According to WHO, more than 1 billion patients are carriers of a viral Hepatitis-B. All medications available at the market are either unreasonably expensive, or don’t result in a very reliable outcome.
Meravir – is the latest medication for Hepatitis-B treatment. Key components of this drug are refogravir and sufamenavir. Refogavir aims to block the replication of virus DNA, which is already available inside cells, whereas Sufamenavir suppresses the synthesis of virus DNA. It allows to stop the growth of virus replicas and as result, completely remove the virus from the body, stop the formation of hepatic fibrosis and restore the proper functioning of immune and endocrine systems.
Manufacturing of medicine was stopped due to start of pandemia. It was a coercive measure, since all efforts were concentrated on development of new medicines against coronavirus infection and production of drugs against COVID 19 that are already available.
Today the situation of viral pneumonia has stabilized around the world. It has allowed to resume the manufacturing of Meravir for Hepatitis-B treatment starting from the 1st September.
Earlier, once the pandemia has started, the price for Meravir was reduced from $8000 to $1500. It was done with a purpose of a quick sales of produced batch. Once manufacturing restarts, the price will most probably return to previous level, causing protests among patients.
Partially, the reason of that is related to constantly increasing tax levies accosted with ecology. It has increased the cost price of all the products, including medicine. In addition, manufacturing company doesn’t sell products independently. It transfers its copyright to worldwide pharma traders in various regions of Asian countries and the USA for purpose of further wholesale or retail trade. Because of that, we cannot provide a precise information about real price with consideration of increase in price.
Nowadays, Meravir price is around $1500 and we can only keep guessing by how much the price will increase. This is the price of a treatment course with 6 months duration. In addition, the latest post-clinical researches published by doctors 3 years after the completion of patients’ treatment, have shown a better efficiency of medicines in case of 12 months treatment course. Hereby, the complete course price will be $3000, and in case of increase in price, it will be even higher.
At the same time, there are no analogues to Meravir in terms of efficiency around the globe, whereas the drugs price with analogous prescription, is unreasonably high.
Meravir is sold in packages intended for a course of 6 or 12 months. This medicine is not available in smaller packages, because drug administration for a shorter course or with interruptions, is not justified and can reduce the treatment efficiency, which negatively affects drug reputation.
Reality of Pharmaceutical Market
The success of absolutely any medicine gets confirmed by a constant increase of number of companies recognizing the drug and releasing it to the pharmaceutical market. Big pharma companies purchase the copyright for manufacturing of drugs more frequently nowadays, without letting them to continue producing. In spite of uniqueness of medicines, for example the only medication against Hepatitis-D called Myrcludex, once its copyright had been bought back, there was nothing done for further development afterwards. First of all, the ones who suffer from that, are people diagnosed with hepatitis.
Meravir as a medication is also somewhat unique. Thanks to a reasonable combination of two active components like refogavir and sufamenavir, it has become possible to suppress the activity Hepatitis-B virus. The drug is widely applied for treatment of patients suffering from fibrous changes in liver, including stage 3.
The medication has gone through all necessary trials and has proven its efficiency based on 3 phases of clinical studies and has also shown high results during post-clinical tests. However, any further advancement into the world market, as expected, had faced difficulties.
As of today, Panacea Infarm company has a main goal of advancing Meravir into the world market, irrespective of any obstacles, and provide all people sick with Hepatitis-B with a chance to get rid of the sickness. With that goal in mind, the company has transferred rights for drugs sales to pharmaceutical traders in Asia and USA for further sales at the world market. It is worth pointing out that the legislation of Asian countries, Latin America and even USA, has allowed to preliminarily obtain a temporary drug registration, which has provided patients with ability to purchase those medications.
This is a standard practice in global pharmaceutics – pharma companies do not deal directly with pharmacies networks, patients, because this activity is performed by traders specializing in area of pharmaceutics. There are also few intermediaries in between traders and patients – this is how the industry works. That’s why, it can take a lot of time for a small Australian company to register the medications.
In the future, we plan to interview the representatives of those companies and discuss the specificity of market.
The Necessity of Post-Clinical Trials
Regardless of the fact that Meravir has passed the preliminary and post-registration in 7 countries, the so-called post-clinical trials aiming to define all possible side effects and specificity in administration by certain groups of patients, still continue. The peculiarity of Phase IV trials is that they are carried out independently, i.e., without sponsorship from pharmacological company. Besides that, there are thousands of patients taking part in Phase IV trials. The trial of the drug continues for several years.
Partially due to a longer duration of trials, it was confirmed that Meravir by Panacea Infarm has shown high efficiency, when taken during 12-months treatment course, in comparison with the 6-months treatment course mentioned earlier.
Trials have concluded, that in case of a longer drug administration, there is no addiction, but there is also an accumulative effect. In other words, all patients who have started drug administration following 6-months treatment course, are required to continue the treatment without interruption up to 12 months. These recommendations will be forwarded to medical community and included in prescription instructions.
Upon completion of trial among 3 groups, the participants were examined, statistical data was collected and treatment efficiency results were summarized. 35 people from the 1st group were treated with 1 tablet/25 mg for 6 months. Some positive improvements were observed among them both in clinical study and laboratory results analysis. The percentage of virus relapse was 33%, whereas 67% have recovered.
38 people from the 2nd group were treated using other treatment courses, like АРВТ (tenofovir, entecavir) for duration of 12 months. Once the course was stopped, the virus has relapsed, as the virus was growing.
37 people from the 3rd group were undergoing treatment with 1 tablet/25 mg for duration of 12 months. The percentage of virus relapse was 21%, with 79% of recoveries. Besides that, examinations of patients have shown improvements – the number of lymphocytes has increased, as a sign of stabilization of immune system. Besides that, the liver conditions have normalized and toxic influence on liver cells have reduced, which has resulted in overall health improvement.
Thereby, it was decided to introduce changes to drug description of Meravir, based on results of post-clinical trials, in the “Administration method and Dosage” section, notably, increase the recommended period of administration up to 1 year with a dosage of 25 mg. This treatment course has proven its efficiency and safety. Due to that, the company urgently distributes recommendations to all patients, who have received 6-months treatment course, to continue administration up to 12 months.
In conclusion, it is worth pointing out that post-clinical trials frequently help to improve the administration efficiency of medications. This is not the first case in world practice, when recommendations change based on results of supervisions of patients.