Abstract # 198: Adherence to Pangenotypic Glecaprevir/Pibrentasvir Treatment and SVR12 in HCV-infected Patients: An Integrated Analysis of the Phase 2/3 Clinical Trial Program—A. Brown, at al.
The study included 2,091 patients in phase 2 and 3 clinical trials of Abbvie’s glecaprevir plus pibrentasvir (Mavyret) to treat hepatitis C (HCV) genotypes 1 through 6. The treatment periods were 8, 12 and 16 weeks. The overall cure rates among all patients in phase 2 and 3 studies were greater than or equal to 95%. The adherence rates were analyzed to understand how adherence affected cure rates.
Conclusion: People who were 80% adherent were just as likely to achieve a cure as those who were 100% adherent. Those who were as low as 50% adherent had about a 90% chance of a cure. The factors of non-adherence included alcohol or tobacco use, the presence of compensated cirrhosis, severe kidney impairment, or genotype 3.
Editorial Comments: As a patient, taking all the medications is the most critical strategy for being cured. However, taking every pill, every day can be a challenge. If someone misses a dose, they should contact their medical provider for information about how and when to take their next dose.
There is also a real possibility that missing too many doses could mean that treatment will not work or that someone could develop drug resistance. However, as this study points out missing a dose does not mean that treatment will not work. This study should be very reassuring.
Alan Franciscus is the Executive Director of the Hepatitis C Support Project and the Editor-in-Chief of the HCV Advocate Website.To read the entire newsletter, click here
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Drug Pipeline and Conference Coverage
July and August are very important months in hepatitis C treatment for patients. On July 18, 2017, the Food and Drug Administration (FDA) approved Gilead’s sofosbuvir/velpatasvir/voxilaprevir—brand name Vosevi–to re-treat adults with hepatitis C. In August 2017 the FDA is expected to approve AbbVie’s glecaprevir/pibrentasvir—brand name Maviret. The July and August approvals will push hepatitis C cure rates up to nearly 100%!
Gilead’s three drug combination is a pan-genotypic HCV medication co-formulated into one pill, taken once-a-day. The FDA stipulates that Vosevi is approved to treat people who have previously been treated with a DAA but who did not achieve a cure. The treatment period is 12 weeks is considered a salvage therapy—a term used for people who have failed another DAA therapy.
For the people who were treated prior with DAAs but who did not achieve a cure, 12 weeks of treatment cured up to 100% of patients.
The most common side effects were a headache, fatigue, diarrhea, and nausea.
This is very good news for the 5% to 10% of people who have failed prior DAA therapy who had few treatment options until now.
Be sure to check out our Hep C Medications Blog for more detailed information about Vosevi and the other HCV medications approved to treat hepatitis C.
Update: Since the newsletter was published Mavyret has been approved by the FDA.
AbbVie’s two drug combination is also a pan-genotypic (genotypes 1 through 6) co-formulated into one pill, once-a-day treatment for people with hepatitis C and compensated cirrhosis. The treatment period is 8 weeks and cure rates in the clinical trials were 95% to 99%.
The most common side effects were fatigue and headache.