It may be possible for some people undergoing hepatitis C virus (HCV) treatment to attend clinic visits just twice as opposed to every four weeks as is standard.
Presenting their findings at the 53rd International Liver Congress in Vienna, researchers conducted a randomized controlled study called SMART-C of 380 people with HCV whom the investigators considered not to be at risk for poor adherence to a drug regimen. For example, those who reported recent injection drug use were excluded. The participants were all first-timers to treatment who did not have cirrhosis.
The participants were randomized two to one to receive eight weeks of Mavyret (glecaprevir/pibrentasvir) treatment to follow a simplified monitoring schedule (253 people) or the standard monitoring schedule. The standard monitoring group made clinic visits upon starting treatment and at weeks four and eight, followed by a visit 12 weeks after completing treatment. Those in the simplified monitoring group did not have to make the visits at weeks four and eight but received a phone call from a nurse at those two time points.
Sixty percent of the participants were male, 48 percent had genotype 1 of HCV, 32 percent had genotype 3, 7 percent were coinfected with HIV and 10 percent were on medication-assisted treatment for opioid use disorder.
Ninety-two percent of those in the simplified monitoring group achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure), compared with 95 percent of those in the standard monitoring group. The difference between these two cure rates was not statistically significant, meaning that it could have been driven by chance.
However, the study authors found they could not deem the simplified monitoring system noninferior to, or as effective as, the standard system because the statistical estimate range for how the actual respective cure rates may differ in the real world had a disparity greater than 6 percentage points between them. Prior to conducting the study, the researchers had established a this level of disparity between the estimate ranges as the threshold for determining noninferiority.
That said, when they looked at the cure rates among the participants who had completed treatment, the investigators found that 97 percent of those in the simplified monitoring group were cured compared with 98 percent of those in the standard monitoring group.
The study authors concluded that eight week of Mavyret was safe and effective on a simplified monitoring schedule for those not assessed to be at risk of poor adherence to the drug regimen.