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Telaprevir
Telaprevir is an oral protease inhibitor (PI) for the treatment of hepatitis C virus (HCV) infection. HCV protease is a unique HCV enzyme that plays a key role in viral replication and may also help the virus evade host immune defenses.
Protease inhibitors; Hepatitis C viruses use an essential enzyme called protease (pro-tee-aze) during their replication process. Certain drugs can interfere with this enzyme which stops the virus' ability to copy itself. ;
Polymerase inhibitors; Each time hepatitis C viruses replicate, they use an enzyme called polymerase to copy their RNA (genetic code). Polymerase inhibitors are drugs that interfere with polymerase.
April 2012
NICE has given its final recommendation for two new hepatitis C pills in an expedited review.
INCIVEK™ (telaprevir) Now Funded for People With Hepatitis C in Quebec and Saskatchewan
Telaprevir May Cause Severe Cutaneous Eruptions NEW YORK (Reuters Health)
Vertex Update-Plans enrollment for Phase 2b study all-oral (interferon-free) treatment regimen
EASL-INCIVO® (Telaprevir) SVR Rates Unaffected by Ribavirin Dose Reduction in Treatment Naïve and Previously Treated Patients With Genotype-1 Chronic HCV
Janssen Pharmaceutica NV (Janssen) will present new data for INCIVO (telaprevir) from Phase 3 retrospective sub-analyses at the 47th annual meeting of the European Association for the Study of the Liver (EASL) in Barcelona. The data shows that similar sustained virologic response (SVR) rates were achieved regardless of ribavirin dose reduction..........
Hepatitis C Viral Evolution in Genotype 1 Treatment-Naïve and Treatment-Experienced Patients Receiving Telaprevir-Based Therapy in Clinical Trials
To better understand the impact of protease inhibitor treatment on the dynamic nature of the HCV population, we analyzed viral sequences from individual patients enrolled in telaprevir clinical trials before treatment, to define the
baseline prevalence of resistant variants, and during treatment in patients who failed to achieve an SVR, to define the relationship between treatment failure and emergence of resistant variants. Further analyses were performed in patients
after treatment to evaluate the evolution of resistant variants in the absence of drug selective pressure. These analyses provided an understanding of factors involved in the selection of resistant variants in patients treated with
telaprevir, and have been important in optimizing telaprevir treatment regimens by increasing SVR rates and minimizing clinical resistance...........
High Cost of Telaprevir Overshadows Clinical Benefits in Patient Subset
The price of HCV therapy has risen since the introduction of direct-acting antiviral drugs (DAAs) to the market. For example, a 12-week course of telaprevir combined with 36 weeks of pegylated interferon (Peg-IFN) and ribavirin is estimated to cost $85,872, and a full 48-week course of boceprevir-based therapy costs about $71,873. In contrast, the previous standard
therapy without DAAs—48 weeks of Peg-IFN alfa and ribavirin—is approximately $36,672................
March 2012
NICE publishes final draft guidance on telaprevir for chronic hepatitis C
Healthcare guidance body NICE has today (16 March) issued final draft guidance recommending telaprevir (Incivo, Janssen Cilag), in combination with peginterferon alfa and ribavirin, as an option for the treatment of genotype 1 chronic hepatitis C in adults with compensated liver disease [1].
NCIVEK interim results:74% People Co-Infected with Hepatitis C/HIV Had Undetectable Hepatitis C Virus 12 Wks After TX Ended (SVR12)
Data showed 74 percent (28/38) of patients who were treated with INCIVEK (in-SEE-veck) combination therapy had undetectable hepatitis C virus (HCV RNA) 12 weeks after the end of all study treatment (SVR12) compared to 45 percent (10/22) who were treated with pegylated-interferon and ribavirin alone.
Feb 2012
Vertex Announces 12-Week On-Treatment Data and SVR4 From Phase 2 Study of Interferon-Free (All-Oral) Treatment Regimen of INCIVEK®, VX-222 and Ribavirin in People with Genotype 1 Hepatitis C
Jan 2012
All About; Incivek (Telaprevir)-An Oral Protease Inhibitor for Hepatitis C Virus Infection
Dec 2011
Incivek and Victrelis Usage as Part of Triple Therapy Hepatitis C Regimen is Emerging as the New Standard of Care for Genotype 1 Patients
Watch-The Coming of Age of Direct Anti-Viral Agents for HCV
Incivo-Telaprevir approved in Scotland
Scottish Medicines Consortium approves INCIVO® (telaprevir), a new treatment for genotype-1 chronic hepatitis C, for use within NHS Scotland1
Janssen Pharmaceutical
Posted on:23 Dec 11
Shortens the course of treatment for many (58%) treatment naive genotype-1 chronic hep C patients compared to current standard treatment2
High Wycombe, 12th December 2011 –
Today the Scottish Medicines Consortium (SMC) has recommended that INCIVO® (telaprevir)* should be made available for the treatment of genotype-1 chronic hepatitis C (hep C), in combination with peginterferon alfa and ribavirin (i.e. current standard treatment), in adults in Scotland who have not previously had treatment and adult patients for whom treatment has previously failed1.
Telaprevir, a new direct acting antiviral (DAA) protease inhibitor (PI), one of a new class of medicines which directly targets the Hep C virus, now offers significantly more patients infected with genotype 1 chronic hep C in Scotland the chance of clearing the virus (achieving sustained virologic response, SVR)2,3,4 compared to current standard treatment.
“I welcome the news that telaprevir can now be prescribed for patients living with chronic genotype-1 hep C in Scotland. Before the introduction of protease inhibitors, of which telaprevir is the latest, treatment for hep C required a long duration and less than 50% of chronic genotype-1 hep C patients got rid of the virus” said Dr John F Dillon, Consultant Hepatologist and Gastroenterologist, University of Dundee Ninewells Hospital. “For many adults with chronic genotype-1 hep C, treatment with a telaprevir based regimen could provide a shorter treatment duration with improved response rates compared to standard treatment.”
In Scotland, it is estimated that 50,000 individuals are infected with hep C5. Hep C is a significant public health threat. It is highly infectious, often has no symptoms and can lead to fatal liver conditions. Of those who develop hep C an estimated 30% will develop cirrhosis (deterioration of the liver), others will develop liver cancer, some of whom may require liver transplantation6. Hep C is the most common reason for liver transplants in Europe7. A model, developed in Scotland, which looks at transmission rates for hep C has shown that effective treatment of the disease, assuming a 62.5% SVR rate, could reduce the onward transmission of the virus and its occurrence in the community.
