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New two part video from Melissa Palmer, M.D. on Telaprevir (Vertex Pharmaceuticals) & Boceprevir (Merck), the new protease inhibitor treatments for hepatitis C (HCV).
From The AIDS Beacon
This article is first in a two-part series that will discuss the benefits and drawbacks of two drugs, boceprevir and telaprevir, which are being developed for hepatitis C. Part 1 discusses the efficacy of the two drugs in clinical trials. Part 2 discusses the complications and side effects for each drug
FDA Approves Telaprevir for HCV
Emma Hitt, PhD
May 23, 2011 — The US Food and Drug Administration (FDA) has approved telaprevir (Incivek, Vertex) for the treatment of hepatitis C virus (HCV) infection. The approval comes 1 week after approval of boceprevir (Victrelis, Merck), also for HCV, and is the second drug to be approved for HCV in 20 years.should receive FDA approval for this indication.
Telaprevir is approved for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin, in patients aged 18 years and older with compensated liver disease, including cirrhosis, who are treatment-naive or who have been previously treated with interferon-based treatment.
The FDA's approval today was based on the Antiviral Drugs Advisory Committee's unanimous 18 to 0 vote on April 28 recommending that telaprevir
Trial data were collected from three phase 3 randomized trials, conducted in about 2250 previously treated and untreated patients (1797 patients who received telaprevir combination treatment and 493 who received peginterferon alfa and ribavirin alone). Two of the trials were in treatment-naive patients and 1 was in previously treated patients (relapsers, partial responders, and null responders).
In the studies, telaprevir was administered at a dose of 750 mg every 8 hours; the peginterferon alfa-2a dose was 180 µg/week, and the ribavirin dose was 1000 mg/d in patients weighing less than 75 kg or 1200 mg/d in patients weighing 75 kg or more.
Compared with the control group, receiving ribavirin plus pegylated interferon, the patients who also received telaprevir had a significantly higher rate of sustained virologic response of about 80% or more. The sustained virologic response rate for patients treated with telaprevir across all studies, and across all patient groups, was 20% to 45% higher than the current standard of care.
"Major Step Forward"
"With the approval of [telaprevir], there are now 2 important new treatment options for hepatitis C that offer a greater chance at a cure for some patients with this serious condition," Edward Cox, MD, MPH, director, Office of Antimicrobial Products in FDA's Center for Drug Evaluation and Research, said in an agency news release. "The availability of new therapies that significantly increase responses while potentially decreasing the overall duration of treatment is a major step forward in the battle against chronic hepatitis C infection."
It may be possible to shorten telaprevir treatment from 48 weeks to 24 weeks in most patients, the FDA news release states. Among previously untreated patients, 60% achieved an early response and received only 24 weeks of treatment (compared to the standard of care of 48 weeks). The sustained virologic response for these patients was 90%.
Common adverse events with telaprevir when used in combination with ribavirin and pegylated interferon include anemia, nausea, fatigue, headache, diarrhea, pruritus, and anal or rectal irritation and pain.
"Telaprevir will likely be very well received as a treatment option in addition to ribavirin and peginterferon alfa for patients with genotype 1 HCV previously unresponsive to the standard of care," said McKenzie C. Ferguson, PharmD, assistant professor of pharmacy practice at the Drug Information & Wellness Center, Southern Illinois University, Edwardsville, Illinois.
"Additionally, studies in previously untreated patients have demonstrated that we can now treat genotype 1 patients for shorter durations (based on early virologic response) to achieve sustained virologic response or 'cure,'" she told Medscape Medical News. "This is a dramatic improvement as many of the challenges to treating HCV is battling adherence issues and adverse drug effects for long durations of treatment."
Dr. Ferguson said she believes both drugs will show similar therapeutic effect profiles, but as use of these agents increases, more insight will be available regarding which to use in certain patients. "At this point, serious skin reactions with telaprevir are a concern and have not been observed to the same extent with boceprevir," she said.
Both telaprevir and boceprevir interfere with the ability of the HCV to replicate by inhibiting a key viral enzyme (NS3/4A serine protease).
Authors and Disclosures
Journalist
Emma Hitt, PhD
Emma Hitt is a freelance editor and writer for Medscape.
Disclosure: Emma Hitt, PhD, has disclosed no relevant financial relationships.
Dr. Hitt does not intend to discuss off-label uses of drugs, mechanical devices, biologics, or diagnostics not approved by the FDA for use in the United States.
Dr. Hitt does not intend to discuss investigational drugs, mechanical devices, biologics, or diagnostics not approved by the FDA for use in the United States.
FDA Okays Second Hepatitis C Antiviral
The Food and Drug Administration May 23 approved the protease inhibitor telaprevir to treat adults with genotype 1 chronic hepatitis C, in combination with standard therapy – a decision that comes less than 2 weeks after the agency okayed another protease inhibitor, boceprevir, for hepatitis C combination treatment.
"The availability of new therapies that significantly increase responses while potentially decreasing the overall duration of treatment is a major step forward in the battle against chronic hepatitis C infection," said Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, in a statement.
Telaprevir’s approved indication is for treatment (in combination with peginterferon alfa and ribavirin) of genotype 1 chronic hepatitis C in adults "with compensated liver disease, including cirrhosis, who are [treatment naive] or who have been previously treated with interferon-based treatment, including prior null responders, partial responders, and relapsers."
At a meeting in April, the FDA’s antiviral drugs advisory panel unanimously supported the approval of telaprevir.
The FDA based its approval decision on the results of three phase III studies comparing treatment with peginterferon alfa and ribavirin (standard treatment) alone or in combination with telaprevir in about 2,250 treatment-naive and treatment-experienced adults.
