- Category: HCV Treatment
- Published on Tuesday, 15 October 2013 00:00
- Written by Liz Highleyman
Interferon-based therapy with telaprevir (Incivek or Incivo) produced a similar cure rate with no notable increase in side effects or treatment discontinuation for genotype 1 chronic hepatitis C patients over age 60, Japanese researchers reported at the second IDWeek conference held recently in San Francisco.
The advent of direct-acting antiviral agents has brought about a new era of hepatitis C treatment. While these new drugs will eventually be used in all-oral regimens, they will first be used as add-ons to pegylated interferon plus ribavirin. Triple therapy increases response rates and can shorten therapy, but the first-generation hepatitis C virus (HCV) protease inhibitors can also worsen side effects.
Norihiro Furusyo and colleagues from Kyushu University Hospital in Fukuoka conducted a prospective multicenter study to evaluate the safety and efficacy of triple therapy with telaprevir for older patients with chronic hepatitis C.
The researchers previously reported that older people treated with pegylated interferon plus ribavirin alone had significantly lower virological response rates and greater likelihood of premature treatment discontinuation due to adverse events compared with younger patients. Here, they aimed to determine whether this is also the case for interferon-based triple therapy. Telaprevir studies to date have not shown a correlation between age and the virological outcomes, they noted as background.
This prospective cohort study included 403 genotype 1 chronic hepatitis C patients treated at 22 centers. The present analysis was restricted to 120 patients who reached 24 weeks of post-treatment follow-up and could be evaluated for sustained virological response (SVR), or continued undetectable HCV 24 weeks after completing therapy.
Participants were categorized into 2 groups: 56 patients were age 60 years or younger (mean age 53 years) while 64 were over age 60 (mean age 66 years). Nearly two-thirds of the younger group but only one-third of the older group were men. Baseline HCV viral load and alanine and aspartate aminotransferase (ALT and AST) levels were similar in both groups, but the older patients had lower hemoglobin and platelet levels and poorer kidney function.
Among the younger patients, two-thirds had absent-to-moderate liver fibrosis (stage F0-F2) while one-third had advanced fibrosis or cirrhosis (F3-F4). In the older group, patients were evenly distributed between stage F0-F2 and F3-F4. Two-thirds of younger patients and 73% in the older group had a favorable IL28B gene variant associated with interferon responsiveness.
In the younger group 27% were treatment-naive, as were 19% in the older group; 52% and 55%, respectively, relapsed after prior interferon-based therapy, and 20% and 22%, respectively, were prior non-responders.
Participants were treated with 2250 mg/day telaprevir plus 60-150 mcg/week pegylated interferon-alfa 2b (PegIntron) and 600-1000 mg/day weight-based ribavirin for 12 weeks, followed by pegylated interferon/ribavirin alone for 12 additional weeks.
- Rapid virological response (RVR) rates, or undetectable HCV RNA at week 4, were 73% in both age groups.
- End-of-treatment response rates were 88% in the older group and 89% in the younger group.
- SVR rates at 24 weeks post-treatment were 77% and 84%, respectively, not a significant difference.
- Relapse rates were 13% and 6%, which also did not reach statistical significance.
- In both groups, people with the favorable IL28B pattern had significantly higher response rates than those with unfavorable variants.
- In a multivariate analysis, favorable IL28B pattern and RVR at week 4 were independent predictors of SVR.
- Treatment changes and discontinuations were common, with just 23% of older patients and 43% of younger patients completing the full course of treatment with at least 80% of intended interferon and ribavirin doses.
- 13% of participants in both age groups discontinued treatment early.
"Telaprevir-based triple therapy can be used successfully and safely to treat elderly patients with genotype 1 chronic hepatitis C," the researchers concluded. "IL28B genotyping and early virological response indicate effectiveness in these difficult-to-treat elderly patients."
N Furusyo, EOgawa, M Murata, et al. Telaprevir-based triple therapy for elderly patients with genotype 1 chronic hepatitis C. 2nd IDWeek Conference (IDWeek 2013). San Francisco. October 2-6, 2013. Abstract 462.