Taking this into account it could be expected that effective treatment of hep C with a treatment regimen that achieves a higher SVR rate will, in the longer term, reduce the risk of transmission among the population and lower the burden of hep C on NHS Scotland8. The standard treatment for hep C, peginterferon alfa and ribavirin, is successful in only about 50% of patients with genotype 1, leaving the other 50% without a successful treatment outcome6.
Clinical trials have shown that a telaprevir based regimen is significantly more effective than standard treatment in all genotype-1 patient types, including those with advanced liver disease such as cirrhosis.
The addition of telaprevir cleared the Hep C virus in almost twice as many previously untreated patients (79% vs. 46%, p<0.0001) and almost four times as many who had previously relapsed following treatment (84% vs. 22%, p<0.001)3,4,9. It also offers the potential to halve the current total treatment duration to just six months in many (58%) previously untreated patients and prior treatment relapsers2,3,9.
The marketing authorisation for telaprevir was based on results from three phase III clinical trials, ADVANCE, REALIZE and ILLUMINATE3,4,9 which evaluated the efficacy and safety of telaprevir in combination with peginterferon alfa and ribavirin in more than 2,290 treatment-naïve and previously-treated chronic genotype 1 hep C patients. Data from ADVANCE and REALIZE were published in the 23rd June 2011 edition of the New England Journal of Medicine (NEJM). Data from the ILLUMINATE study were published in the 15th September 2011 edition of the NEJM. This marked the sixth paper to be published on telaprevir in the NEJM10,11,12.
The overall safety and tolerability profile of telaprevir is based on the phase II and III clinical development programme. The most frequently reported moderate adverse reactions (incidence = 5.0%) were anaemia, rash, pruritus, nausea, and diarrhoea, and the most frequently reported severe adverse reactions (incidence = 1.0%) were anaemia, rash, thrombocytopenia, lymphopenia, pruritus, and nausea2.Rash events were reported in 55% of patients with telaprevir based treatment compared with 33% in the control arm (peginterferon alfa and ribavirin only). More than 90% of rashes were of mild or moderate severity. Severe rashes were reported with telaprevir based treatment in 4.8% of patients. Rash led to discontinuation in 5.8% of patients. Anaemia was reported in 32.1% of patients compared with 15% in the control arm (peginterferon alfa and ribavirin only). It led to discontinuation in approximately 3% of patients2.* INCIVO® (telaprevir), a direct acting antiviral protease inhibitor, was co-developed by Vertex Pharmaceuticals and Tibotec, an affiliate of Janssen Pharmaceutical Companies of Johnson & Johnson, and the company responsible for marketing telaprevir in Europe.
References
1.The Scottish Medicines Consortium (http://www.scottishmedicines.org.uk/Home), accessed December 20112.Telaprevir Summary of Product Characteristics 20113.Jacobson, Ira M. Telaprevir for Previously Untreated Hepatitis C Virus Infection. N Engl J Med. 2011; 364; 2405-16.4.Zeuzem, Stefan MD. Telaprevir for Retreatment of HCV Infection. N Engl J Med. 2011; 364; 2417-28.5.Hepatitis C Action Plan for Scotland Phase II May 2008-March 20116.TA200: Peginterferon Alfa and Ribavirin for the treatment of chronic hepatitis C. Part review of NICE technology appraisal guidance 75 and 106. Issued September 20107.Lang K, Weiner DB. Immunotherapy for HCV infection: next steps. Expert Rev Vaccines. 2008;7(7): 915-9238.Martin NK, Vickerman P, Foster GR, Hutchinson SJ, Goldberg DJ, Hickman M. Can antiviral therapy for hepatitis C reduce the prevalence of HCV among injecting drug user populations? A modeling analysis of its prevention utility. J Hepatol 2011 Jun;54(6):1137-449.Sherman et al. Duration of Initial Telaprevir Treatment for HCV Infection: A phase 3 study of treatment duration, N Engl J Med. 2011: 365; 1014-24.10.McHutchinson et al. Telaprevir for Previously Treated Chronic HCV Infection. Engl J Med. 2010; 362; 1292-1303.11.Hezode et al. Telaprevir and Peginterferon Alfa with or without Ribavirin for Chronic HCV. Engl J Med 2009; 360; 1839-50.12.McHutchinson et al. Telaprevir with Peginterferon Alfa and Ribavirin for Chronic HCV Genotype 1 Infection 2009 N Engl J Med 2009; 360: 1827-38.
For more information:http://www.janssen.co.uk
Read more: http://www.pharmiweb.com/pressreleases/pressrel.asp?ROW_ID=52319#ixzz1hNu34mYg
Telaprevir Effective in Hard-to-Treat Cirrhotic HCV
Adding the recently approved protease inhibitor telaprevir to pegylated interferon (peginterferon) plus ribavirin therapy achieved a 47% sustained viral response (SVR) in hard-to-treat patients with hepatitis C virus (HCV) infection and cirrhosis who had previously failed the standard 2-drug regimen. This finding comes from a subset analysis of the phase 3 REALIZE trial, presented here at The Liver Meeting 2011: American Association for the Study of Liver Diseases 62nd Annual Meeting....
Nov 16
Telaprevir Reduces Duration of Standard Treatment for Hepatitis C by Half 24-week Telaprevir-based Therapy Noninferior To 48-week Therapy, With Fewer Adverse Events
By Christina Frangou
The treatment duration of peginterferon and ribavirin can be cut in half—from 48 weeks to 24—following 12 weeks of treatment with telaprevir in patients with chronic hepatitis C virus (HCV) genotype 1 infection who have an extended rapid virologic response (eRVR), according to results from a Phase III clinical trial. Kenneth E. Sherman, MD, PhD, professor of medicine, University of Cincinnati, and colleagues reported their findings in the Sept. 15 issue of The New England Journal of Medicine (365:1014-1024).
The study showed that a 24-week regimen of peginterferon and ribavirin was noninferior to a 48-week regimen following 12 weeks of triple therapy with telaprevir in patients with chronic HCV infection who had not received previous treatment and who had an eRVR. Seventy-two percent of all patients who entered the study (n=540) had a sustained virologic response (SVR) and 65% had an eRVR. The patients with an eRVR were randomly assigned to receive peginterferon and ribavirin for an additional four or 28 weeks. Among patients with an eRVR, 92% in the 24-week treatment group and 88% in the 48-week group had an SVR. Overall, 18% of patients discontinued treatment due to adverse events (AEs)—1% in the 24-week group compared with 12% in the 48-week group (P<0.001). AEs included rashes (37%) and anemia (39%).
“These results are likely to change treatment standards for patients with hepatitis C and reduce adverse effects of the treatment regimen,” said Dr. Sherman in a statement issued by the University of Cincinnati. “The high viral cure rates showed that there was no benefit to extending the therapy to 48 weeks for the majority of people in this trial.”
