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EASL 2016: DAAs for Hepatitis C Achieve Excellent Outcomes in Real-World Settings

Hepatitis C therapy with direct acting antivirals (DAAs) is as effective in real-world settings as it was in clinical trials, according to U.S. research presented at the International Liver Congress in Barcelona last week. Investigators from the Department of Veteran Affairs (VA) analyzed outcomes in over 9000 patients treated with DAA combinations. Outcomes were excellent, with 2 combinations achieving cure rates of 93%, similar to those seen in randomized studies with strict eligibility criteria and close follow-up.

[Produced in collaboration with infohep.org]

The development of DAAs has revolutionized hepatitis C treatment and care. The aim of treatment is an undetectable viral load 12 weeks after the completion of therapy, usually called a sustained virological response (SVR12). Several DAA regimens have performed well in clinical trials, achieving SVR12 rates of 90% or more. However, there are limited data on the effectiveness of DAAs in routine care settings, and it is therefore unclear if the impressive results observed in clinical trials can be replicated in the real world.

Researchers from the VA therefore analyzed the records of 9604 people with hepatitis C who completed therapy with a DAA combination and were followed until 12 weeks after the completion of treatment.

The patients received 1 of 3 regimens:

• Simeprevir (Olysio) + sofosbuvir (Sovaldi): 3064;
• Sofosbuvir/ledipasvir (Harvoni): 5524;
• Ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira Pak or "3D": 1012.

The overwhelming majority (96%) of patients were male, 65% were between 60 and 65 years of age, and 75% had hepatitis C virus (HCV) genotype 1. Patients with more advanced liver disease at baseline were more likely to have received therapy with simeprevir plus sofosbuvir, the first of the study regimens to come to market.

All 3 combinations achieved impressive SVR12 rates:

• Simeprevir + sofosbuvir: 87.3%;
• Sofosbuvir/ledipasvir: 93.2%;
• 3D: 93.4%.

After controlling for baseline characteristics, people taking sofosbuvir/ledipasvir and people taking the 3D combination were significantly more likely to achieve SVR12 than people taking simeprevir plus sofosbuvir.

The severity of baseline liver disease affected treatment outcomes, with more severe disease associated with lower chances of achieving SVR12. Non-genotype 1 infection was also associated with reduced odds of sustained viral suppression. Encouragingly, coinfection with HIV did not affect treatment outcomes.

The investigators concluded that use of DAA combinations in routine settings has been found "to fulfill their promise of greater than 90%, as first documented in randomized clinical trials."

4/22/16

Reference

J McCombs, J McGinnis, S Fox, et al. Analysis of the real-world effectiveness of direct acting antiviral treatments for hepatitis C in a large population. EASL International Liver Congress 2016. Barcelona, April 13-17, 2016. Abstract LPB510.