New YORK (Reuters Health) – manage Peginterferon and ribavirin for 24 weeks after completing treatment combined with telaprevir is as effective as the regime of 48 weeks to cure chronic infection by the virus of hepatitis C (HCV), according to a new Studio.
Reduce the duration of treatment reduces the risk of adverse effects, but only in patients who respond quickly to the initial phase of treatment, publishes a team in the New England Journal of Medicine internet Edition.
“In our study, two-thirds (65 percent) patients were candidates to receive shorter therapy due to its extended rapid viral response.” “Were they could have indicated Peginterferon and ribavirin for 24 weeks”, said the lead author, Dr. Kenneth Sherman, of the school of Medicine of the University of Cincinnati.
The study of non-inferiority was designed to confirm that patients with the fourth and twelfth weeks not detectable HCV RNA evolved not worse with an abbreviated system of therapy with Peginterferon and Ribavirin, combined in a first stage with telaprevir.
Vertex Pharmaceutical
and Tibotec funded study ILLUMINATE. The administration of food and medicines of United States (FDA for its acronym in English) approved telaprevir may last.
The study began with the selection of volunteers from Belgium, the Netherlands and the United States genotype 1 HCV carriers. None had been treated prior.
A 540 was told to take 12 weeks of treatment with telaprevir (750 mg every eight hours), Peginterferon alfa-2a (180 mcg per week) and Ribavirin (1,000-1,200 mg per day), most combination of Peginterferon and Ribavirin during other 12 weeks.
One hundred patients left the initial phase of treatment (including 12 which made him by virological failure, 62 by adverse effects and 12 because they refused to continue the treatment or withdrawn consent).
Of 440 volunteers who continued in the study, 322 were extended rapid virological response: HCV RNA kept undetectable in the blood at 20 weeks. Randomly, stated them stopping treatment to reach 24 weeks or continue it another 24 weeks.
92 Percent of the 162 with extended rapid virological response ending treatment at 24 weeks was still free of virus to 48 weeks.
The 88 percent of the 160 remaining, who continued therapy with Peginterferon and ribavirin for another 24 weeks, remained a virological response sustained at 48 weeks. In this group, 41 left 24 weeks of treatment.
On the other hand, 64 percent of 118 patients without rapid response with other 24 weeks of treatment, had a sustained virological response. Thirty-nine of them suspended treatment.
Total, 72 percent responded quickly to the regime of three drugs to the fourth week. 12 Weeks, 65 per cent remained traces of the virus in the body
In the essay ILLUMINATE, 18 per cent of volunteers treatment was withdrawn by the adverse effects: anaemia by 39 per cent of the patients (by 6 per cent of the cases was serious and 32 participants needed transfusions) and rash in 37 percent of patients (5 per cent was serious).
Most of the cases of rash appeared in the first eight weeks of treatment.
Serious adverse effects were more common in the group treated for 48 weeks with Peginterferon and Ribavirin. (The rate was 10 percent, compared with 2 percent of patients with limited treatment).
Fatigue was the most common secondary effect (68 percent), followed by pruritus (51 percent), nausea (47 percent), anemia (39 percent), headaches (38 percent), insomnia (32 per cent), diarrhoea (28 percent) and disease type influenza (26 percent), it was reported the team.
The traditional 48 weeks of Peginterferon and Ribavirin therapy costs about $30,000, said Sherman. But the telaprevir is more expensive. “I saw figures of $49,000,” indicated.
“This is a lot of money for a short treatment, but must be compared with the costs to society of hepatitis C without trying, in which even a liver transplant could cost hundreds of thousands of dollars, not to mention previous transplant associated medical costs,” finished Sherman.
Source: New England Journal of Medicine, September 2011
