Currently Viewing:
Newsroom
Currently Reading
Continuing Systemic Treatment in Cutaneous T-cell Lymphoma Associated With Lower Healthcare Costs
March 20, 2019 – Mary Caffrey
Adherence to COPD Treatment Lower With 3 Inhalers Compared With 2
March 20, 2019 – Jaime Rosenberg
CDC Says New HIV Transmissions Stem From Lack of Treatment, Unawareness of Infection
March 20, 2019 – Wallace Stephens
What We're Reading: Postpartum Depression Drug Approval; Marijuana and Psychosis; Mississippi Abortion Bill
March 20, 2019 – AJMC Staff
AHIP, Employer Groups Seek Congressional Action on Surprise Medical Bills
March 19, 2019 – Allison Inserro
The Current Landscape of CGRP Inhibitor Coverage
March 19, 2019 – Samantha DiGrande
COPD Symptoms Improved in Case Study of Endobronchial Valve Treatment
March 19, 2019 – Wallace Stephens
What We're Reading: Ohio Work Requirements; Healthcare Data Breaches; Patients Try to Lower Drug Costs
March 19, 2019 – AJMC Staff
MS May Not Flare Post Pregnancy, Study Finds
March 18, 2019 – Samantha DiGrande

Real-World HCV Study Finds Sofosbuvir/Ledipasvir Safe, Effective

Samantha DiGrande
A recent study looked to evaluate the real-world effectiveness of hepatitis C virus (HCV) treatment in patients with genotype 1 (HCV-1) infection.
In Taiwan, real-world data on the effectiveness and safety of sofosbuvir/ledipasvir (SOF/LDV) with or without ribavirin (RBV) in patients with hepatitis C virus (HCV) are limited. A recent study looked to evaluate the real-world effectiveness of HCV treatment in patients with genotype 1 (HCV-1) infection.

The trial retrospectively enrolled 273 patients with chronic HCV-1 who received SOF/LDV for 8, 12, or 24 weeks with or without RBV. Among the 88 (32.2%) patients receiving RBV, all received the treatment for 12 weeks, including 25 who underwent liver transplantation, 25 with decompensated cirrhosis, and 39 with compensated cirrhosis.

Additionally, of the 272 patients with available HCV RNA data at week 4 of treatment, 218 (80.2%) of them had undetectable serum HCV RNA. The study identified 2 end points to evaluate effectiveness: evaluable population (EP) analysis, which assessed sustained virologic response at 12 weeks of therapy (SVR12) for patients who received at least 1 dosage of treatment, and per-protocol population (PP) analysis, which assessed SVR12 by excluding non-SVR12 patients due to nonvirologic failure. Patients were considered failing to achieve SVR12 if they lacked data.

Overall, the study found that sustained virologic response rates at 12 weeks of therapy were 96.7% (264 of 273 patients; 95% CI, 93.9%-98.3%) by EP analysis, and 97.5% (264 of 271 patients; 95% CI, 94.8%-98.8%) by PP analysis. Among patients who failed to achieve SCR12, 7 (2.6%) relapsed and 2 (0.7%) were lost to follow up.

In terms of safety, 12 (4.4%) of patients experienced on-treatment serious adverse events. The most common adverse events included fatigue (27.1%), headache (20.5%), nausea (17.9%), and insomnia (13.9%).

Overall, the researchers were able to conclude that SOF/LDV treatment with or without RBV had “excellent” safety and effectiveness for patients with HCV-1 infection in Taiwan. The study authors wrote that SOF/LDV treatment with or without RBV for 9 to 24 weeks is well tolerated and achieves a high SVR12 rate, which may improve the care of such patients in Taiwan.

Reference

Liu CH, Liu CJ, Su TH, et al. Real-world effectiveness and safety of sofosbuvir and ledipasvir with or without ribavirin for patients with hepatitis C virus genotype 1 infection in Taiwan [published December 21, 2018]. PLoS One. doi: 10.1371/journal.pone.0209299.

Related Articles

Sofosbuvir-Based Therapy Safe in Patients With HCV and Certain Cancers
Glecaprevir/Pibrentasvir Is Safe, Effective in Treatment of HCV in Real-World Setting
Oregon Medicaid Program to End HCV Treatment Rationing in 2019
 
Copyright AJMC 2006-2018 Clinical Care Targeted Communications Group, LLC. All Rights Reserved.
x
Welcome the the new and improved AJMC.com, the premier managed market network. Tell us about yourself so that we can serve you better.
Sign Up
×

Sign In

Not a member? Sign up now!