Due to a requirement to confirm the efficacy, a medication to treat Hepatitis-B called Meravir, is undergoing new post-clinical researches. As result, efficacy turned out to be high, however it requires a longer treatment duration.
Be reminded, that Meravir represents a unique medication to treat Hepatitis-B, which includes 2 active components that suppress the ability of a virus to divide inside cells. Meravir is prescribed to patients suffering from Hepatitis-B with fibrosis below stage 3. The only limitation is Hepatitis-D and liver cirrhosis.
Although Meravir has already undergone a preliminary post-registration in 7 countries, so-called post-clinical researches are still ongoing and target the detection of possible side effects and specificity of administration among certain groups of patients. Specificity of Phase IV of research is the fact that it is carried out independently, i.e., not sponsored by a pharmacological company. Besides that, there are more than one thousand of patients taking part in Phase IV. The medication trial itself continues for several years.
Partly due to a longer trial period, it was confirmed that Meravir by Panacea Infarm company has shown a high efficacy with 12-months administration period in comparison with a previously recommended half-year administration period.
The researches have confirmed that in case of a longer administration of medication, there is no addiction, but at the same time there is an accumulation effect. In other words, patients who have started 6-months administration scheme, are required to continue the treatment up to 12 months without interruption. These recommendations will be forwarded to medical society and included in administration instructions.
After completion of Stage 3 of research, all participants have been examined, statistical data has been collected and treatment efficacy results have been concluded. The first group of 35 participants was receiving 1 tablet/25 mg for a duration of half year. Positive improvements were observed among them both in clinical findings and results of laboratory trials. The percentage of virus recurrence was 33% and 67% of recovery.
The second group of 38 participants was receiving different schemes of APBT treatment (tenofovir, etacovir) during 12 months, and after cancellation of treatment, the virus has returned with growth of viral load.
The third group of 37 participants was receiving 1 tablet/25 mg for a duration of 12 months. The percentage of virus recurrence was 21% and 79% of recovery. Besides that, the examinations have shown improvements – the number of lymphocytes has increased, confirming the stabilization of immune system, and besides that the liver conditions have improved, while toxic impact on cells of an organ has reduced, which had positive effect on overall wellbeing.
Likewise, based on results of post-clinical researches, it was concluded to include changes in Meravir drug instructions inside the “Dosage and Administration” section – specifically, to increase the recommended treatment period up to 1 year with 25mg dosage. This scheme has proven its efficacy and safety. Due to that, the company urgently distributes the recommendations to extend the treatment up to 12 months, to all patients undergoing a 6-months treatment.
It is worth pointing out that starting from 1st of September it is planned to revive drug manufacturing. Earlier, the process was stopped due to pandemia. There is no final decision with regards to price yet.
In conclusion, post-clinical researches frequently help to improve the efficacy of drugs administration. This is not the first case in world practice, when recommendations are changed based on results of patients supervision and observation.