Efficacy and Safety of Ledipasvir/Sofosbuvir with and without Ribavirin in Patients with Chronic Hepatitis C Virus Genotype 1 Infection: a meta-analysis

Tao, Tingting; Jiang, Xuehua; Chen, Yuehong; Song, Yiran

doi:10.1016/j.ijid.2016.12.023

Cited by 21 publications

(16 citation statements)

References 27 publications

(16 reference statements)

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“… 4 , 5 , 6 Lower rates of effectiveness were reported in urban patients in minority racial/ethnic groups. 7 Thus, the advent of newer direct-acting antivirals (DAAs) that could be administered over 8 to 12 weeks with few significant adverse effects 8 , 9 and sustained virologic response of 93% to 99% across different target populations and treatment regimens 10 , 11 , 12 was considered a substantial breakthrough in treating HCV. 13 …”

Section: Introductionmentioning

confidence: 99%

Assessing the Safety of Direct-Acting Antiviral Agents for Hepatitis C

et al. 2019

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Key Points Question Are patients with hepatitis C who receive direct-acting antivirals at increased risk for adverse events compared with those who do not receive these agents? Findings In this cohort study of 33 808 patients in 3 health systems, direct-acting antiviral exposure was associated with lower odds of experiencing the following adverse events: death, multiple organ failure, hepatic decompensation, acute-on-chronic liver event, and arrhythmia. Meaning Concerns about safety risks based on analyses of the US Food and Drug Administration’s Adverse Events Reporting System did not appear to be confirmed, suggesting that dispensed direct-acting antivirals may be safe for patients with hepatitis C.

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Section: Introductionmentioning

confidence: 99%

Assessing the Safety of Direct-Acting Antiviral Agents for Hepatitis C

et al. 2019

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“…The adverse event may be related to certain drugs. Tao et al reported significant increase in the overall AE and serious AE rates when adding RBV to the LDV/SOF dual therapy . This provide another evidence against using RBV with other therapeutic regimens.…”

Section: Discussionmentioning

confidence: 95%

“…Although the meta‐analysis about the role of RBV in the regimen was not done based on the stratification of subpopulation with different viral loads, the combination of all three high‐potency DAAs might have similar effects and explain the unnecessary role of RBV in the regimen. Similarly, a recent meta‐analysis investigating the efficacy of LDV and SOF with or without RBV found that adding RBV to this regimen neither improved the viral response nor decreased the virologic breakthrough . Furthermore, Mizokami et al reported that adding RBV to the LDV/SOF decreased the SVR 12 from 100% to 91.7% among treatment‐naïve patients with cirrhosis.…”

Section: Discussionmentioning

confidence: 99%

Beclabuvir in combination with asunaprevir and daclatasvir for hepatitis C virus genotype 1 infection: A systematic review and meta‐analysis

Ahmed

Doheim

Mattar

et al. 2018

Journal of Medical Virology

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Daclatasvir, asunaprevir (ASV), and beclabuvir (BCV) are direct-acting antivirals (DAAs) for patients with hepatitis C virus genotype 1 infection. This systematic review and meta-analysis investigating the efficacy and safety of this three-drug combination in HCV genotype 1 infection. Eleven electronic search engines were searched for relevant publications. Studies were screened for eligibility and data was extracted. The outcomes were pooled as event rate and risk ratio (RR). The protocol was registered in PROSPERO (CRD42017054391). Among the included six studies, five studies were included for the meta-analysis (n = 1261). The three-drug combination showed a high response rate in naïve patients with sustained virologic response at week-12 posttreatment (SVR ) rate = 95.7% (95%CI [93.8-97.1]) and no difference detected by adding ribavirin (RBV) (the pooled RR = 0.98, 95%CI [0.90-1.08], P = 0.70) or comparing with interferon-experienced patients (RR = 1.02, 95%CI [0.98-1.07], P = 0.31) regardless the genotype 1 subtypes or IL28B genotype. Treatment failure was minimal and showed no difference regarding the previous comparisons. Increasing the dose or the duration did not show a significant increase in the efficacy. In conclusion, this analysis showed high response rates in HCV genotype 1-infected patients treated with daclatasvir, ASV, and BCV irrespective of RBV use, prior interferon-based therapy, or restriction on non-cirrhotic patients, IL28B genotype, or baseline resistance-associated variants.

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“…In conclusion, our results showed that a regimen of SOF and NS5A inhibitors without RBV for 12 weeks could be sufficient to ensure the effective treatment of more than 93% of liver recipients. The response rates to DAA combination therapy in LT patients were similar to those observed in the nontransplanted population . According to these findings, LT recipients should not be considered as a “difficult‐to‐treat” population.…”

Section: Discussionmentioning

confidence: 99%