Reuters Health Information: In half of hepatitis C patients, DAA treatment can shortened to 6 weeks
In half of hepatitis C patients, DAA treatment can shortened to 6 weeks
Last Updated: 2018-11-23
By Lorraine L. Janeczko
NEW YORK (Reuters Health) - In about half of patients with hepatitis C virus (HCV) infection, response-guided therapy with oral direct-acting antiviral agents (DAAs) can be reduced from the standard 12 weeks to as little as six weeks and still be effective, according to a new pilot study.
DAAs have revolutionized hepatitis C treatment, eliminating the virus and enabling a cure with minimal side effects in over 90% of patients treated. But the high cost, which can exceed $50,000 per patient, limits patient access and burdens the insurance industry, researchers write in a press release.
"Implementing response-guided therapy as standard of care may lead to significant cost savings on the expensive hepatitis C treatment," senior author Dr. Amir Shlomai of Beilinson Hospital in Petah-Tikva, Israel, told Reuters Health by email.
The team enrolled 22 HCV patients with compensated liver disease and genotypes 1 to 6, who were either treatment naive or interferon experienced. Participants were treated with one of four DAA regimens chosen by the investigators.
Viral load was measured at baseline, at day 2, and at weeks 1, 2, and 4 after the start of treatment. The primary endpoint was the proportion of patients with sustained virologic response at 12 weeks (SVR12) post-treatment, with undetectable HCV RNA (<15 IU/mL).
The researchers presented the preliminary proof-of-concept results in a late-breaking abstract poster session on November 12 at The Liver Meeting 2018, the annual meeting of the American Association for the Study of Liver Diseases (AASLD), in San Francisco.
Participants averaged roughly 50 years of age, 11 were female and 9% had METAVIR scores of F3-4. The most common genotypes were G1b (59%) G3 (27%), G1a (9%), and G2 (5%).
The drug combinations sofosbuvir/velpatasvir, elbasvir/grazoprevir, sofosbuvir/ledipasvir and glecaprevir/pibrentasvir were administered to 41%, 31%, 23% and 5% of participants, respectively.
Mathematical modeling of viral kinetics was performed during weeks 2-4 to project time to cure, and model projections were used to individualize each participant's treatment duration.
Modeling predicted that treatment duration could be shortened to 10 weeks in one patient (5%), eight weeks in eight (36%) and six weeks in two (9%).
Of the 19 participants who completed therapy, 100% had undetectable viral load at the end of treatment. Of those, 18 (95%) remained HCV-undetectable four weeks after treatment.
Of the 15 patients who reached post-treatment week 12, 14 (93%) achieved SVR12.
One treatment-naive G3 patient with F1 fibrosis who was treated with sofosbuvir/velpatasvir for six weeks relapsed. Virus sequencing did not detect resistance-associated substitutions at baseline or in response to treatment, and no significant side effects were found among the DAA-treated patients.
"A shorter treatment may lead to improved compliance to treatment, especially in special populations, including hepatitis C patients with limited health insurance benefits," Dr. Harel Dahari of Loyola University Chicago in Maywood, Illinois, who also worked on the study, told Reuters health by email.
Dr. Dahari estimates that the shorter treatment may potentially decrease the cost of HCV drugs by up to 20%.
Now that the proof-of-concept pilot study has shown that response-guided therapy can potentially reduce treatment times, a large multicenter trial to validate the results is underway in Israel, the authors say.
Clalit Health Services in Israel and the United States National Institutes of Health helped support the study. The authors state that they have no conflicts of interest.
AASLD The Liver Meeting 2018.