He added, “importantly, patients in this trial had a high likelihood of achieving a cure with 24 weeks of total therapy if they had a rapid response to these regimens by week four. Knowing this may provide important motivation for people to continue therapy.”
The study provides physicians with “an absolutely solid foundation of confidence that, provided the appropriate response criteria are met, telaprevir-based therapy can be stopped after 24 weeks without impairing the patient’s chance of sustained response,” said Ira M. Jacobson, MD, chief of gastroenterology and hepatology and the Vincent Astor Distinguished Professor of Clinical Medicine at The Joan Sanford I. Weill Medical College of Cornell University, New York. The study confirms earlier nonrandomized trial results that suggested a 24-week therapy was sufficient for patients who took telaprevir and met the appropriate criteria for viral undetectability at four and 12 weeks, he said.
Patients with cirrhosis were too few in the Phase III trials to draw definitive conclusions about duration of treatment. The FDA packaging states that these patients “may benefit” from extending therapy to 48 weeks.
“I do plan to give very strong consideration to heed the package insert and strongly consider extending therapy in the cirrhotic patients who have an eRVR,” said Dr. Jacobson.
The trial was funded by Vertex Pharmaceuticals and Tibotec. Dr. Jacobson reported the following disclosures: Achillion Pharmaceuticals, Anadys Pharmaceuticals, Biolex, Boehringer Ingelheim, Bristol-Myers Squibb, Genentech, Gilead, GlaxoSmithKline, GlobeIummune, Human Genome Sciences, Merck, Novartis, Pfizer, Pharmasset, Roche, Schering, Tibotec, Vertex Pharmaceuticals and ZymoGenetics.
Vertex Initiates Phase 3b CONCISE-Study Incivek w-peg/riba
Vertex Pharmaceuticals Incorporated today announced the initiation of a Phase 3b study called CONCISE that will evaluate the potential for treatment with INCIVEK™ (telaprevir) combination therapy to be shortened to 12 weeks in people with genotype 1 chronic hepatitis C who have the ‘CC' variation near the IL28B gene.
Hey Doc, Victrelis-boceprevir or Incivek-telaprevir?
Helping People Get INCIVEKTM (telaprevir) tablets
Oct 11
Janssen’s new hepatitis C treatment Incivo has been launched in the UK, one of two new drugs set to advance treatment
.Incivo (telaprevir) is a new direct acting antiviral protease inhibitor (PI), for genotype-1 chronic hepatitis C, and can help clear the virus from many more patients when added to standard treatment, peginterferon alfa and ribavirin.Trials show that adding Incivo clears the virus in almost twice as many previously untreated patients (79% vs. 46%) and almost four times as many who had previously relapsed following treatment (84% vs. 22%). The drug also halved the current total treatment duration to six months in many (58%) previously untreated patients in trials.
INCIVEK(TM) (telaprevir) Now Available in Canada
LAVAL, Quebec, Oct 11, 2011 (BUSINESS WIRE) -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that INCIVEK(TM) (telaprevir) tablets are now available in Canada for people with genotype 1 chronic hepatitis C with compensated liver disease (some level of damage to the liver, but the liver still functions), including cirrhosis (scarring of the liver). INCIVEK (in-SEE-veck) was approved by Health Canada in August 2011 for use in combination with pegylated-interferon and ribavirin, two other medicines approved to treat hepatitis C, and is indicated for people who are new to treatment, and for all three major groups of people (relapsers, partial responders and null responders) who were treated previously but who did not achieve a sustained viral response (SVR, or viral cure).
Sept 20
European approval for hepatitis C drug, Telaprevir-Incivek "called Incivo in Europe."
Sept 15
Two-Thirds of Hepatitis C Patients Can See a Cure in Half the Time
Released: 9/15/2011 8:00 AM EDT
Source: Cedars-Sinai Medical Center
Newswise — LOS ANGELES (Sept. 15, 2011) – Treatment with a telaprevir-based combination regimen for hepatitis C – heretofore a chronic, destructive and difficult to manage disease – effectively can be shortened to six months in about two-thirds of patients, finds a new study published Thursday in the New England Journal of Medicine.
Telaprevir, a drug approved for use against hepatitis C in May, inhibits replication of virus. This anti-viral drug and a similar medication called boceprevir have nearly doubled the number of patients with sustained response. Among patients treated with teleprevir, pegylated interferon and ribavirin in the new study, 72 percent were cured of their hepatitis C.
This study shows that two-thirds of patients can be cured in half the time: Patients who are clear of the virus within the first four to 12 weeks of therapy effectively can cut their treatment time from 48 weeks to six months. Besides the considerable benefits to patients of shorter treatment, these findings also show that response-guided therapy is a successful strategy.
“This means that rather than a one-size-fits-all approach, we can individualize treatment for patients based on their specific response to the drugs,” said Fred Poordad, MD, chief of Hepatology and Liver Transplantation at Cedars-Sinai and a senior author on the study. “Once you’re cured by these anti-viral drugs, you’re cured of hepatitis C completely. That’s a little known fact among the public – and even among physicians who don’t regularly treat liver disease.
Cedars-Sinai is one of the major research sites investigating new treatments for hepatitis C; the medical center is involved in developing most of these new compounds. Earlier this year, Dr. Poordad was the lead author of a study published in the New England Journal of Medicine on the anti-viral drug boceprevir, also an oral protease inhibitor. In that study, 1,097 patients with hepatitis C who had never been treated for the virus received standard treatment – pegylated interferon and ribavirin – for four weeks. Then, a third of the patients continued only on those drugs, while two other groups also received different durations of boceprevir. The boceprevir patients responded well, with 63 percent and 66 percent achieving sustained virus suppression – compared to 38 percent among patients taking only pegylated interferon and ribavirin.
According to the Centers for Disease Control, an estimated 3.2 million people in the United States have chronic hepatitis C virus infections. The disease is spread through virally infected blood, often by sharing of syringes or other equipment to inject drugs; prior to 1990, some infections can be attributed to blood transfusions. Some rare infections can be traced to medical procedures. Chronic hepatitis C is the leading cause of liver cancer and cirrhosis and is the chief reason for the need for liver transplants in the U.S. The disease is linked to as many as 10,000 deaths each year.
In the new telaprevir study, funded by Vertex Pharmaceuticals in Cambridge, Mass., a total of 540 patients were enrolled. They took a 12-week course of 750 milligrams of telaprevir three times a day in addition to therapy with pegylated interferon and ribavirin. Patients eligible for shortened treatment – meaning the virus was not detectable in the first month of treatment – were randomized to receive either 24 weeks or 48 weeks of treatment. The high cure rates among both groups showed that there was no benefit to additional treatment for early responders.
