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Ledipasvir–sofosbuvir combination effective, safe in chronic hepatitis C genotype 1 infection

18 Oct 2018

Combination therapy with the NS5A inhibitor ledipasvir and NS5B inhibitor sofosbuvir (LDV/SOF) appears to be highly effective in the management of chronic hepatitis C virus (HCV) genotype 1 (GT1) infection, yielding a sustained virologic response (SVR) of >90 percent without increasing the incidence of serious adverse events, according to data from a real-world Japanese cohort.

Researchers reviewed the medical data of 1,461 GT1-infected patients (mean age, 69 years; cirrhosis, 23.8 percent; history of treatment for hepatocellular carcinoma [HCC], 10.9 percent), treated with LDV/SOF for 12 weeks. Evaluations included the rate of SVR at 12 weeks post-treatment (SVR12), incidence of adverse events and serum markers of HCC.

The overall SVR12 rate was 98.4 percent. Risk factors for treatment failure were cirrhosis (odds ratio, 4.19; p=0.014) and resistance-associated substitutions (RASs) in NS5A at baseline (odds ratio, 7.78; p=0.0004).

The SVR12 rates were 93.0 percent among patients with cirrhosis and NS5A RASs and 100 percent among those without cirrhosis or NS5A RASs.

In the group of patients who achieved SVR, reductions from baseline to end of treatment were observed in the levels of alpha-fetoprotein (AFP; from 13.4 to 6.0 ng/mL; p<0.0001), AFP-L3 (from 2.2 percent to 1.5 percent; p<0.005) and Mac-2 binding protein glycosylation isomer (M2BPGi; from 3.6 to 2.0 cutoff index; p<0.0001).

Adverse events occurred rarely and independent of age. Furthermore, there were no reductions observed in estimated glomerular filtration rate in patients with baseline chronic kidney disease stage 3.

Researchers noted that while the study specifically focused on SVR12 and did not analyse long-term prognosis including HCC occurrence, the finding of reduced M2BPGi in patients who achieved SVR suggests that viral eradication by LDV/ SOF therapy has the potential to reduce HCC risk.

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Most Read Articles
Tristan Manalac, 06 Nov 2018
Intravenous cefiderocol thrice daily is noninferior to imipenem-cilastatin for treating complicated urinary tract infection (UTI) patients with multidrug-resistant, Gram-negative infections, according to a recent study.
01 Nov 2018
Genotype 4 hepatitis E virus infection does not appear to be correlated with acute, nontraumatic neurologic disorders, according to a recent China study.
01 Nov 2018
In patients with genotype 3 hepatitis C virus (HCV) infection and decompensated cirrhosis, the rate of achieving sustained virologic response 12 weeks after treatment (SVR12) is high with treatment regimens consisting of sofosbuvir and velpatasvir with or without ribavirin, according to the results of a phase II trial. However, the rate appears to be lower in the subgroup of patients with baseline resistance-associated substitutions in nonstructural protein 5A.
07 Nov 2018
In infants with early-life acute respiratory infection (ARI) with respiratory syncytial virus (RSV), elevated nasopharyngeal Lactobacillus levels protect against wheezing illnesses at 2 years of age, a recent study has found.