This article is more than 5 years old. Information may no longer be current.
Direct-acting antiviral therapy led to high SVR rates in patients with HCV genotype 1b
PHILADELPHIA — Patients with hepatitis C virus infection genotype 1b achieved sustained virologic response after 12 weeks of therapy with a regimen of three direct-acting antivirals, with and without ribavirin, according to data presented at the ACG Annual Scientific Meeting.
“In treatment naive and treatment experienced genotype 1b patients without cirrhosis the 3D regimen with or without ribavirin achieves optimal treatment efficacy regardless of prior treatment response,” Andreas Maieron, MD, of Elizabeth Hospital, Austria, said during the presentation.
Patients with HCV genotype 1b without cirrhosis from the PEARL-II and PEARL-III clinical trials (n=599) were randomized to receive a regimen of three direct-acting antivirals (3D); ABT-450/ritonavir/ombitasvir (150 mg/100 mg/25 mg) once a day and dasabuvir at 250 mg twice a day, with or without ribavirin. Overall, 298 patients received 3D with ribavirin and 301 received just a 3D regimen. Patients from the PEARL-II trial were treatment experienced and patients from the PEARL-III were treatment naive.
A sustained virologic response at 12 weeks (SVR12) was reached by 100% of patients from both clinical trials (n=301) who received 3D without ribavirin and 99% of patients who received 3D with ribvirin (n=295).
Adverse events were observed in 240 patients in the 3D with ribavirin group and 215 in the 3D group. Two patients from the 3D with ribavirin group discontinued treatment due to an adverse event and one experienced virologic failure; these three patients did not achieve SVR12.
“No patient discontinued treatment due to laboratory abnormalities,” Maieron said. “Both treatment regimens were well-tolerated.”
SVR12 among patients in both groups were not impacted by differences in age, race, HCV RNA viral load, fibrosis stage, IL28B genotype, sex, BMI and ethnicity.
For more information:
Maieron A. Abstract 4. Presented at: Annual ACG Scientific Meeting, Oct. 20-22, 2014; Philadelphia, PA.
Disclosure: See the abstract for a full list of relevant financial disclosures.
Perspective
Back to Top
This is an incredibly important study that is being presented. This is looking at patients who have hepatitis C genotype 1b, which is a very common genotype, being treated with a new combination of oral medications. They’re testing a combination of medications vs. this combination of medications plus ribavirin, which has been used in a lot of prior trials.
What’s incredible about this study is that in both arms of this trial — both with medications and with the medication plus ribavirin — there was a 99% response rate, which means that there was no evidence of the virus 12 weeks after the treatment ended. This was a quite well tolerated regimen, both arms were well tolerated.
This shows the potential for relatively short treatment courses of 12 weeks of an oral regimen that’s well tolerated that will essentially eradicate all hepatitis C. This is a huge breakthrough in our improvements in our management of patients with hepatitis C. And, of course, if we can eradicate hepatitis C, we can prevent the complications of hepatitis C, including cirrhosis, and the complications of cirrhosis, including GI bleeding, ascites, encephalopathy and the need for liver transplant.
I’m really excited about this oral presentation and I think it’s ground breaking research.