For patients, the shorter course of treatment means decreased costs, fewer side effects and less disruption to their daily lives, as this therapy requires intensive monitoring and laboratory visits.
Dr. Poordad has received research grants and served as an adviser and consultant for Vertex Pharmaceuticals, which makes telaprevir, and Merck, which makes boceprevir.
Sept 13
Oral telaprevir in previously untreated patients with hepatitis C virus genotype 1 infection
The ADVANCE trial (n = 1,095) found that in previously untreated patients with genotype 1 hepatitis C infection and a baseline hepatitis C virus RNA level of 800,000 IU/ml or more, the addition of oral telaprevir to standard therapy with peginterferon alfa-ribavirin was significantly more effective than standard treatment alone. A total of 75% of patients who received peginterferon alfa-ribavirin plus telaprevir for 12 weeks followed by peginterferon alfa-ribavirin for 12 or 36 weeks (depending on response) had a sustained virologic response, compared to 44% of patients on standard therapy for 48 weeks. Similarly, 69% of the group who received standard therapy plus telaprevir for 8 weeks followed by peginterferon alfa-ribavirin for 16 or 40 weeks had a sustained virologic response. A total of 58% of patients were eligible for the 24 weeks of total treatment duration.
Anaemia (defined as a haemoglobin level < 10 g/dl) occurred in 38% of patients who received telaprevir compared to 19% in the standard treatment group and rash occurred in 36% and 24%, respectively.
Level of evidence:
Level 3 (other evidence) according to the SORT criteria.
Action
The European Medicines Agency (EMA) has recently adopted a positive opinion, recommending the granting of a marketing authorisation for telaprevir (Incivo). It is indicated, in combination with peginterferon alfa and ribavirin, for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease (including cirrhosis) who are treatment‑naïve or who have previously been treated with interferon alfa alone or in combination with ribavirin, including prior relapsers, partial responders and null responders.
This published study will need to be taken into account by local decision-makers when managing the entry of new medicines and planning the commissioning of appropriate services. Publication of NICE guidance is anticipated in June 2012. The Scottish Medicines Consortium (SMC) telaprevir appraisals are also underway, with advice due potentially mid-December 2011.
The company has provided information that the telaprevir eight-week dosing schedule is not recommended as a treatment strategy and will not be part of the licence. However, factors to take into account are the number of patients who may be eligible for treatment, their baseline hepatitis C virus RNA level, the number of patients expected to be eligible for shorter response guided treatment durations and the incidence of anaemia, which may require reduction in dose of ribavirin or blood transfusion.
What is the background to this?
The blood-borne hepatitis C virus (HCV) predominately infects the cells of the liver. The virus is usually acquired through parenteral exposure to contaminated blood. Infected needles used for injecting drugs are the most common means of transmission. Six major genotypes of HCV are known, with genotype 1 being the most common in England and Wales. Genotype is a key predictor of the effectiveness of anti-viral treatment and people with genotype 1 have HCV that is the most resistant to treatment.
In approximately 80% of people who are infected, the virus is not cleared and they go on to develop chronic hepatitis C. The Health Protection Agency estimates that around 216,000 individuals in the UK are chronically infected with hepatitis C. Standard therapy is with peginterferon alfa and ribavirin and information on the appropriate use of these drugs is available from NICE guidance.
Telaprevir is an oral protease inhibitor. The EMA has recently adopted a positive opinion, recommending the granting of a marketing authorisation for telaprevir tablets (Incivo). Telaprevir, in combination with peginterferon alfa-ribavirin, is indicated for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease (including cirrhosis) who are treatment‑naïve or who have previously been treated with interferon alfa alone or in combination with ribavirin. Patients covered within this indication include relapsers, partial responders and null responders.
Further information on the management of hepatitis can be found on NHS Evidence.
What does this study claim?
Previously untreated adults with HCV genotype 1 infection were randomly assigned to one of three groups. The T12PR group received peginterferon alfa-ribavirin and telaprevir for 12 weeks. The T8PR group received peginterferon alfa-ribavirin and telaprevir for 8 weeks, then placebo plus peginterferon alfa-ribavirin for 4 weeks. Patients in the telaprevir groups with an extended rapid virologic response received an additional 12 weeks of peginterferon alfa-ribavirin. Patients who had detectable HCV RNA at either week 4 or 12 received an additional 36 weeks of peginterferon alfa-ribavirin. A third group received placebo combined with standard therapy of peginterferon alfa-ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-ribavirin. The primary endpoint was sustained virologic response.
The addition of telaprevir to standard therapy with peginterferon alfa-ribavirin was significantly more effective than standard therapy alone. A total of 271/363 patients (75%) in the T12PR group, 250/364 patients (69%) in the T8PR group and 158/361 patients (44%) on standard therapy had a sustained virologic response (p < 0.001 for both telaprevir doses versus standard therapy). A total of 58% of patients who received telaprevir were eligible to receive 24 weeks of treatment i.e. they had an extended rapid virologic response.
Overall, the incidence of adverse events and serious adverse events were similar in all three groups. However, gastro-intestinal disorders, rash and anaemia were more common in patients who received telaprevir. 37% of patients in the T12PR group and 35% of patients in the T8PR group experienced rash, compared to 24% in the standard therapy group. Anaemia, defined as a haemoglobin level of < 10 g/dl, was seen in 37% of the T12PR group, 39% of the T8PR group and 19% of the standard therapy group (p values not quoted).
How does this relate to other studies?
The use of telaprevir with standard treatment of peginterferon alfa-ribavirin in previously treated patients was compared to standard treatment alone in the REALIZE study. The OPTIMIZE-HCV study to investigate different dosing regimens for telaprevir in treatment-naïve patients is on-going and is estimated to complete in October 2012.
Another oral protease inhibitor, boceprevir(Victrelis), has recently been launched. It is licensed for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa-ribavirin, in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy. A NICE appraisal is anticipated in May 2012. Data in previously untreated patients came from SPRINT-2 (n = 1,097), which found that boceprevir given three times a day, plus standard therapy of peginterferon alfa-ribavirin, significantly increased rates of sustained virologic response compared to standard therapy in adult patients with treatment-naïve hepatitis C virus genotype 1 infection. Further details can be found in a previous rapid review. A four-week lead-in period of peginterferon alfa-ribavirin was used in the boceprevir trial, but not in the ADVANCE trial with telaprevir.
So what?
