Safety and efficacy of treatment with pegylated interferon alpha-2a with ribavirin in chronic hepatitis C genotype 4

Urquijo, Juan José; Diago, M.; Boadas, Jaume; Planas, Ramón; Solá, Ricard; Olmo, Juan A. del; Crespo, Javier; Erdozain, J. C.; Antón, M.D.; Arocena, C; Suárez, Dolores; Giné, J.; Barrera, J.M.; Gracia-Samaniego, Javier; Pérez, Ricardo; Dalmau, Blai; Montoro, Miguel

doi:10.1016/s1665-2681(19)31382-1

Cited by 9 publications

(5 citation statements)

References 33 publications

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“…Sub-group-analysis by prospective and retrospective studies showed similar SVR rates: 53% (CI: 50–56%) in forty-three prospective studies[10, 11, 13–16, 18, 27, 28, 34, 38–42, 46, 48, 53–56, 62, 63, 65–67, 69, 72, 73, 75–78, 80, 81, 83, 84, 88, 90, 91, 93, 95, 96] and 53% (CI: 46–59%) in eight retrospective studies[12, 35, 37, 45, 59, 71, 79, 85]. Significant heterogeneity was observed in both sub-group analyses with I 2 >50% (Figure 4).…”

Section: Resultsmentioning

confidence: 95%

“…There were 51 studies with a total of 11,102 HCV-4 patients included in the primary analysis (Table 1)[10–16, 18, 27, 28, 34, 35, 37–42, 45, 46, 48, 53–56, 59, 62, 63, 65–67, 69, 71–73, 75–81, 83–85, 88, 90, 91, 93, 95, 96]. The majority of studies (40/51, 78%) originated from the Middle East[10–13, 15, 16, 18, 27, 28, 34, 35, 37, 40–42, 45, 46, 53–56, 59, 62, 63, 66, 67, 69, 72, 75, 78, 80, 81, 83–85, 88, 91, 95] and Europe (9/51, 18%)[14, 38, 39, 65, 71, 76, 79, 93, 96].…”

Section: Resultsmentioning

confidence: 99%

“…The majority of studies (40/51, 78%) originated from the Middle East[10–13, 15, 16, 18, 27, 28, 34, 35, 37, 40–42, 45, 46, 53–56, 59, 62, 63, 66, 67, 69, 72, 75, 78, 80, 81, 83–85, 88, 91, 95] and Europe (9/51, 18%)[14, 38, 39, 65, 71, 76, 79, 93, 96]. One originated in Cameroon[77] and one multi-center study was conducted in 19 countries[73].…”

Section: Resultsmentioning

confidence: 99%

“…When comparing RCTs versus non-RCT studies, we observed a pooled SVR rate of 60% (CI: 53–68%) in the six RCTs[10, 13, 16, 18, 54, 93] compared to 52% (CI: 49–55%) in 45 non-RCTs[11, 12, 14, 15, 27, 28, 34, 35, 37–42, 45, 46, 48, 53, 55, 56, 59, 62, 63, 65–67, 69, 71–73, 75–81, 83–85, 88, 90, 91, 95, 96] (Figure 3). This finding was statistically significant with p =0.043.…”

Section: Resultsmentioning

confidence: 99%

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Meta-analysis

Yee

Nguyen

Zhang

et al. 2014

European Journal of Gastroenterology &Amp; Hepatology

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Background The burden of hepatitis C virus genotype 4 (HCV-4) is high in Africa and East Mediterranean countries. Previous reports estimate sustained virologic response (SVR) rates in HCV-4 to be ~20–70%. However, many of these studies are limited by different study designs and small sample sizes. Aim Our aim was to evaluate treatment outcome and host/viral factors on SVR in HCV-4 patients treated with pegylated interferon and ribavirin (PEG IFN+RBV) in a systematic and quantitative fashion. Methods A comprehensive literature search in MEDLINE and EMBASE for ‘genotype 4’ was conducted in November 2013. Abstracts from AASLD, APASL, DDW, and EASL in 2012/2013 were reviewed. Inclusion criteria were original studies with ≥25 treatment-naïve HCV-4 patients treated with PEG IFN+RBV. Exclusion criteria were co-infection with HIV, HBV, or other genotypes. Effect sizes were calculated using random-effects models. Heterogeneity was determined by Cochrane Q-test (p-value <0.05) and I-squared statistic (>50%). Results We included 51 studies (11,102 HCV-4 patients) in the primary analysis. Pooled SVR was 53% (95% CI: 50–55%) (Q-statistic = 269.20, p<0.05; I2 = 81.43). On sub-group analyses, SVR was significantly associated with lower viral load, OR 3.05 (CI 1.80–5.17, p<0.001); mild fibrosis, OR 3.17 (CI 2.19–4.59, p<0.001); and favorable IL28B polymorphisms, rs12979860 CC versus CT/TT, OR 4.70 (CI 2.87–7.69, p<0.001), and rs8099917 TT versus GT/GG, OR 5.21 (CI 2.31–11.73, p<0.001). Conclusions HCV-4 patients treated with PEG IFN+RBV may expect SVR rate of ~50%. Lower viral load, mild fibrosis, and favorable IL28B (rs12979860 CC and rs8099917 TT) are positively associated with SVR.

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Section: Resultsmentioning

confidence: 95%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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Meta-analysis

Yee

Nguyen

Zhang

et al. 2014

European Journal of Gastroenterology &Amp; Hepatology

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“…Papastergiou et al received a similar result in Greek patients (43.6%) [ 13 ]. By contrast, in a Spanish study 52.7% of treated patients achieved SVR24 [ 17 ]. Here, the response rate was lower, and only 41.1% of patients had SVR24.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of pegylated interferon α and ribavirin in patients monoinfected with HCV genotype 4

Kozielewicz

Grabińska²,

Madej³

et al. 2018

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IntroductionDual therapy (PegIFN and ribavirin) (DT) was the standard of care in patients infected with HCV genotype 4 (HCV-4) until 2014. Nowadays, new treatment options are available including interferon (IFN)-based and other IFN-free regimens.AimTo assess the efficacy (SVR24) and safety of DT and the selected predictor factors of SVR in HCV-4 infected patients.Material and methodsOne hundred and twelve patients (62 men) of median age 23 years were treated with DT for 48/72 weeks (107/5) in the years 2006–2014. Most of them were treatment naïve (80.4%) and with fibrosis F ≤ 2 (83.1%). To select a subset of independent predictors of SVR Logistic Regression Analysis was applied.ResultsSVR24 was achieved in 46/112 (41.1%) patients. The mean viral load was 5.55 log10 IU/ml. Lack of therapy experience increases the odds of achieving SVR (OR = 4.17; 1.04–16.67), whereas more advanced fibrosis and higher baseline viral load tend to decrease the probability of SVR (OR = 0.05; 0.01–0.52 and OR = 0.44; 0.17–1.13, respectively). In contrast, the weight loss is associated with higher probability of virological response (OR = 4.31; 1.37–13.60). Two hundred and seventy-nine adverse events (AEs) were reported in 96 individuals. The rates and types of AEs were similar in patients treated with PegIFN-α2a/RBV and PegIFN-α2b/RBV. Overall, 3 (2.7%) patients discontinued therapy prematurely because of serious AEs.ConclusionsSVR24 was low. Loss of weight was a new positive predictive factor of SVR found in our study. Most of the AEs were typical of those previously reported for DT.

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