Harvoni Shows Promise Treating Hepatitis C in Adolescents
Overall positive results shown in studies with Harvoni and sofosbuvir/velpatasvir.
Gilead recently announced results from phase 2 and phase 3 studies investigating fixed-dose combination therapies for chronic hepatitis C virus (HCV), as well as new data about Harvoni use in adolescents.
All findings were presented at the International Liver Congress 2016.
“The data presented this week continue to underscore the high cure rates and safety of our sofosbuvir-based HCV therapies, and support their utility across all patient HCV genotypes and disease stages,” said Norbert Bischofberger, PhD, executive vice president of Research and Development and Chief Scientific Officer at Gilead. “We are pleased to have the opportunity to further characterize the pangenotypic profiles of our two new investigational fixed-dose combinations, sofosbuvir/velpatasvir and sofosbuvir/velpatasvir plus GS-9857, and to highlight results from the first study to evaluate interferon-free HCV therapy in adolescents.”
In the phase 3 ASTRAL-5 study (PS104), researchers evaluated once-daily SOF/VEL for 12 weeks. The study enrolled patients with HCV genotypes 1 through 6 with an HIV coinfection.
Researchers found a high sustained viral response (SVR) rate in these patients.
There was a 95% SVR12 in patients with cirrhosis and 97% SVR12 in patients who experienced prior treatment failure.
The most common side effects noted were fatigue and headache.
Sofosbuvir/Velpatasvir (SOF/VEL) Plus GS-9857
Study 1168 evaluated 197 genotype 1 patients, while Study 1169 included 128 HCV genotypes 2-6 patients.
All treatment naïve patients received 6 to 8 weeks of treatment with SOF/VEL plus GS-9857 with or without ribavirin (RBV).
All patients who failed prior treatment received 12 weeks of SOF/VEL plus GS-9857.
Treatment naïve patients treated with SOF/VEL plus GS-9857 had a 79% SVR12 at 6 weeks and 96% SVR12 at 8 weeks.
Treatment experienced patients had an overall SVR rate of 99%.
This study was conducted among genotype 1, DAA-experienced, HCV-infected patients. They received 12 weeks of SOF/VEL/GS-9857 with or without RBV.
Patients receiving SOF/VEL/GS-9857 showed a 100% SVR 12 rate, and 96% of patients receiving SOF/VEL/GS-9857 plus RBV achieved SVR12.
Currently, a fixed-dose combination of SOF/VEL/GS-9857 is being tested in 4 phase 3 studies. The treatment was granted Breakthrough Therapy designation by the FDA for the treatment of chronic genotype 1 HCV patients.
This study evaluated the drug in adolescent patients with genotype 1 HCV between 12 and 17 years of age.
Of 100 patients enrolled in this study,97% achieved SVR12. No patients experienced virologic failure.
Some patients experienced headache, diarrhea, and fatigue.
Researchers state that further studies looking into the use of Harvoni in the pediatric population are ongoing.