The regimen for the boceprevir-treated patients consisted of a four-week lead-in phase of pegylated interferon and ribavirin after which boceprevir was added. Treatment lasted for a further 44 weeks. All patients had been treated previously. Five per cent in the boceprevir group and ten per cent in the telaprevir group were prior null responders.
Multivariate analysis showed that prior relapsers were twice as likely to achieve SVR12 when compared to partial or null responders odds ratio 2. Multivariate analysis showed that patients with genotype 1b were almost twice as likely to achieve SVR 12 odds ratio 1.
Five per cent of people taking telaprevir developed grade 3 serious rash and two patients suffered severe cutaneous adverse reaction SCAR , a potentially life-threatening form of rash which produces systemic symptoms. There was a 2. Causes of death were not reported. Three patients died of sepsis blood poisoning and another one of pneumonia lung inflammation. Three further patients died because of variceal bleeding, or encephalopathy, or pulmonary neoplasia.
In the boceprevir group there were three deaths, one due to pneumonia, another to sepsis and one to aneurysmal bleeding. Liver decompensation was diagnosed in 5. Erythropoietin EPO or blood transfusions were frequently required because of anemia. Among those receiving boceprevir, patients Outcomes were broadly similar to those observed among the sub-group of patients with advanced fibrosis or cirrhosis enrolled in the phase 3 studies that led to the approval of these protease inhibitors.
Further data on the use of telaprevir and boceprevir in people with liver cirrhosis were reported from an Austrian cohort. Karoline Rutter of the Division of Gastroenterology and Hepatology at the Medical University of Vienna presented data on the safety and efficacy of triple therapy with boceprevir or telaprevir plus pegylated interferon and ribavirin in patients.
Sixty-six people with F3 or F4 fibrosis received boceprevir and 65 received telaprevir. Of the people with F3 or F4 fibrosis, 37 achieved a sustained virologic response. Twenty-four cases of post-treatment virologic relapse occurred in this group. Thirty study participants are still on treatment or have not completed 12 weeks of post-treatment follow-up.
Twenty-seven people discontinued due to adverse events, of whom six nevertheless achieved a sustained virologic response. Sign In or Register. Share Telaprevir Incivek Discontinued. This treatment has been discontinued. Table of Contents. Drug Summary Although telaprevir was a promising direct-acting antiviral agent that had impact in the hepatitis C treatment field during to , it was subsequently replaced by newer direct-acting antiviral agents that were more effective, better tolerated, and more convenient.
Based on the dwindling role of telaprevir after newer direct-acting antiviral agents were approved, Vertex pharmaceuticals discontinued the sales and distribution of telaprevir in the United States in October Telaprevir does have some current importance since persons who previously failed a telaprevir-based regimen may have developed resistant associated variants, which could potentially impact subsequent therapy. Adverse Effects The most significant adverse effects reported in the main registration trials and in post-marketing experience were rash, anorectal complaints, and anemia.
In most cases, the rash that develops is eczematous or maculopapular in character and mild to moderate in severity; the rash is typically manageable with good skin care and topical emollients or corticosteroids. Teleprevir has a black box warning for fatal and non-fatal serious skin reactions.
FDA on May 23, for the treatment of adults with chronic hepatitis C. Telaprevir Incivek is no longer manufactured in the United States. Indications The following list summarizes the key points related to telaprevir indications. Telaprevir is approved for use in combination with peginterferon and ribavirin to treat adults with genotype 1 chronic hepatitis C infection and compensated liver disease.
Telaprevir must be combined with two older drugs: pegylated interferon, which stimulates the body's own immune response against the virus, and ribavirin, which improves the effectiveness of interferon.
Telaprevir is indicated for use by adults with chronic hepatitis C, meaning infection lasting more than six months. It is approved for people with HCV genotype 1, which is the most common type in Europe and considered the hardest to treat. It is not approved and should not be used to treat other HCV genotypes. Telaprevir can be used by people being treated for hepatitis C for the first time known as 'treatment-naive' and for retreatment of people who were not cured with previous interferon-based therapy.
Response rates and side-effects are similar to those of HIV-negative people, but telaprevir can interact with some HIV drugs. People with HIV and HCV co-infection who want to take telaprevir should do so under the care of a doctor who has experience treating both infections.
Telaprevir can be used by people with all stages of compensated liver disease including cirrhosis. However, it works better for people with less advanced liver damage. Also, people with cirrhosis who take telaprevir may experience more serious side-effects. Telaprevir triple therapy can be dangerous and therefore should not be used by people with decompensated liver disease, or liver failure. Telaprevir is a pill that may be taken as either three tablets twice daily or two tablets three times daily.
It should be taken with food. Telaprevir must be used with weekly pegylated interferon injections and twice-daily ribavirin pills. Telaprevir is not effective if taken alone, and this can lead to drug resistance. All three drugs are taken together for 12 weeks. Then interferon and ribavirin alone are taken for an additional 12 or 36 weeks, depending on early response, previous treatment history and extent of liver damage.
This is known as 'response-guided therapy'. Telaprevir works better for some people than for others. Several factors predict how well someone will respond. Telaprevir is only approved for genotype 1 hepatitis C. It is not proven effective against genotypes 2, 3 or 4. Different direct-acting antivirals work better against these other genotypes.
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