Favorable adverse event profile of sofosbuvir/ribavirin compared to boceprevir/interferon/ribavirin for treatment of hepatitis C

Narayanan, Shivakumar; Townsend, Kerry; Macharia, Thomas; Majid, Adrian; Nelson, Amy; Redfield, Robert; Kottilil, Shyam; Talwani, Rohit; Osinusi, Anu

doi:10.1007/s12072-014-9574-0

Cited by 10 publications

(6 citation statements)

References 20 publications

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“…[25] In addition, hematologic abnormalities were more prominent among the triple-therapy group in other studies, for example, Satsangi et al, [32] and Wei et al [33] Adding IFN to other DAAs was associated with anemia and leucopenia in other studies. [37,38] In contrast to our study, Ahmed et al found no significant effect of adding IFN to a SOF--RBV regimen on hemoglobin and leucocyte levels. [31] In our triple-therapy group, the drop of HCV RNA was greater: mean values of HCV RNA were lower among the triple-therapy group within 4 weeks of treatment, that is, (354.16 ± 1444.84 IU/mL, 27.5 ± 122.98 IU/mL) for double and triple therapy respectively.…”

Section: Discussioncontrasting

confidence: 99%

Prediction of response to sofosbuvir-based therapy using serum interleukin-12 and single nucleotide polymorphism of the interleukin 28B gene as predictive factors in HCV positive genotype-4 patients

Mohamed Abdelnajid,

Elmowafy,

Rostaing

et al. 2023

Medicine

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Some hepatitis-C virus patients have resistance to direct-acting-antivirals (DAAs). Genetic polymorphisms have been associated with drug resistance. This study aimed to evaluate the role of interleukin (IL)-28B gene polymorphism and IL-12 levels as predictors for a response to sofosbuvir/ribavirin (SOF/RBV) with (triple-therapy) or without (dual-therapy) Peg-alpha-interferon. 92 hepatitis C virus (HCV)/RNA (+)-patients treated with dual (n = 72) or triple (n = 20) therapy. IL28B genetic polymorphism and IL-12 level assessments. 30.4% of the patients were IL28B C/C genotype, 56.5% C/T-genotype, and 13% T/T-genotype. Mean baseline IL-12 levels were 27.5 ± 3.0 pg/mL. Rapid viral response was achieved in 86/92 patients. All patients achieved end-of-treatment virologic response. The 12- and 24-week sustained virologic responses (SVR) were achieved in 76 patients (82.6%), that is, a relapse was found in 16 patients (17.4%). 8 and 12-weeks after antiviral therapy, IL-12 levels decreased significantly, and became comparable to those of the control-group. That drop in IL-12 levels was similar across the dual- and triple-therapy patients. Finally, logistic regression analysis showed that the increase in baseline aspartate aminotransferase (AST) and T/T genotyping had an independent effect on increasing the probability a SVR failing in both dual- and triple-therapy groups (P = .0007 and P = .02, respectively). Single-nucleotide polymorphism (SNP) in IL-28B and IL-12 levels play roles as predictors in DAAs resistance.

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Section: Discussioncontrasting

confidence: 99%

Prediction of response to sofosbuvir-based therapy using serum interleukin-12 and single nucleotide polymorphism of the interleukin 28B gene as predictive factors in HCV positive genotype-4 patients

Mohamed Abdelnajid,

Elmowafy,

Rostaing

et al. 2023

Medicine

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“…This strongly suggests that ITPA deficiency is still predictive of anaemia even when RBV is combined with DAAs with a poor haematological tolerance as recently reported in an HCV-monoinfected population treated with TLV [28]. Moreover, even though RBV is combined with a second-generation DAA like sofosbuvir with a better haematological tolerance profile, anaemia can still occur in 25% of patients [29]. As the choice of RBV dose is not currently validated in these new therapies with DAAs, ITPA genotyping may be still of interest to detect patients early with a higher risk of developing severe anaemia and would be useful to recommend either RBV dose adjustment or a specific follow-up during therapy.…”

Section: Discussionsupporting

confidence: 53%

ITPA Deficiency and Ribavirin Level are Still Predictive of Anaemia in HCV–HIV-Coinfected Patients Receiving Ribavirin Combined with a First-Generation DAA (ANRS HC27 Study)

et al. 2016

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“…Neutropenia still occurs with any PegIFN containing regimen regardless of the DAA included [42][43][44][45]. IFN-free regimens do not cause neutropenia suggesting that PegIFN is the cause rather than CHC, DAA or RBV [43].…”

Section: Discussionmentioning

confidence: 97%

High Risk of Infection During Triple Therapy with First- Generation Protease Inhibitors: A Nationwide Cohort Study

Berden

Zwietering

Maan

et al. 2016

JGLD

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Background & Aims: Peginterferon (PegIFN) remains the backbone of therapy for chronic hepatitis C (CHC) in economically constrained regions. However, PegIFN may cause neutropenia and addition of a protease inhibitor can increase the likelihood of neutropenia. The aims of this study were to assess the occurrence of clinically relevant infections during first-generation protease inhibitor based therapy and its risk factors as well as the relation to treatment-induced neutropenia. Methods: This multicenter (n=45) retrospective cohort study included CHC patients treated in the Netherlands. Based on absolute neutrophil count, categories of neutropenia were defined as: severe (<500/μL), moderate (500-750/μL) and mild (750-1500/μL). Likewise, infections were classified as severe (intravenous antibiotics/ hospitalization) and moderate (anti-infective treatment). We assessed risk factors for infections using multivariable regression analysis adjusting for multiple measurements. Results: We included 467 CHC patients, 319 (68%) were male and 111 (24%) had cirrhosis. A total of 185 clinically relevant infections (34 severe) occurred in 145 patients (31%). During treatment 310 patients experienced neutropenia (severe, n=34). Multivariable analysis identified female sex (OR 1.7, 95%CI 1.2- 2.5), chronic obstructive pulmonary disease (COPD) (OR 2.7, 95%CI 1.6- 4.5) and diabetes mellitus (OR 1.7, 95%CI 1.0-3.0) as risk factors for infections. Neutropenia at the previous visit was not associated with infection (univariable analysis: OR 0.9, 95%CI 0.6-1.3). Conclusion: This study shows that therapy with first generation protease inhibitors was complicated by an infection in 31% of patients. Not neutropenia, but female sex, COPD and diabetes mellitus were independent risk factors for infection. These patients should be monitored carefully once a PegIFN regimen is initiated. Abbreviations: ANC: absolute neutrophil count; CHC: chronic hepatitis C; COPD: chronic obstructive pulmonary disease; DAAs: direct acting antivirals; DM: diabetes mellitus; HCV: hepatitis C virus; PegIFN: pegylated interferon alpha; PI: protease inhibitor; UTI: urinary tract infection.

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Favorable adverse event profile of sofosbuvir/ribavirin compared to boceprevir/interferon/ribavirin for treatment of hepatitis C

Cited by 10 publications

References 20 publications

Prediction of response to sofosbuvir-based therapy using serum interleukin-12 and single nucleotide polymorphism of the interleukin 28B gene as predictive factors in HCV positive genotype-4 patients

Prediction of response to sofosbuvir-based therapy using serum interleukin-12 and single nucleotide polymorphism of the interleukin 28B gene as predictive factors in HCV positive genotype-4 patients

ITPA Deficiency and Ribavirin Level are Still Predictive of Anaemia in HCV–HIV-Coinfected Patients Receiving Ribavirin Combined with a First-Generation DAA (ANRS HC27 Study)

High Risk of Infection During Triple Therapy with First- Generation Protease Inhibitors: A Nationwide Cohort Study

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