日前,Tibotec公司的Incivo(telaprevir)与聚乙二醇干扰素α、和利巴韦林的联合获得欧盟批准,用于治疗成年人患有的agenotype-1慢性丙型肝炎(HCV)。
在之前的研究中,包括之前对未经过治疗的和治疗失败的agenotype-1慢性丙型肝炎患者的研究,与用聚乙二醇干扰素α;和利巴韦林进行的标准治疗相比,Incivo (telaprevir)与聚乙二醇干扰素α、和利巴韦林的联合使得治愈率有较大进展。
欧盟的这项决定主要基于三期研究的结果,主要是研究Incivo (telaprevir)与聚乙二醇干扰素α和利巴韦林联合使用的效用及安全性。
这些试验的结果表明,与Incivo (telaprevir)与聚乙二醇干扰素α和利巴韦林的联合治疗能提高治愈率相比,用聚乙二醇干扰素α和利巴韦林进行的标准(疗法治疗未经治疗的患者却能使病情复发。
New Drugs Online Report for telaprevir
Information
Generic Name: telaprevir
Trade Name: Incivo (EU), Incivek (US)
Entry Type: Licence extension / variation
Development and Regulatory status
UK: Unknown
EU: Unknown
US: Unknown
UK launch Plans: Available only to registered users
Actual UK launch date:
Comments
Aug 14: Vertex is stopping distribution of telaprevir in the US by mid Oct, because of falling sales. Development and distribution plans in the EU not currently known [6].
28/08/2014 16:02:47
Nov 11: Open-label PIII study starts [3].
09/11/2011 09:32:23
Mar 11: PIII study planned for later in 2011 [1].
03/03/2011 22:10:44
Trial or other data
Mar 14: no further update
24/03/2014 16:49:20
May 13: PII (NCT00983853) study published. Sustained virologic response occurred in 74% (28 in 38) of patients receiving TVR plus PEG-IFN-α2a–ribavirin and 45% (10 in 22) of patients receiving placebo plus PEG-IFN-α2a–ribavirin. Rapid HCV suppression was seen with TVR plus PEG-IFN-α2a–ribavirin (68% [26 in 38 patients] vs. 0% [0 in 22 patients] undetectable HCV RNA levels by week 4). Two patients had on-treatment HCV breakthrough with TVR-resistant variants. Patients treated with antiretroviral drugs had no HIV breakthroughs; antiretroviral exposure was not substantially modified by TVR [5].
22/05/2013 08:54:39
Dec 11: NCT01500616 a PIII multicentre, open-label, study of telaprevir (750 or 1125mg every 8 hours for 12 weeks) in combination with peginterferon alfa and ribavirin (for 48 weeks) in 1,000 HIV/genotype 1 chronic hepatitis c coinfected subjects with severe fibrosis or compensated cirrhosis. The primary outcome is adverse events. The study started in Dec 11 and is due to complete Mar 15 [4].
03/01/2012 17:12:46
Nov 11: NCT01467479 an open label, PIII study of telaprevir in combination with peginterferon alfa 2a (Pegasys®) and ribavirin (Copegus®) in 160 subjects coinfected with genotype 1 HCV and HIV-1. The primary outcome is the proportion of patients who achieve undetectable HCV RNA 12 weeks after the last planned dose of study drug (SVR12). Telapavir will be given in doses of 1125 mg 2 or 3 times daily (with efavirenz based regimens) for 12 weeks; ribavirin and peginterferon will be given for 24 or 48 weeks. Patients included in the study include those who are treatment naïve, and treatment experienced patients who have responded and relapsed or were null or partial responders. The study started Nov 11 and is due to complete Jun 15 [3].
03/01/2012 17:12:27
Nov 11: Interim week 24 data from ongoing PII study: 74% (28/38) of pts treated with telaprevir had undetectable hepatitis C virus (HCV RNA) at Week 24 of treatment vs. 55% (12/22) who were treated with pegylated-interferon and ribavirin alone. Changes in CD4 counts were similar between the treatment groups and no HIV viral load breakthroughs were observed in either treatment group during the study. Adverse events that occurred more frequently (≥10% difference) in the telaprevir arms vs. placebo were: abdominal pain, vomiting, nausea, fever, dizziness, depression and itchiness. No severe rashes were reported through 24 weeks. Interim data also showed 63% (24/38) of patients treated with telaprevir combination therapy had an extended rapid hepatitis C viral response (eRVR, measured as undetectable HCV RNA at weeks four and 12 of treatment) vs. about 5% (1/22) who received pegylated-interferon and ribavirin alone. [2]
07/11/2011 16:56:28
Mar 11: Interim results reported from an ongoing, two-part (A and B), PII study eva luating 12 weeks of telaprevir plus pegylated-interferon and ribavirin (PEGI+R) followed by a further 36 weeks of PEGI+R vs PEGI+R alone in 60 people with HIV infected with genotype 1 hepatitis C virus (HCV), naive to HCV treatment. Part A (n=13) is in people who are not currently being treated with antiretroviral therapy (ART) for HIV infection. Part B (n=47) is eva luating telaprevir in people receiving Atripla® or a Reyataz®-based regimen for HIV. The interim analysis was conducted when all patients had reached week 4 of treatment. At that time, 70% vs 5% of people in the study had undetectable HCV (rapid viral response, RVR). Adverse events that occurred more frequently (≥10% difference) in the telaprevir arm vs placebo were pruritus, nausea, dizziness, pyrexia, anorexia and vomiting. The majority of adverse events were mild or moderate [1].
03/03/2011 22:12:26
References
Available only to registered users
Category
BNF Category: Antiviral drugs (05.03)
Pharmacology: Hepatitis C virus NS3 and NS4 protein inhibitor
Epidemiology: Up to 30% of people with HIV/AIDS are also infected with hepatitis C [1].
Indication: Co-infection with HCV and HIV
Method(s) of Administration
Oral
Company Information
Name: Tibotec Pharmaceuticals
US Name: Vertex
Further Information
Anticipated commissioning route (England) NHSE
High cost drug list? Awaiting Update
Implications Available only to registered users |
