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DAAs may benefit in long term for patients with decompensation
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The use of direct-acting antivirals as therapy for patients with hepatitis C virus infection and decompensated cirrhosis may lead to long-term improvement in liver function. In addition, the antivirals did not increase liver malignancy, according to results of a prospective study.
Michelle C.M. Cheung, BSc, MBBS, of the Liver Unit, Blizard Institute, Queen Mary University of London, and colleagues analyzed data of 406 patients with HCV enrolled in the HCV Research UK registry who received direct-acting antiviral (DAA) therapy from April to November 2014. These patients received either Harvoni (ledipasvir/sofosbuvir, Gilead Sciences) or Sovaldi (sofosbuvir, Gilead Sciences) plus Daklinza (daclatasvir, Bristol-Myers Squibb) with or without ribavirin for 12 weeks. The researchers sought to determine differences in specific outcomes, such as need for liver transplantation, development of hepatocellular carcinoma, occurrence of serious decompensation events, sepsis or hospitalization and MELD score between therapy initiation and up to 15 months’ posttreatment. The results then were compared with an untreated cohort of patients retrospectively studied over 6 months.
Among treated patients, 317 patients achieved sustained virological response at 24 weeks’ posttreatment. No late relapses were observed at 12 weeks’ posttreatment in patients who had decompensated cirrhosis at baseline.
In patients who achieved SVR24, 42.6% experienced at least one serious adverse events. There were nine deaths, 17 patients developed new HCC, 39 underwent liver transplant, and 52 presented with serious decompensated events. The transplant- and adverse events-free survival rate over 15 months was 57.4%.
The researchers noted that patients with Child Pugh C disease at baseline experienced more serious adverse events (17.8%) vs. those without the disease (2.7%; P < .0005) at baseline.
In patients treated with DAA therapy, the incidence of decompensated events decreased by 18% between 0 and 6 months and 7% between 6 and 15 months compared with a 28% reduction in untreated patients.
The researchers did not observe a significant difference in HCC incidence between groups (4% between 0 and 6 months, 2.5% between 6 and 15 months vs. 4% in untreated patients).
“The long-term benefits of viral eradication on liver function and the complications of portal hypertension remain unclear,” Cheung and colleagues wrote. “However, in our cohort, there was a marked reduction in liver-related serious adverse events in those patients who cleared virus, with decreasing adverse rates over time.
“We speculate that patients will continue to benefit long-term although further data will be required to confirm this.” – by Melinda Stevens
Disclosure: Cheung reports being funded by the National Institute for Health Research Doctoral Research Fellowship in the U.K. Please see the full study for a list of all other authors’ relevant financial disclosures.
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