Janssen Infectious Diseases-Diagnostics BVBA (Janssen), announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the approval of twice daily (BID) dosing of INCIVO(R) (telaprevir), a direct acting antiviral (DAA) for the treatment of chronic genotype-1 hepatitis C virus (HCV), in combination with pegylated-interferon and ribavirin (PR).
The CHMP positive opinion is a critical step in the approval process and will be considered by the European Commission, which has authority to approve medicines for use throughout the European Union. The current approved dose for INCIVO is 750 mg every 8 hours in combination with PR.
"This positive opinion from the CHMP is an important development for a more convenient treatment regimen for patients which should help lead to greater adherence, a critical factor in HCV treatment," said Gaston Picchio, Hepatitis Disease Area Leader at Janssen R&D. "Telaprevir has already played a huge part in improving treatment outcomes for people living with hepatitis C with more than 80,000 people treated to date globally with telaprevir combination treatment. This recommendation is the next step in our commitment to improving the lives of more people living with hepatitis C and supporting healthcare professionals around the world."
Janssen presented clinical trial results showing that the relative efficacy of a twice daily (BID) investigational dosing regimen of INCIVO(R) (telaprevir) 1125 mg combination treatment was similar to an every eight hours (q8h) regimen of INCIVO(R) (telaprevir) 750 mg combination treatment in HCV genotype-1 patients regardless of fibrosis or cirrhosis based on sustained virological response rates at 12 weeks after the last treatment dose (SVR12).[1] These results, a sub-analysis from the OPTIMIZE Phase 3 trial, were presented during the 48th annual meeting of the European Association for the Study of the Liver (EASL) in Amsterdam (http://www.easl.eu/_the-international-liver-congress [http://www.easl.eu/_the-international-liver-congress/general-information ]). Additional sub-analyses from this study evaluating anemia management,[2] efficacy in patients by the IL28B genotype[3] and patient adherence[4] were also presented.
"Simplifying available treatment regimens for HCV, without compromising on cure rates is especially important for patients with fibrosis or cirrhosis. We know that telaprevir combination treatment offers patients improved cure rates over treatment with pegylated interferon and ribavirin alone. These results confirm that a twice daily dosing schedule for a telaprevir-based regimen gives patients a similar chance of achieving SVR12 as the current approved dose in a population who desperately need more effective treatment," said Yves Horsmans, Lead Study Investigator and Professor at Cliniques Universitaires Saint-Luc, Belgium.
Results from the sub-analysis of the 740 patients included in the OPTIMIZE study showed that those with cirrhosis who received a twice daily dose of telaprevir 1125 mg in combination with PR, achieved similar SVR12 rates compared with those who received telaprevir 750 mg every 8 hours in combination with PR (54% versus 49%).[1] Patients at other stages of fibrosis, F0 to F4, also achieved similar SVR12 rates with a twice daily dose of telaprevir 1125 mg in combination with PR compared with those who received telaprevir 750 mg every 8 hours in combination with PR (see table 1).
Table 1: SVR 12 rates, HCV RNA<25 12="" after="" br="" dose="" iu="" last="" ml="" of="" planned="" pr="" weeks="">
Fibrosis
Telaprevir F0-2 F3-4 Cirrhosis w/o Cirrhosis
dosing n=529 n=210 n=103 n=636
Telaprevir 1125 mg 80% 60% 54% 78%
twice daily + PR (213/267) (61/102) (29/54) (245/315)
Telaprevir 750 mg 79% 57% 49% 77%
every 8 hours + PR (208/262) (62/108) (24/49) (246/321)
The safety and tolerability of telaprevir across fibrosis or cirrhosis stages were consistent with previous studies.[1] Grade 3 or 4 adverse events (AEs) were reported in 41% of patients with and 40% of patients without cirrhosis.[1] Serious adverse events and discontinuations due to adverse events were higher in patients with cirrhosis than those without (14% and 21% versus 8% and 16%, respectively).[1] The most common adverse events experienced were fatigue, pruritus, anemia, nausea and rash.[5]The proportion of patients who experienced a low haemoglobin level (less than or equal to10g/dL) was higher among patients with (50%) than without cirrhosis (42%).[1]
Results from an additional sub-analysis of the OPTIMIZE study found that adherence was greater in patients who received twice daily dosing of telaprevir compared to every eight hours.[4] "Treating HCV can be complex and therefore anything that can help make effective treatments simpler and adherence easier for patients will ultimately improve their chance of achieving a cure," said study investigator Dr Maria Buti, Hospital Val d'Hebron, Spain.
Additional telaprevir data from the OPTIMIZE study presented at EASL includes*:
- Anemia and its management in patients treated with telaprevir twice
daily[2]
- Efficacy of telaprevir dosed twice daily versus every 8 hours by IL28B
genotype[3]
- Adherence with telaprevir BID vs q8h dosing in treatment-naïve HCV-infected
patients[4]
* Poster session: Friday,April 26 from 9:00 AM-6:00 PM
Additional telaprevir data presented at EASL includes*:
- Management and outcomes of anemia in the International Telaprevir Early
Access Program, for patients with hepatitis C genotype 1 infection[6]
- Treatment with telaprevir-based therapy after exposure to peg-IFN/RBV in the
REALIZE study[7]
- Treatment with telaprevir/peg-IFN/RBV after 14-day telaprevir exposure in
Phase I studies[8]
- High SVR rates (SVR4) for 12-week total telaprevir combination therapy in
IL28B CC treatment-naïves and prior relapsers with G1 chronic hepatitis C: CONCISE
interim analysis[9]
* Poster session: Friday,April 26 from 9:00 AM-6:00 PM
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