The liver is a kind of cleansing filter for the human body. The state of this body affects the functioning of many systems and the quality of life of a person as a whole. One of the most serious liver lesions is hepatitis C. Currently, many drugs have been developed to combat this disease. One of the most effective means is considered (as confirmed by medical reviews) Sofosbuvir.
Indications for use
In general, sofosbuvir is called the active substance in tablets, and the brand itself has the trade name "Sovaldi". Thus, we can say that this medicine is a cheaper substitute - the generic "Sofosbuvir", reviews of which describe the drug as one of the most effective drugs for the treatment of hepatitis C. This is its main area of application.
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The main substance, sofosbuvir, is an inhibitor of the NS5B viral polymerase, that is, it suppresses the proliferation of the hepatitis C virus. However, most medical specialists do not recommend Sofosbuvir monotherapy (although this is, in principle, possible). But as the main active component of complex antiviral therapy, Sofosbuvir reviews have only a positive focus, characterizing it as a highly effective agent. According to clinical trials, the drug in tandem with other medicines showed excellent results in relation to the treatment of hepatitis C virus (genotypes 1, 2, 3).
The treatment with Sofosbuvir is positively characterized by the reviews of health workers not only in relation to patients who have never been treated by him, but also in relation to those who had previously received antiviral therapy with other drugs and who had recurred after treatment.
In addition to the above-described area of impact, Sofosbuvir, reviews of doctors and recommendations of the instructions allow the use in the treatment of patients suffering from cirrhosis.
Regarding the effectiveness of the drug in relation to co-infection of HIV and hepatitis (a fairly common situation), such information is currently not available, although the drug is indicated for use in such situations.
Contraindications
In the vast majority of cases, the drug itself and its generics were well tolerated by patients.
However, the drug for the treatment of hepatitis C "Sovaldi" (or "Sofosbuvir"), reviews of which are positive, like any modern highly effective medication, has certain contraindications for use.
Firstly, it is an individual hypersensitivity to the main and auxiliary components of the drug. Women of childbearing age should be careful when using it. In particular, if Sovaldi (Sofosbuvir) is prescribed in combination with Ribavirin and Interferon alfa (relevant for hepatitis genotypes 3, 4, 5, 6), pregnancy should be avoided in every possible way. It is also very undesirable to carry out treatment with these agents during pregnancy and during lactation.
Currently, no information is available on the impact of Sofosbuvir on human reproductive function. There is also no information about the safety and effectiveness of the medication in patients under 18 years of age.
Methods of application and duration of therapy
First, it is worth stipulating that antiviral therapy is permissible only for those medical specialists who have sufficient experience in treating patients with hepatitis C. The standard dosage regimen is 1 tablet (400 mg of active ingredient) during the day during any meal period. Since the tablets are bitter (such are those from those taking the medication), Sofosbuvir should be swallowed without chewing or breaking.
If the tablet has been taken and vomiting has begun within the next 2 hours, it is recommended that you take another 1 tablet. If vomiting develops after a period of time greater than 2 hours, an additional dose is not necessary.
If the next dose of the drug was missed for any reason (the delay is no more than 18 hours), it is recommended to take the missed dose, and then continue treatment at the usual time. If the delay exceeds 18 hours - take the next dose at the usual time.
Combination Therapy Methods
As components of complex therapy for the treatment of hepatitis C, along with Sofosbuvir, the appointment of Ribavirin, Interferon Alfa, Daclatasvir, Ledipasvir, Asunaprevir is practiced.
In general, the tandem Sofosbuvir + Daclatasvir is characterized by reviews of medical workers and patients as effective for the fight against hepatitis C genotypes 1,2,3.
Genotypes 4, 5, 6 are treated with the complex of medicines Sofosbuvir, Ribavirin and Interferon alfa. The standard therapeutic period is at least 12 weeks. In cases where patients with genotypes 1, 4, 5, 6 have contraindications for taking Interferon alfa or have established hypersensitivity to this substance, Sofosbuvir with Ribavirin is prescribed for use for 24 weeks.
The Ribavirin tandem with the Sofosbuvir preparation for the 2 genotype is also described by specialists as an optimally effective combination, which is prescribed for admission for a period of at least 12 weeks. The same two medicines, but for a period of at least 24 weeks, are used with the 3 genotype of viral hepatitis C.
Information on the effectiveness of complex therapy with Ribavirin and Interferon for the treatment of genotype 1 is not available.
In the event that the patient suffers from hepatocarcinoma and / or expects a liver transplant operation, Sofosbuvir in combination with Ribavirin is practiced for 48 weeks or until surgery for an organ transplant. This is important in order to prevent infection of the liver after transplantation.
Clinical studies have shown that the combined use of Sofosbuvir with other drugs can provide a stable positive virological response in 92% of cases of complex therapy in the treatment of hepatitis C.
Feasible side effects
In the process of conducting clinical trials, the drug was well tolerated by patients (such were their reviews). Sofosbuvir causes side effects in most cases when used in combination with Ribavirin and Interferon.
With the combination of Sofosbuvir and Ribavirin quite often (in more than 10% of cases), the hemoglobin concentration in the blood composition decreases and the level of bilirubin rises, the manifestation of fatigue, irritability and insomnia, nausea is possible.
