Reuters Health Information (2010-02-17): PEG-IFN/ribavirin: more adverse effects, worse adherence in older HCV-1 patients
PEG-IFN/ribavirin: more adverse effects, worse adherence in older HCV-1 patients
Last Updated: 2010-02-17 9:00:02 -0400 (Reuters Health)
NEW YORK (Reuters Health) - Older patients with chronic hepatitis C virus (HCV) infection -- especially those with HCV genotype 1 -- have poorer response to treatment, more adverse events, and poorer adherence.
The current standard of care for HCV is pegylated interferon (PEG-IFN) plus ribavirin, given for 48 weeks in patients with HCV-1 and for 24 weeks in those with genotypes 2 or 3.
In a prospective study, Dr. Ming-Lung Yu, of Kaohsiung Medical University Hospital, Taiwan, and colleagues compared the safety and efficacy of PEG-IFN in 70 older patients (>65 years) and in 140 sex- and genotype-matched middle-aged patients (ages 50 to 64).
In the March issue of the Journal of Infectious Diseases, the researchers report that the rate of treatment discontinuation was significantly higher in the older group (21% versus 6%; p = 0.001). The older patients also had a significantly higher rate of grade 3 or 4 adverse events (34% versus 20%; p = 0.024).
On intent-to-treat analysis, the older group had a markedly lower rate of sustained virologic response (67.1% versus 78.6%; p = 0.07), the poor responders more likely to be genotype 1.
If at least 80% of the recommended course was completed, however, rates of sustained virologic response were similar regardless of age (80.4% in the older group, and 82.6% in the middle-aged group).
Also, when older patients had a rapid virologic response, genotype did not affect the likelihood that the response would be sustained. (Rapid response was defined as the absence of HCV RNA on polymerase chain reaction tests at week 4.)
"Old-aged HCV-infected patients, especially those with a rapid viral response, could be effectively treated given that patients are carefully monitored during therapy," Dr. Yu noted in comments to Reuters Health.
In a study that appeared in Hepatology in 2008, Dr. Yu's group showed that in adults up to age 65, a 24-week regimen is as effective as the standard 48-week regimen for genotype 1 patients with lower baseline viral loads and a viral response by week 4 of treatment.
Next, Dr. Yu said, the plan is to enroll a third arm of elderly patients with rapid viral response and low baseline viral loads and treat them with a 24-week regimen, so that "the issue of efficacy and safety in old-aged patients with abbreviated regimens would be further explored."
Indeed, Dr. Yu and colleagues conclude, the greater frequency of adverse events in the 48-week regimen, and the poor adherence, "may be the major reason for treatment inferiority."
J Infect Dis 2010.