Duke Health

Those suffering from Hepatitis C may recover from the disease in a much quicker manner. Patients who are willing to give the hepatitis C treatment another chance, may benefit if the investigational drug telaprevir is added to the usual treatment, reports a study being conducted at Duke Clinical Research Institute (DCRI). It is believed that out of the patients who were retreated with telaprevir, almost half of them were cured. While only 14 percent of those who were treated normally, were cured.

Normal treatment for hepatitis C takes about 48 weeks and prescribes a combination of peginterferon alfa-2a (Pegasys) and the antiviral agent ribavirin. The treatment appears to cure atleast 40 percent of people who undergo it, while those who fail to respond, are left with no choice but to repeat the procedure.

Telaprevir is a protease inhibitor that works by blocking an enzyme that is used by hepatitis C to replicate itself. The study proposes that this drug may help improve the chances of getting cured for many patients. The findings of the study have been deduced from a DCRI-coordinated, multinational study on 453 patients who failed to respond to the hepatitis C treatment. All patients reported of the most common form of virus, genotype 1, which seemingly is the toughest form of hepatitis to cure.

Scientists randomly segregated the patients into four distinct groups. All subjects were treated with either peginterferon or peginterferon combined with ribavirin for 24 or 48 weeks. Scientists added the experimental drug telaprevir to three of the regimens for a duration of 21 or 24 weeks. Patients in the fourth stage of the study were prescribed a placebo along with peginterferon and ribavirin.

The team then measured the amount of virus in the patients’ blood at various points during the therapy. Following on they checked on the viral load six months after the last treatment session. Patients who did not have any detectable virus in their body, were assumed to have been cured. Scientists discovered that by adding telaprevir to the treatment, enhanced cure rates across the board considerably.

John McHutchison, MD, associate director for research for the DCRI and the lead author of the study said that, “Fifty-two percent of patients who had originally failed to respond to standard treatment were cured of their disease when we added telaprevir to a retreatment regimen consisting of peginterferon alfa-2a and ribavirin. This is a major development in the field and may represent the single most significant efficacy finding in the treatment of prior non-responders.”

McHutchison also indicated that almost 24 percent of the patients who received telaprevir and peginterferon without ribavirin were virus-free at the end of 6 months post-treatment period. This may establish the fact that ribavirin is a key component in the treatment process. On the other hand only 14 percent of those who had received the regular treatment for the disease were found virus-free after six months. Patients in the latter group were given the telaprevir, peginterferon and ribavirin combination treatment.

Further analysis also revealed an association between the patient’s prior treatment experience with reaction towards retreatment. Patients who had responded to the regular treatment but relapsed, gave a very sustained response to the drug in comparison with the original non-responders. However it was noticed that telaprevir did have certain side-effects. About half the patients reported of rashes and approximately 5 percent patients had to stop the treatment in totality as the rash got severe. It was also noted that almost 15 percent patients who were undergoing the telaprevir-based treatment were more likely to stop treatment when compared to those receiving normal treatment.

“While it is true that patients receiving all three drugs were more likely to experience side effects, especially rash and anemia, the benefit of the regimen can be substantial,” said McHutchison. “Adding telaprevir to standard treatment for hepatitis C is very helpful to large numbers of patients who originally failed to fully respond to previous treatment.”

The team is still in the process of conducting the third phase of the study, to investigate telaprevir retreatment strategies for patients who didn’t respond to the initial therapy.

The study was published in the New England Journal of Medicine.