The sustained virologic response (SVR) rate was 20%-45% higher among patients on telaprevir plus standard treatment, compared with those on standard treatment, according to the FDA statement announcing the approval.
Fewer than half of the patients responded to standard treatment with peginterferon alfa and ribavirin, which is administered for 48 weeks. However, the telaprevir studies indicated that treatment with telaprevir can be shortened to 24 weeks, "in most patients," according to the FDA, which noted that 60% of previously untreated patients achieved an early response after 24 weeks of treatment, with an SVR of 90%.
The recommended dosing is 750 mg of telaprevir taken three times a day, with food. It is administered with peginterferon alfa and ribavirin for 12 weeks, "followed by a response-guided regimen of either 12 or 36 additional weeks of peginterferon alfa and ribavirin depending on viral response and prior response status," according to the label.
The most commonly reported side effects associated with telaprevir in clinical trials included rash (which can be severe and treatment limiting), anemia, nausea, fatigue, headache, diarrhea, pruritus, and anal or rectal irritation and pain. Rash can be serious and may require stopping treatment with telaprevir or all three drugs, the FDA statement said.
Vertex Pharmaceuticals will market telaprevir as Incivek. Merck will market boceprevir as Victrelis, which the FDA approved May 13.
Keith Alcorn
Published: 23 May 2011
The US Food Administration has approved a new hepatitis C drug telaprevir (Incivek), the agency announced today.
Telaprevir is a direct-acting antiviral drug (an HCV protease inhibitor), licensed for use in combination with the current standard treatment, pegylated interferon and ribavirin.
The drug has been developed by Vertex, which will market the drug in the United States.
Telaprevir is the second HCV protease inhibitor to be approved this month. The US Food and Drug Administration approved boceprevir (Victrelis) on may 13.
The safety and effectiveness of telaprevir was evaluated in three phase 3 clinical trials with about 2,250 adult patients who were previously untreated, or who had received prior therapy. In all studies patients also received the drug with standard of care. In previously untreated patients, 79 percent of those receiving telaprevir experienced a sustained virologic response (i.e. the infection was no longer detected in the blood 24 weeks after stopping treatment) compared to standard treatment alone.
The sustained virologic response for patients treated with telaprevir across all studies, and across all patient groups, was between 20 and 45 percent higher than current standard of care.
The studies indicate that hepatitis C treatment can be shortened from 48 weeks to 24 weeks in most patients when telaprevir is used in the first 12 weeks. Sixty percent of previously untreated patients achieved an early response and received only 24 weeks of treatment (compared to the standard of care of 48 weeks). The sustained virologic response for these patients was 90 percent.
Telprevir is dosed as two pills taken three times a day with food. It should be taken for the first 12 weeks in combination with pegylated interferon and ribavirin. Most people with a good early response to the combination regimen at 12 weeks can be treated for 24 weeks rather than the recommended 48 weeks of treatment with the standard of care.
The most commonly reported side effects in patients receiving telaprevir in combination with pegylated interferon and ribavirin include rash, low red blood cell count (anemia), nausea, fatigue, headache, diarrhea, itching (pruritus), and anal or rectal irritation and pain.
Rash can be serious and can require stopping Incivek or all three drugs in the treatment regimen.
Telaprevir is expected to receive European Union marketing approval in the second half of 2011.
From; In Pharm
The FDA has approved Johnson & Johnson/Vertex’s new oral hepatitis C drug Incivek.
Incivek (telaprevir), a protease inhibitor, is now licenced in the US for use in patients with genotype 1 chronic hepatitis C with compensated liver disease, including cirrhosis.
Incivek (telaprevir), a protease inhibitor, is now licenced in the US for use in patients with genotype 1 chronic hepatitis C with compensated liver disease, including cirrhosis.
It is approved as a first line treatment, and for previously treated patients who did not achieve a viral cure.
The decision is based on impressive phase III results for the drug that saw 79% of patients using Incivek achieving a viral response - which is tantamount to a cure - compared to just 46% of those on standard treatments.
Vertex said it hoped for a European approval, where its partner Johnson & Johnson holds the marketing rights, by the end of the year.
The drug has been tipped to be a blockbuster as it has shown a higher cure rate than older anti-viral treatments.
Matthew Emmens, chief executive of Vertex, said: “Today marks a turning point in the fight against hepatitis C, particularly for people who have been living with this silent disease for decades, hoping for a better chance of a viral cure.”
Rash and anaemia were the most serious side effects associated with the drug, with the most common side effects including fatigue, itching, nausea, diarrhea, vomiting, anal or rectal problems, and taste changes.
The news comes in the same month that its rival Merck received approval for its oral hep C drug Victrelis (boceprevir) for a similar licence, which is also expected to generate blockbuster sales.
Current hepatitis C treatments have seen only limited success and have not proved powerful enough to help a majority of those infected.
The two new and more powerful oral treatments herald the next generation of drugs to fight the disease.
Edward Cox, director of the office of antimicrobial products in FDA’s Center for Drug Evaluation and Research, said: “With the approval of Incivek, there are now two important new treatment options for hepatitis C that offer a greater chance at a cure for some patients with this serious condition.”
The decision was widely expected after an FDA advisory panel voted unanimously to recommend the drug last month.
Incivek is given for 12 weeks in combination with current standard treatments pegylated-interferon and ribavirin (Roche’s Pegasys and Copegus), after which patients stop taking the drug and continue treatment with pegylated-interferon and ribavirin alone.
Vertex said Incivek would be launched in the US by the end of the week.
Ben Adams
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