Hepatitis C: victory is close
A method of absolute cure for hepatitis C has been found
The report on the test results was published on November 5 in The Lancet (Lawitz et al., Sofosbuvir and ledipasvir fixed-dose combination with and without ribavirin in treatment-naive and previously treated patients with genotype 1 hepatitis C virus infection (LONESTAR): an open-label, randomized, phase 2 trial).
Currently, the standard treatment for hepatitis C is combined antiviral therapy, including injections of pegylated alpha interferon and oral ribavirin. Its effectiveness is approximately 75 percent after a year of treatment. However, this method has serious side effects, primarily due to alpha interferon - anemia, leukopenia, heart failure and depression, which pushes specialists to search for alternatives.
In April 2013, it was reported about the successful completion of the third (last) phase of clinical trials of sofosbuvir, which suppresses the replication of hepatitis C virus, belonging to the NS5B class of RNA polymerase inhibitors, in various combinations and against different genotypes of the virus. Good results were obtained by combining sofosbuvir and ribavirin with respect to less common genotypes 2 and 3, and a combination of the same drugs plus peginterferon-alpha with respect to the most common genotype 1. In August, it became known about the successful results of the second phase of clinical trials of complex therapy with sofosbuvir and ribavirin, already without interferon, in patients whose blood contains genotype 1 virus. This mode showed 70 percent effectiveness.
This time, the activity of a combination of sofosbuvir and another experimental antiviral drug, ledipasvir, which is an inhibitor of the NS5A protein that plays a key role in viral replication, was investigated against the genotype 1 virus. One hundred adult patients were selected to participate in the trials, sixty of whom had not previously received treatment, and forty had failed previous therapy with protease inhibitors. At the same time, in the last group, 22 people had compensated cirrhosis of the liver.
During the trials, participants received therapy in various regimens, some of them – 400 milligrams of sofosbuvir and 90 milligrams of ledispavir orally once a day, and some of them had ribavirin added to this combination. The duration of the courses varied from 8 to 12 weeks.
As a result, a sustained virological response (absence of virus RNA in the blood) after 12 weeks from the start of therapy was recorded in an average of 97 percent of participants. In the groups taking ribavirin in addition to sofosbuvir and ledispavir, the cure was one hundred percent. However, in these groups, the greatest number of episodes of side effects were also noted, which experts associate with ribavirin. In general, about half of the participants had no side effects at all. The results were confirmed 24 weeks after the start of therapy.
In the course of further clinical trials, it is planned to determine the optimal duration of the course of treatment and evaluate the contribution of ribavirin to its effectiveness.
At the end of October, the expert panel of the US Food and Drug Administration (FDA) recommended that the agency approve sofosbuvir for use in the country. Ledispavir is still at the stage of clinical trials.
Portal "Eternal youth" http://vechnayamolodost.ru06.11.2013