Telaprevir, boceprevir offer similar efficacy for most patients with HCV 1

Telaprevir, boceprevir offer similar efficacy for most patients with HCV 1

Source

Last Updated: 2012-10-25 15:05:17 -0400 (Reuters Health)

By Will Boggs, MD

NEW YORK (Reuters Health) - For most patients with hepatitis C virus (HCV) 1, telaprevir and boceprevir offer similar efficacy, researchers say.

"Based on our findings, I would feel that for the majority of patients there is no difference in efficacy between the two agents and the choice should come down to patient and physician preference with perhaps some consideration being given to cost if there are no pressing clinical reasons why one would choose a particular agent over another," Dr. Jennifer A. Kiernan from St. James Hospital, Dublin, Ireland, told Reuters Health.

She added, "For patients who have experienced a previous treatment relapse, our research would suggest that telaprevir would be a better choice."

As there are no head-to-head comparison trials so far, Dr. Kiernan and colleagues used a Bayesian mixed treatment comparison model to explore the relative differences in efficacy between boceprevir and telaprevir when used as a third agent (with pegylated interferon and ribavirin) in HCV genotype 1 treatment.

Their review online October 16 in Clinical Infectious Diseases included six studies related to treatment-naïve patients and four studies related to treatment-experienced patients.

Among treatment-naïve patients, adding boceprevir or telaprevir to the backbone therapy of interferon and ribavirin significantly improved efficacy, and there was insufficient evidence to detect a difference between the two drugs.

Results were similar in pretreated patients, but in the subset of patients who had a prior treatment relapse (n=841) there was a significant difference in efficacy favoring telaprevir.

Relapse rates did not differ between telaprevir and boceprevir for treatment-naïve patients, but among patients with prior treatment, those treated with telaprevir had a lower relative rate of relapse compared with boceprevir treatment (although this difference fell just short of statistical significance).

"The optimum approach to this question would be a randomized controlled non-inferiority head-to-head trial," Dr. Kiernan said. "However, there are none planned. Therefore, this analysis provides useful estimates of relative efficacy."

"In Ireland, we are in the process of developing a national treatment outcomes registry to study the treatment outcomes of patients commenced on HCV protease inhibitor therapy," Dr. Kiernan added. "We hope that this will provide additional effectiveness data on how these agents perform in a real-world clinic-based environment."

SOURCE: The Relative Efficacy of Boceprevir and Telaprevir in the Treatment of HCV Genotype 1

Clin Infect Dis 2012.

 

The Relative Efficacy of Boceprevir and Telaprevir in the Treatment of HCV Genotype 1
,

1. Susanne Schmitz1,
2. Aisling O’Leary2,
3. Cathal Walsh3,
4. Colm Bergin4, and
5. Suzanne Norris5

+ Author Affiliations

1. ¹Department of Statistics, Trinity College Dublin, Ireland
2. ²National Centre for Pharmacoeconomics, Dublin 8, Ireland
3. ³Department of Statistics, Trinity College Dublin, Ireland
4. ⁴Department of Genito-urinary Medicine and Infectious Diseases, St James Hospital, Dublin, Ireland
5. ⁵Department of Hepatology, St James Hospital, Dublin 8, Ireland

1. Corresponding Author: Dr Jennifer A. Kieran Address: Department of Pharmacology and Therapeutics, Trinity Centre for Health Sciences, St James Hospital, Dublin 8, Ireland Tel no: +353 1 8962667 Fax no: +353 1 4539033 Email: kieranja@tcd.ie

1. Alternate Corresponding Author: Prof. Michael G. Barry, Address: Department of Pharmacology and Therapeutics, Trinity Centre for Health Sciences, St James Hospital, Dublin 8, Ireland. Tel. No: +353 1 8961563 Fax no: +353 1 4539033 Email: mbarry@stjames.ie

 

Abstract

Background. The licensing of direct-acting anti-virals heralds a new era in the treatment of HCV genotype 1. There are no head-to-head trials examining their comparative efficacy and there are none currently registered. We undertook a mixed treatment comparison to examine the relative efficacy among current treatments for HCV.

                

Methods. A systematic literature review identified relevant studies. Meta-analyses were planned in treatment-naïve and treatment-experienced patients. Study arms which evaluated telaprevir or boceprevir for unlicensed durations or without both pegylated-interferon and ribavirin at standard doses were excluded. A Bayesian mixed treatment comparison model was fitted for each patient population. Potential influence of confounders was analysed using meta-regression.

                

Results. 499 studies were identified, 10 studies met inclusion criteria. In the subgroup of prior treatment “relapsers” telaprevir had greater relative efficacy than boceprevir (Odds Ratio 2.61(1.24, 5.52)). There were no statistically significant differences detected in relative efficacy for other patient categories. Treatment-naïve patients: boceprevir versus standard-of-care (n= 1417) Odds Ratio 3.06(2.43, 3.87); telaprevir versus standard-of-care (n=1309) Odds Ratio 3.24(2.56, 4.10); telaprevir versus boceprevir Odds Ratio 1.06(0.75, 1.47). Total treatment-experienced population: boceprevir versus standard-of-care (n=604) Odds Ratio 6.53(4.20, 10.32); telaprevir versus standard-of-care (n=891) Odds Ratio 8.32(5.69, 12.36); telaprevir versus boceprevir Odds Ratio 1.27(0.71, 2.30).

                

Conclusions. Telaprevir had greater relative efficacy than boceprevir in patients who had previously relapsed. There was insufficient evidence to detect a difference in treatment outcomes between the two agents in the overall population. It was not possible to determine relative efficacy for subgroups such as cirrhotics due to small numbers.