As compared with peginterferon alfa-ribavirin therapy alone, the addition of telaprevir increased the rate of sustained virologic response among previously untreated adults infected with HCV genotype 1 and a high baseline HCV RNA level (> 800,000 IU/ml). Inclusion criteria for the ADVANCE trial specified that patients had to have a liver biopsy with histology consistent with chronic hepatitis C infection and no other aetiology, genotype 1 only, seronegativity for hepatitis B surface antigen, the absence of HIV and specified levels for neutrophil counts and haemoglobin levels. This may limit generalisation to patients seen in normal clinical practice.
In the ADVANCE study, the T12PR dosing schedule for TVR was found to demonstrate a better benefit: risk profile than the T8PR schedule. As a result of this finding, research around the T8PR dosing schedule was ceased; it is not recommended as a treatment strategy and is not part of the licence.
The primary endpoint in this report of the ADVANCE study is a disease-oriented outcome, sustained virologic response. However, the trial did include outcomes related to quality of life, fatigue and productivity, but these have not been reported yet.
The authors of ADVANCE note that rates of sustained virologic response to standard therapy are around 40–50% in patients with genotype 1 infection who had received no previous therapy. Most patients require at least 48 weeks of treatment. The ADVANCE trial showed that shorter courses can be effective when telaprevir is added to standard therapy. Potential concerns with triple therapy include the increasing complexity of treatment regimens, a possible increased risk of anaemia and the potential need for a reduction in the dose of ribavirin or the use of a blood transfusion.
The telaprevir regimens were associated with a higher incidence of skin reactions than standard therapy. The majority of skin reactions were mild to moderate and did not lead to discontinuation of the drug. In those cases where telaprevir was stopped the rash was reversible after discontinuation. One case of Stevens-Johnson syndrome occurred. In the US, where telaprevir is already on the market, the prescribing information notes that serious skin reactions, including Stevens-Johnson syndrome have been reported rarely in trials and provides advice on patient care in such situations.
Study details: Jacobson IM, McHutchison JG, Dusheiko G et al for the ADVANCE Study Team. Telaprevir for Previously Untreated Chronic Hepatitis C Virus Infection. N Engl J Med 2011; 364:2405-16
Design: Phase III, randomised, double-blind, placebo-controlled trial. Randomisation was stratified according to baseline HCV RNA level (< 800,000 or > 800,000 IU/ml) and HCV genotype 1 subtype (1a, 1b or unknown).
Patients: Previously untreated adults with chronic hepatitis C genotype 1 infection as confirmed by a liver biopsy within one year before screening. Patients with compensated liver cirrhosis were eligible. Included patients had a median age of 49 years. Exclusion criteria included liver disease due to other causes, decompensated liver disease, low haemoglobin levels, HIV and hepatocellular carcinoma.
Intervention and comparison: Peginterferon alfa-2a was given subcutaneously at a dose of 180 microgram per week. Oral ribavirin was taken as 1000 mg or 1200 mg daily, depending on body weight. Oral telaprevir was taken as 750 mg every 8 hours. Total treatment duration was either 24 or 48 weeks. Patients were randomised to one of three groups as follows:
Standard therapy (n = 361) consisting of peginterferon alfa-ribavirin plus placebo for 12 weeks then peginterferon alfa-ribavirin for 36 weeks.
T12PR (n = 363) consisting of peginterferon alfa-ribavirin and telaprevir for 12 weeks or the T8PR group (n = 364) consisting of peginterferon alfa-ribavirin and telaprevir for 8 weeks, then placebo plus peginterferon alfa-ribavirin for 4 weeks. If patients in the telaprevir groups had an extended rapid virologic response (defined as undetectable HCV RNA at weeks 4 and 12) they received an additional 12 weeks of peginterferon alfa-ribavirin. If patients had a detectable HCV RNA level at either week 4 or 12 they received an additional 36 weeks of peginterferon alfa-ribavirin.
Patients who did not have an adequate response, defined as patients given telaprevir whose HCV RNA levels were greater than 1000 IU/ml at week 4, stopped telaprevir but continued with peginterferon alfa-ribavirin. Any patient who had less than 2 log10 reduction from baseline to week 12 in HCV RNA stopped treatment. Treatment also stopped if HCV RNA was detectable at anytime between weeks 24 and 40.
Outcomes and results: Analyses were based on 1,088 patients who took at least one dose of study drug out of a total of 1,095 randomised patients. The primary outcome was the proportion of patients with undetectable HCV RNA levels 24 weeks after the last planned dose of study drug (sustained virologic response). Sustained virologic response was seen in 271/363 patients (75%) in the T12PR group, 250/364 patients (69%) in the T8PR group and 158/361 patients (44%) in the control group, P<0.001 for both doses versus standard treatment. A total of 58% of patients receiving telaprevir were eligible to receive 24 weeks of treatment as compared with 8% of those on standard therapy. Relapse was reported in 9% of the telaprevir groups compared to 28% of the standard treatment group (no p value given).
Patients with high baseline viral load (> 800,000 IU/ml) had better rates of sustained virologic response in the telaprevir groups than standard therapy; 74% in the T12 PR group, 66% in the T8PR group and 36% for standard therapy (p value not stated). Patients with a lower viral load did not benefit from the addition of telaprevir.
Gastro-intestinal adverse events were more common in patients who received telaprevir. Nausea was experienced by 43% of the T12PR group and 40% of those in T8PR compared with 31% of those receiving standard therapy. A total of 37% of the T12PR group and 35% of the T8PR group experienced rash compared with 24% of the standard therapy group. The rash was classified as serious in five patients receiving telaprevir. A total of 7% of patients in the T12PR regime discontinued telaprevir owing to rash. The rashes resolved with the discontinuation of the drug. One case of Stevens-Johnson syndrome was seen about 11 weeks after the last dose of telaprevir. Anaemia was seen in 37% of the T12PR group, 39% of the T8PR group and 19% of the control group. Anaemia during the trial was managed with dose reduction of ribavirin. If ribavirin was stopped due to anaemia, telaprevir or placebo was also stopped. The use of erthyropoietin was not allowed. A total of 5% of patients in the telaprevir groups received blood transfusions compared to 2% of patients on standard therapy. Anaemia was one of the reasons patients discontinued treatment. This occurred in 1% of the T12PR group, 3% of the T8PR group and less than 1% of those in the control group.
Sponsorship
This study was sponsored by Vertex Pharmaceuticals and Tibotec.
Sept 1
Trial Supports Addition of Telaprevir for HCV Genotype 2
Aug 31
Telaprevir Markedly Improves HCV Genotype 1 Cure Rates
From Journal Watch ; Journal Watch Gastroenterology
Atif Zaman, MD, MPH
Authors and Disclosures
Posted: 08/31/2011; Journal Watch © 2011 Massachusetts Medical Society
Abstract and Introduction
Abstract
Final results of phase III trials show that telaprevir plus standard therapy with peginterferon alfa-2a and ribavirin was more effective than standard therapy alone.
