SVR) rates [115].…”

Section: Rationalementioning

confidence: 99%

British HIV Association guidelines for the management of hepatitis viruses in adults infected with HIV 2013

et al. 2013

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Early versus delayed treatment of acute hepatitis C: Final results of the randomized controlled German HEP-NET acute HCV-III study

Cited by 3 publications

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Acute hepatitis C: A 24-week course of pegylated interferon alpha-2b versus a 12-week course of pegylated interferon alpha-2b alone or with ribavirin

Acute hepatitis C: A 24-week course of pegylated interferon alpha-2b versus a 12-week course of pegylated interferon alpha-2b alone or with ribavirin

Temporal changes and regional differences in treatment uptake of hepatitis C therapy in EuroSIDA

British HIV Association guidelines for the management of hepatitis viruses in adults infected with HIV 2013

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