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Simplified treatment monitoring may be effective for certain HCV cases

Researchers discovered potential for a simplified monitoring schedule compared with standard monitoring among certain patients treated direct-acting antivirals for chronic hepatitis C, according to data published in Journal of Hepatology.

“Although the comparison of simplified to standard treatment monitoring did not achieve non-inferiority, we believe that simplified monitoring can be recommended for many patients with chronic HCV, following careful individualized clinical assessment, including adherence support needs,” Gregory J. Dore, PhD, from the Kirby Institute in Sydney, Australia, and colleagues wrote. “Progress toward achieving the WHO HCV elimination 2030 goals should be enhanced through greater simplification of DAA treatment and monitoring.”

The researchers randomly assigned 380 patients to receive Mavyret (glecaprevir/pibrentasvir, AbbVie) with a standard (n = 127) or simplified monitoring schedule (n = 253). In the standard group, clinic visits occurred at baseline, week 4, week 8, and post-treatment week 12, compared with only a baseline and post-treatment visit for the simplified group. Patients who required treatment adherence support, such as injection drug users, were not eligible for the study.

All standard group patients completed treatment, whereas four patients in the simplified arm did not complete treatment including two discontinuations within 1 week and two who were lost to follow-up.

Intention-to-treat sustained virologic response was 97% in the simplified group and 98% in the standard group. According to Dore and colleagues, the lower SVR in the simplified arm did not relate to virological failure and the higher proportion of non-virological failure in the simplified arm compared with standard (5.5% vs. 3.1%) was due to the difference in efficacy including early treatment discontinuations.

“These findings suggest that for many patients, particularly those without cirrhosis or adherence concerns, a simplified treatment monitoring schedule may be appropriate,” they wrote. “Equally, the findings highlight the need for careful selection of patients for simplified treatment monitoring and the need to optimize post-treatment follow-up.”

The researchers noted that most of the patients lost to follow-up had reported high adherence during treatment and may have attained SVR. Additionally, they found no baseline factors correlated with loss to follow-up. – by Talitha Bennett

Disclosures: The authors report no relevant financial disclosures.