Introduction
Recently, telaprevir-based triple therapy (i.e., in combination with peginterferon alfa-2a and ribavirin) was approved for the treatment of chronic hepatitis C virus (HCV) infection. The final results of the international phase III trials for both treatment-naive and treatment-experienced patients with HCV genotype 1 infection are now available.
In the first of two industry-sponsored, double-blind, placebo-controlled trials, 1095 treatment-naive patients were randomized to receive either triple therapy for 12 weeks followed by peginterferon plus ribavirin for 12 weeks — or 36 weeks if HCV RNA was detectable at weeks 4 or 12 — (T12PR group); triple therapy for 8 weeks followed by peginterferon plus ribavirin for either 16 or 36 weeks (T8PR group); or peginterferon plus ribavirin for 48 weeks (PR group).
In the second trial, 663 treatment-experienced patients were randomized 2:2:1 to receive either triple therapy for the first 12 weeks followed by 36 weeks of peginterferon plus ribavirin (T12PR48 group), a 4-week lead-in of peginterferon plus ribavirin followed by 12 weeks of triple therapy and then 32 weeks of peginterferon plus ribavirin (lead-in T12PR48 group), or peginterferon plus ribavirin for 48 weeks (PR48 group). In both trials, doses were 750 mg every 8 hours for telaprevir, 180 µg weekly for peginterferon alfa-2a, and 1000–1200 mg daily for ribavirin. The primary endpoint was sustained virologic response (SVR).
For treatment-naive patients, SVR rates were higher in the T12PR and T8PR groups than in the PR group — 75% and 69% versus 44%; P<0.001. Although the numbers of patients who were black or had advanced fibrosis were small in the study cohort (7% and 20%, respectively), in both subgroups, SVR rates were higher in the telaprevir groups than the peginterferon plus ribavirin group. Among treatment-experienced patients, SVR rates for arms T12PR48, lead-in T12PR48, and PR48, respectively, were 83%, 88%, and 24% for previous relapse; 59%, 54%, and 15% for previous partial response; and 29%, 33%, and 5% for previous null response (P<0.001 for all comparisons).
In general, virologic failure in the telaprevir groups was attributable primarily to the development of drug resistance. In both studies, the telaprevir groups had higher rates of anemia, rashes, pruritus, and gastrointestinal problems than the peginterferon plus ribavirin group. Discontinuation of medications for any reason ranged from 10% to 15% for the telaprevir regimens and from 7% to 10% for the peginterferon plus ribavirin regimen
Comment
These companion studies demonstrate that telaprevir-based regimens are significantly more effective in HCV genotype 1–infected patients than peginterferon plus ribavirin alone — for both treatment-naive and treatment-experienced patients. Although more adverse events occurred in the telaprevir-treated groups, discontinuation rates were still relatively low. Overall, the best SVRs were seen in treatment-naive and prior-relapse patients (≥75%), followed by previous partial responders, treatment-naive blacks, and patients with advanced fibrosis (50%–60%), and last, previous null responders (30%). Therefore, caution should be exercised in treating null responders, especially since the majority of virologic failure leads to drug resistance.
References
Aug 22
Health Canada Okays INCIVEK For People With Hepatitis C
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Health Canada has approved INCIVEK™ (telaprevir) tablets for a broad group of people with genotype 1 chronic hepatitis C with compensated liver disease (some level of damage to the liver but the liver still functions), including cirrhosis (scarring of the liver). INCIVEK (in-SEE-veck) is approved for use in combination with pegylated-interferon and ribavirin, two other medicines approved to treat hepatitis C, and is indicated for people who are new to treatment, and for people who were treated previously but who did not achieve a sustained viral response (SVR, or viral cure). INCIVEK is approved for use in all three major groups of people who did not achieve a viral cure despite prior treatment including: relapsers, partial responders and null responders.
“Early diagnosis and the effective treatment of hepatitis C are critical to the prevention of long-term consequences of the disease, which may include end-stage cirrhosis, liver cancer and the need for a transplant,” said Eric Yoshida, M.D., Professor of Medicine and Head, Division of Gastroenterology at the University of British Columbia and an INCIVEK investigator. “INCIVEK is an important new treatment option because it has been shown to help clear the virus for nearly four out of five patients new to treatment.”
“Health Canada’s rapid approval of INCIVEK underscores the urgent need for new medicines to treat hepatitis C, which affects about a quarter of a million Canadians,” said Robert Kauffman, M.D., Ph.D., Senior Vice President and Chief Medical Officer for Vertex. “Until recently, approximately 40 percent of people who underwent a year of treatment for hepatitis C were cured. INCIVEK’s ability to nearly double that rate of cure and cut treatment time in half for the majority of patients being treated for the first time marks a turning point in the fight against this disease.”
INCIVEK is given as two 375-mg tablets, three times daily. It is given for 12 weeks in combination with pegylated-interferon and ribavirin. After the first 12 weeks, all patients stop receiving INCIVEK and continue treatment with pegylated-interferon and ribavirin alone for an additional 12 weeks or 36 weeks of treatment. With INCIVEK combination treatment, more than 60 percent of people treated for the first time, as well as those who relapsed after previous therapy, are expected to complete all treatment in 24 weeks — half the time needed if they were to take pegylated-interferon and ribavirin alone. All other patients will receive a total of 48 weeks of treatment. Rash and anemia are the most serious side effects associated with INCIVEK. The most common side effects reported with INCIVEK combination treatment include fatigue, itching, nausea, diarrhea, vomiting, anal or rectal problems, and taste changes.
The approval of INCIVEK was based on data from three Phase 3 studies of more than 2,500 people with hepatitis C, which showed that people who received INCIVEK combination treatment achieved significantly higher rates of viral cure (sustained viral response, or SVR) compared to those who received pegylated-interferon and ribavirin alone, regardless of their prior treatment experience:
People new to treatment:
79 percent vs. 46 percent People who were treated previously but did not achieve a viral cure:
-- Relapsers:
86 percent vs. 22 percent -- Partial responders:
59 percent vs. 15 percent -- Null responders:
32 percent vs. 5 percent Data from the Phase 3 REALIZE and ADVANCE studies were published on June 23, 2011 in the New England Journal of Medicine.
“As the world’s first organization dedicated to providing support for research and education into the causes, diagnoses, prevention and treatment of all liver disease, we are all too familiar with the devastating consequences of hepatitis C,” said Morris Sherman, Ph.D., FRCPC, M.B., Chairman of the Canadian Liver Foundation (CLF) and an INCIVEK investigator. “We applaud the approval of new medicines like INCIVEK that can significantly improve the treatment of hepatitis C and hope that all Canadians who need treatment will have access to these medical advances.”
