Cutaneous Adverse Events in Chronic Hepatitis C Patients Treated With New Direct-Acting Antivirals

2015 ◽  
Vol 20 (1) ◽  
pp. 58-66 ◽  
Author(s):  
Parth Patel ◽  
Kunal Malik ◽  
Karthik Krishnamurthy

Background: Direct-acting antivirals (DAAs) are known to present with additional dermatological events over pegylated-interferon/ribavirin (Peg-IFN/RBV). Objective: A systematic review and meta-analysis was conducted to assess the incidence/risk of cutaneous adverse events (AEs) for simeprevir, sofosbuvir, ABT450/r-ombitasvir, dasabuvir, ledipasvir, daclatasvir, and asunaprevir. Methods: The databases searched included PubMed, Clinicaltrials.gov, and Clinicaloptions.com. Data on telaprevir and boceprevir were obtained from a previous study. Results: The incidences of cutaneous AEs were 34.3% (95% CI 18.4%-54.8%) for the old DAAs + Peg-IFN/RBV, 22.0% (95% CI 17.9%-26.8%) for the new DAAs + Peg-IFN/RBV, 9.8% (95% CI 8.6%-11.2%) for the DAAs + RBV, and 3.8% (95% CI 2.4%-6.1%) for DAAs only. Simeprevir + Peg-IFN/RBV was associated with an increased relative risk over Peg-IFN/RBV; RR = 1.319 (95% CI 1.026-1.697). Conclusion: Dermatological events are still an important issue for many of the new DAAs. Appropriate monitoring, management, and patient education are needed to minimize AEs and achieve HCV cure.

2019 ◽  
Vol 2019 ◽  
pp. 1-12 ◽  
Author(s):  
Ong The Due ◽  
Usa Chaikledkaew ◽  
Anne Julienne M. Genuino ◽  
Abhasnee Sobhonslidsuk ◽  
Ammarin Thakkinstian

Direct-acting antivirals (DAAs) are modern treatments for chronic hepatitis C infection, but majority of available evidence on its treatment effect covers genotypes 1 to 4. Therefore, the efficacy and safety of DAAs for genotypes 5 and 6 need to be analysed. Studies were identified from Medline, Scopus, and CENTRAL and a Chinese database CNKI, from inception until Dec 4, 2018. Clinical trials were included if they enrolled patients with genotypes 5 and/or 6 infection, any type of second-generation DAAs was studied, and sustained virological response was assessed at the 12th week after treatment (SVR12) as outcome measure. Meta-analysis using metaprop statistical program was applied for pooling proportions if data were sufficient (i.e., at least 2 studies). Thirteen studies were included in the analysis. Four studies assessed the efficacy of four DAA regimens in genotype 5 patients, which were mainly sofosbuvir (SOF) plus pegylated-interferon/ribavirin (PR) or other DAAs, with SVR12 ranging from 94.4% to 100%. Twelve studies assessed the efficacy of seven DAA regimens among genotype 6 patients, but only two DAA regimens (i.e., SOF + PR and SOF/ledipasvir) had sufficient data for pooling. The pooled SVR12 rates (95% CI) were 99.6% (92.2 to 100) for SOF + PR and 99.2% (96.5 to 100) for SOF/ledipasvir. No treatment-related serious adverse event was reported, while the nonserious adverse events were comparable to other genotypes. In conclusion, DAAs are effective and may be safe for the treatment of chronic hepatitis C genotypes 5 and 6. However, our evidence is based on noncomparative studies; hence, further larger-scale randomized controlled trials in these genotypes are still required.


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