Today I continue with my summaries of some noteworthy research presented at the annual Liver Meeting. Yesterday I focused on non-alcoholic fatty liver disease (NAFLD). Today I begin with an important pediatric study, showing that Harvoni is safe to use to treat children 3 to 6 years old.  Then I discuss hepatitis C treatment in adults, particularly its value beyond efficacy.  

Note that conference posters are preliminary investigations, and are not conclusive until the data are published in a peer-reviewed journal.

Abstract: # 184 Ledipasvir/Sofosbuvir for 12 Weeks Is Safe and Effective in Children 3 to <6 Years Old with Chronic Hepatitis C Virus Infection - Kathleen B. Schwarz, et al.

Sofosbuvir‐based regimens (Harvoni or Solvadi/ribavirin) have been approved for adolescents with hepatitis C who are aged 12 to <18 years. The current standard of care recommends deferring treatment in children aged 3 to 11 years.

This study evaluated the safety and efficacy of an all‐oral treatment using Harvoni in 34 children with HCV who are 3 to <6 years old. Children from Australia, Europe and North America with genotype 1 or 4 were enrolled and they received 12 weeks of Harvoni using weight‐based dosing.

Results: Preliminary data reported no virologic failures. A 3‐ year old patient discontinued treatment after 4 days due to mild vomiting and abnormal drug taste.

Conclusion: Harvoni was well tolerated, supporting its use as a treatment option for children 3 to <6 years old.

My Comments: Hooray. This extends hope to parents and young children.

Abstract: # 145The Impact of HCV Sustained Virologic Response from Direct Acting Antiviral and Interferon-Based Treatments on Mortality in a Large Population Based Cohort Study - Naveed Janjua, et al.

This study examined the effect of successful hepatitis C treatment (sustained virologic response or SVR) on mortality reduction. Both direct-acting antiviral (DAA) and interferon‐based treatments were included in this analysis. Researchers used a large Canadian database of approximately 1.3 million individuals tested for HCV since 1990, assessing all‐cause mortality risk among those who did and did not achieve SVR.

Results: Of 14,033 eligible individuals, 5,169 received DAAs while 8,864 received interferon‐based treatments; 4765 achieved SVR with DAAs and 6538 achieved SVR with interferon based treatment.

A successful treatment outcome correlated with a limited decline in survival among those without cirrhosis.  Listed from lowest survival to highest, the features that affected survival rate were:

  • Cirrhosis no‐SVR
  • SVR/cirrhosis
  • No‐SVR/no‐cirrhosis

The reduction in mortality was similar among those with cirrhosis treated with either DAAs or interferon.  Compared to no‐SVR from interferon, SVR from DAA and interferon-based treatments resulted in similar mortality reductions. Mortality was lower in those with cirrhosis  than those without it.

Conclusion: Both DAA and interferon‐based SVR substantially reduces all‐cause mortality, with lower reductions in those with cirrhosis. These results also indicate that early treatment could further improve survival.

My Comments: The evidence overwhelmingly supports every attempt to offer hepatitis C treatment, and to increase the odds of success by offering it before there is significant liver damage.

Abstract: # 146 Impact of All-Oral Direct-Acting Antivirals on Clinical and Economic Outcomes in Chronic Hepatitis C Virus-Infected Patients in the U.S. - Haesuk Park, et al.

We have seen similar studies to this one, so I am not including details about it, other than the summary: “…all‐oral DAA treatment for HCV infection was associated with a decreased risk of developing liver complications resulting in decreased healthcare costs, especially in cirrhotic patients.”

Abstract: # 148 Sustained Virologic Responses Reduces the Incidence of Extrahepatic Manifestations in Chronic Hepatitis C Infection - Carmine Rossi, et al.

In addition to attacking the liver, chronic hepatitis C virus creates other problems, known as extrahepatic manifestations. This large Canadian study assessed whether a sustained virologic response (SVR) to HCV treatment affected extrahepatic manifestations. Researchers identified individuals who underwent interferon‐based therapy between 1999 and 2014. They examined the prevalence of diabetes, chronic kidney disease or end‐stage renal disease, ischemic or hemorrhagic stroke, ischemic heart disease, osteoporosis with fractures, and mood disorders, including depression. They compared post‐treatment incidence rates and cumulative incidence for each extrahepatic manifestation, between SVR and non‐SVR individuals, starting 12 weeks after therapy.

Results: All extrahepatic manifestations were lower among those with SVRs.

Conclusion: SVR leads to substantial reduction in extrahepatic manifestations. Treating more people is expected to impact extrahepatic manifestations as well as lead to improved liver outcomes.

My Comments: Studies show that SVRs using direct-acting antivirals have similar results. Here are two similar studies:

Abstract: # 149 Improvements in Symptoms Shortly Following Viral Cure for Chronic Hepatitis C: A Large Multi-Site Clinical Cohort Study – Donna M. Evon, et al.

This study, conducted in the United States, found similar results to those reported in abstract # 148. “In clinical practice, substantial improvements in several symptoms were reported by patients after achieving SVR and were predicted by age, sex, disability, and psychosocial vulnerability.”

Abstract: # 150 Quality of Life in Patients with Psychiatric Disorders: Pooled Analysis from Glecaprevir/Pibrentasvir Registrational Studies - Patrice Cacoub, et al.

This study reported results similar to those presented at past liver meetings. These Swiss researchers found that HCV patients with psychiatric disorders had positive psychological outcomes after treatment.