Indication
INCIVEK™ (telaprevir) is a prescription medicine that treats a disease in adults called chronic hepatitis C (chronic means lasting a long time). INCIVEK does not work by itself. It is always used in combination with peginterferon alfa and ribavirin.
Important Safety Information
INCIVEK must always be used in combination with peginterferon alfa and ribavirin to treat chronic hepatitis C. A female patient should not take INCIVEK combination treatment if she is or plans to become pregnant, and until six months after treatment ends. A male patient should not take INCIVEK combination treatment if he has a sexual partner who is pregnant or may become pregnant any time during treatment, and until six months after treatment ends.
INCIVEK combination treatment may cause a rash that can become severe. It may also cause a serious skin reaction, a rare side effect. Patients will have their blood checked for anemia and other possible blood problems. Drugs that cause an effect on the electrical conduction of the heart known as QTc prolongation should be taken with caution in patients taking INCIVEK.
Certain medicines can cause serious or life threatening reactions with INCIVEK. Patients should tell their health care provider about all the medicines they take, including over-the-counter medicines, vitamins and herbal medicines.
The most common side effects of INCIVEK include rash, itching, anal or rectal problems, anemia, nausea, diarrhea, vomiting, and taste alteration. This is not a complete list of side effects. Patients should tell their health professional about any unexpected effects or any side effect that bothers them or does not go away.
For more information or questions about INCIVEK please call 1-877-634-VRTX (8789).
About Hepatitis C
Hepatitis C is a serious liver disease caused by the hepatitis C virus, which is spread through direct contact with the blood of infected people and ultimately affects the liver.1 Chronic hepatitis C can lead to serious and life-threatening liver problems, including liver damage, cirrhosis, liver failure or liver cancer.1 Though many people with hepatitis C may not experience symptoms, others may have symptoms such as fatigue, fever, jaundice and abdominal pain.1
Unlike HIV and hepatitis B virus, chronic hepatitis C can be cured.2 However, approximately 60 percent of people do not achieve SVR,3,4,5 or viral cure,6 after treatment with 48 weeks of pegylated-interferon and ribavirin alone. If treatment is not successful and a person does not achieve a viral cure, they remain at an increased risk for progressive liver disease.7,8
More than 170 million people worldwide are chronically infected with hepatitis C.6,9
Hepatitis C in Canada
Approximately 250,000 people in Canada have chronic hepatitis C and more than a third of them do not know they are infected. 9 Three provinces account for 80 percent of hepatitis C infections in Canada: Ontario (42 percent), British Columbia (22 percent) and Quebec (16 percent).10 Each year up to 5,000 people are newly infected with hepatitis C in Canada and in 2007 alone, nearly 8,000 people were infected.12,13 In 2010, the annual cost of hepatitis C due to medical treatment and lost productivity in Canada was estimated to reach $1 billion.11 By 2022, the number of hepatitis C-related deaths is expected to increase by one-third.12
Additional resources for media are available at: http://investors.vrtx.com/press.cfm.
About Vertex
Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives.
Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, epilepsy and other life-threatening diseases.
Founded more than 20 years ago in Cambridge, MA, we now have ongoing worldwide research programs and sites in the U.S., U.K. and Canada.
About Vertex in Canada
In 2009, Vertex established a research and development site in Laval, Quebec through the acquisition of Virochem Pharma, Inc. Vertex is expanding its existing research and development infrastructure with the addition of commercial and medical teams to support the anticipated launch of INCIVEK (telaprevir) in Canada.
For more information on Vertex, including career opportunities with Vertex Canada, and to view Vertex's press releases, please visit www.vrtx.com
. http://www.istockanalyst.com/business/news/5371084/health-canada-approves-incivek-tm-telaprevir-for-people-with-hepatitis-c
Related;Health Canada Clears Victrelis-Boceprevir New Hepatitis C Drug http://hepatitiscnewdrugs.blogspot.com/2011/0...
Aug 19
Update; Check out two new videos;
Patient Video; New HCV New Drugs and Resistance
Telaprevir Alone or With Peginterferon and Ribavirin Reduces HCV RNA in Patients With Chronic Genotype 2 But Not Genotype 3 Infections
July
Update Telaprevir-Incivek; Video on retreatment and previously untreated chronic hepatitis C patients
Telaprevir Effective After Prior Treatment Failure
Emerging therapies for hepatitis C offer a significant increase in SVR and bring treatment complexity
June
Telaprevir for Retreatment of HCV Infection - NEJM published
This article reviews the evaluation and initial management of chronic hepatitis C infection, with particular attention to the use of new directly acting antiviral agents in treatment regimens.
Telaprevir for Previously Untreated Chronic Hepatitis C Virus Infection -
In patients with HCV infection and no previous treatment, the addition of telaprevir to peginterferon–ribavirin resulted in higher response rates than those achieved with peginterferon–ribavirin alone. High rates of response were achieved with only 24 weeks of treatment.
Telaprevir/Incivek Isn't Useful for All HCV Genotypes
New Treatments For Hepatitis C; Boceprevir vs Telaprevir: What We Know and Don't Know
Telaprevir FDA Approved May 23
FDA OKs Telaprevir for Hep C; Financial Assistance/Prescribing Information
Hepatitis C News; Its All About Incivek/Telaprevir
May 3
Vertex drug has a new name
The recent progress update mentioned that Vertex will be calling Telaprevir "INCIVEK", noted previously Merck's boceprevir has been registered as VICTRELIS.
In the fourth quarter of 2011, Vertex plans to initiate a Phase 2 study in the U.S. of INCIVEK dosed in combination with pegylated-interferon and ribavirin in people with recurrent hepatitis C following a liver transplant.
In the third quarter of 2011, Vertex plans to initiate a clinical trial to evaluate a 12-week treatment regimen of INCIVEK (telaprevir) dosed in combination with pegylated-interferon and ribavirin for people who have a specific genetic marker, known as CC, near the IL28B gene...read more
http://hepatitiscnewdrugs.blogspot.com/2011/05/update-telaprevirvertex-plans-us-phase.html
Medpage Today;
FDA Panel Endorses Another Hep C Drug
4/28/2011 MedPage Today Gastroenterology
(MedPage Today) -- SILVER SPRING, Md. -- Hepatitis C patients will likely have two new treatment options after an FDA advisory committee unanimously endorsed a second new HCV drug in as many days.
April 2 2011
Drug-resistant variants emerge in most patients who fail to achieve SVR with telaprevir-based regimen
Hepatitis C ; Telaprevir Helps in Prior HCV Tx Failures
Better Then SOC; Improvements in Viral Cure Rates W-Telaprevir-Based TX Regardless of IL28B Genotype
March 31
EASL Telaprevir Improved SVR Rates in People Whose Prior Treatment For Hepatitis C Was Unsuccessful
Vertex"Telaprevir" Wants CDC To Recommend Hep C Screening
Feb 2 2011
If Vertex Pharmaceuticals gets its way in talks with U.S. public health officials, most people over 50 could soon get blood tests to screen for hepatitis C infections at the doctor’s office. If the U.S. Centers for Disease Control and Prevention (CDC) agrees this is a good idea, it could prompt another 1 million patients who don’t realize they are infected to come out of the woodwork and start clamoring for Vertex’s new hepatitis C drug over the next few years.
The Cambridge, MA-based biotech company (NASDAQ:
Continue Reading...............Next Page »
Telaprevir Continues to Show Promise for Hepatitis C Patients
by Dr. Joe Galati
February 1, 2011
In a recent report, there are continued signs that Telaprevir in combination with Interferon and Ribavirin will have significantly increased rates of clearing the hepatitis C virus. New agents against hepatitis C are due for FDA approval in the second half of 2011. For the past three years, we have been fortunate at Liver Specialists of Texasto have been participating in these clinical studies, and remain active with over 15 ongoing hepatitis C research studies. If you are interested in research opportunities, call us 713-794-0700.
In patients with chronic hepatitis C, combining telaprevir with ribavirin and peginterferon alfa-2a or 2b yielded sustained virologic response rates of more than 80%, regardless of which type of interferon or which dosing regimen of telaprevir was used, Dr. Patrick Marcellin and his colleagues reported in the February issue of Gastroenterology...
continue reading...
UPDATE 1-Vertex Pharma's Hep C drug gets priority review
"Administration for a priority review of data from telaprevir in November, said the agency set an action date for May 23 to decide on the approval."
Thu Jan 20, 2011 8:08am EST
* Drug gets priority review status from FDA, Health Canada
* FDA sets action date for May 23
Jan 20 (Reuters) - Vertex Pharmaceuticals Inc (VRTX.O) said its experimental treatment for Hepatitis C got priority review status from health regulators in the United States and Canada.
Cambridge, Massachusetts-based Vertex, which had asked the U.S. Food and Drug Administration for a priority review of data from telaprevir in November, said the agency set an action date for May 23 to decide on the approval.
Priority review status from the FDA reduces the review period by four month, the company said. The same status from Canadian health regulator Health Canada cuts short the review period to six to nine months, compared to a review period of 18 months or more.
Vertex is developing telaprevir in collaboration with Tibotec Pharmaceuticals, a unit of Johnson & Johnson (JNJ.N), and Mitsubishi Tanabe Pharma (4508.T).
Vertex holds rights to market the drug in North America while Tibotec has rights to market it in Europe, South America, Australia, the Middle East and certain other countries. Mitsubishi Tanabe has rights in Japan and certain Far East countries.
Shares of Vertex have risen 15 percent since it applied for the priority review. They closed at $39.45 Wednesday on Nasdaq. (Reporting by Vidya L Nathan in Bangalore
News
Feb 25 2011
Scripps Health ;IL28B Genetic Testing to Hepatitis C Patients Now AvailableJan 2011
2011 Hepatitis C Drugs Telaprevir and Boceprevir: I'm Still Waiting
________________________________
2010
Dec
Video/Vertex Halted Part Of Telaprevir/VX-222 Study
Today, December 22, 2010, 1 hour agoHepatitis C News Of The Day Vertex Pharmaceuticals Inc. discontinued one part of a clinical study evaluating its hepatitis C treatments. Vertex is halting a test of its medicine telaprevir in combination with its other experimental therapy called VX-222, the Cambridge, Massachusetts-based company said in a statement. Vertex will continue testing telaprevir and VX-222 in groups of patients who will receive it with one or two drugs given as a combination treatment. The study is the second of three phases of clinical tests typically required for U.S. approval.
Telaprevir Hepatitis C Drug Has Been Submitted To EuropeHepatitis C: Telaprevir and HCV NS3-4A is covalent yet reversible, with a slow-on, slow-off process
Dec 17
Hepatitis C Drug Development Progress/Telaprevir, Boceprevir 2010
Nov
Hepatitis C New Drugs:Telaprevir,Boceprevir Potential for Misuse Is ‘Huge’
Nov 18
AASLD/2010 Telaprevir 3 Studies Showed Superior SVR (Viral Cure)Regardless of Race/Stage Of Liver Disease
Oct
Hepatitis C Short-Course Telaprevir Equal to Full-Course in Some Patients With HCV
Vertex Announces Start of/Phase 3b Study of Twice-Daily Telaprevir in People Not Treated Previously for HCV
Oct 25
STAT-C Drugs From HCV Advocate .
STAT-C drugs block specific steps of the viral lifecycle. For example, HCV protease inhibitors (such as telaprevir and boceprevir) interfere with an enzyme encoded by the NS3/4A gene that processes proteins before they can be assembled into new virions (virus particles). HCV polymerase inhibitors disrupt the action of another enzyme, encoded by the NS5B gene, that copies viral genetic material. ,
The HCV lifecycle and how drugs work is explained more fully in the
December 2009 HCV Advocate.
Vertex Edges Merck In First Round of Hepatitis C Fight
Oct 1 2010
By ROBERT LANGRETH
New details of studies of rival hepatitis C drugs from Merck and Vertex Pharmaceuticals were released today in advance of a crucial upcoming meeting of liver specialists at the end of the month in Boston. The drugs, so-called hepatitis C protease inhibitors, represent the first class of agents that directly target the hepatitis C virus. Both have substantially boosted the cure rate in big trials, raising excitement among hepatitis c specialists.
While the drugs haven’t been compared directly, it appears that Vertex’s telaprevir drug is is a nudge better. Unless differences in tolerability and side effects emerge, if both drugs are approved, doctors may look at the data and go with the Vertex drug first because its cure rates appear to be a few percentage points higher.
Continue Reading..............
Vertex’s Telaprevir Excels in Treatment-Experienced HCV Population
Guidance for Industry: Chronic Hepatitis C Virus Infection: Developing Direct- Acting Antiviral Agents for Treatment
(U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) September 2010 Clinical Antimicrobial)
Boosting its chances of approval, Vertex’s telaprevir showed a 65 percent viral cure rate among the hardest-to-treat hepatitis C (HCV) patients, the company announced Tuesday. With the news, telaprevir and Merck’s competing boceprevir are both on pace for approval sometime next year. Both Merck, which released positive Phase III results in a same treatment-failure population last month for boceprevir, and Vertex expect to have their NDAs completed and submitted to the FDA by year’s end.
From FDA News