Less often (in less than 10% of cases), this combination of medications provokes depression, anemia, rhinopharyngitis, impaired attention, dyspepsia, constipation and intestinal disorders, allergic skin manifestations (itching, rashes). Sometimes patients leave such reviews: Sofosbuvir, used in parallel with Ribavirin, caused hair loss and back pain, seizures, myalgia and asthenia.
If a complex of three drugs is used (Interferon alfa is added to the two above), very often (more than 10% of cases) there is a much wider list of adverse events. Here they talk about changes in the composition of the blood: this is a decrease in the number of lymphocytes, platelets and neutrophils, anemia, an increase in the level of bilirubin. From the gastrointestinal tract, the development of diarrhea, nausea, and vomiting is possible. In addition, Sofosbuvir (instructions, reviews of patients and health workers confirm) can provoke headaches and dizziness, cough, shortness of breath, skin itching and rashes, myalgia and joint pain. Often patients talk about fatigue, irritability, chills, fever.
Less often (from 1 to 10%), patients talk about fears and the development of depression, weight loss, memory and concentration abnormalities, and migraines. There is information about visual impairment, hair loss, the development of reflux and shortness of breath with increasing load. Sometimes patients talk about pain in the back and chest, cramps and asthenia.
What do you need to know?
If a patient has one or several negative factors - initially high viral load, progressive fibrosis, too dark skin, then Sofosbuvir treatment (expert reviews and instructions for use confirm) can be increased by up to 24 weeks. When conducting combination therapy, the effective dose of Ribavirin is selected in accordance with the patient’s body weight, that is, 75 kg of body weight require 1.2 g of medication. The entire volume of the drug is divided into two parts and taken with food.
It is not recommended to reduce the dosage of Sofosbuvir.
If the combined use of “Solfosbuvir” and “Interferon alfa” develops negative manifestations characteristic of the last drug, the dose of “Interferon” you need to reduce or completely stop taking this medication (detailed rules for reducing the dose or canceling the drug are available in special instructions).
They do exactly the same when the combination of Sofosbuvir and Ribavirin is used, and negative effects on the intake of the latter develop - the dose is reduced or Ribavirin is completely stopped. After the results of blood tests improve, it is permissible to try to resume taking Ribavirin, starting from 600 mg and gradually increasing to 800 mg. It is not recommended to increase the dose to the originally prescribed.
If you cancel one of the complex therapy medications, you must completely stop taking Sofosbuvir - the reviews of experts and instructions for use in this matter coincide.
Interaction with other substances
Health workers do not recommend patients to use other antiviral drugs (except those prescribed by the attending physician) at the same time that hepatitis is being treated in parallel with the drug in question. Sofosbuvir reviews of experts consider it possible to combine with something else only in cases where the expected benefits of a combination of medicines exceed the possible risk of developing unwanted effects.
There are also groups of drugs, the combined use of which with Sofosbuvir can significantly reduce its absorption (Sofosbuvir) in the intestines. Such drugs - from anticonvulsants - include Phenytoin, Phenobarbital, Carbamazepine, and Oxcarbazepine. The antimycobacterial group of medicines also contains the following drugs: Rifabutin, Rifampicin, Rifapentin. Of herbal supplements, St. John's wort can significantly reduce the absorption of Sofosbuvir. It is also not recommended to combine the drug with HIV protease inhibitors: Tipranavir, Ritonavir.
Special instructions
Only the attending physician has the right to choose a treatment regimen for hepatitis C and medications that will be prescribed for treatment: Ledipasvir, Asunaprevir, Sofosbuvir, Daklatasvir. Reviews from patients about all generics of Sovaldi are positive.
However, it should be borne in mind that for patients with severe forms of renal failure, the dose volume must be specially selected. There is no need to recalculate the dosage for those who suffer from mild to moderate degree of pathology. As for liver failure, there is no need for dose adjustment for patients with any degree of disease severity.
In the treatment of hepatitis C using combination therapy based on Sofosbuvir, it is not recommended to engage in activities that require high concentration of attention and the speed of psychomotor reactions.
Price range
The cost of branded medicine in Germany is from 18 to 20 thousand euros. Moreover, for its acquisition, even at such a price, a prescription from the attending doctor will be required. Such a high cost is due to the fact that the development company must recoup all of its costs for research, development and testing of the drug.
Generic medicines (cheaper brand analogues with an absolutely identical active ingredient) will cost much less to the consumer. These include Daclatasvir, Asunaprevir, Ledipasvir and Sofosbuvir. Customer reviews contain information about the high cost of these medicines, but we are not talking about tens of thousands of euros.
Starting in March 2015, according to the license of the development company, the release of Sofosbuvir began by the Indian pharmaceutical company Natko (naturally, with the permission of the Ministry of Health of India).
At present, in Russia it is realistic to purchase a package (28 tablets) of Sofosbuvir medicine through online stores at a price of 39,900 rubles (1 tablet will cost the consumer about 1800 rubles). This is not cheap, but the exact same packaging of the brand “Sovaldi” will require financial investments in the amount of 1,500,000 rubles, which is almost 35 times more expensive than the cost of any generic.
There is still no way to buy this medicine through pharmacy chains, because the process of certification of new medicines in Russia is quite lengthy.
Opinion of consumers and doctors
The drug was taken by patients with different genotypes of hepatitis, different levels of fibrosis, with transaminases significantly higher than normal and, as a rule, high viral load.
The vast majority of patients taking the medication leave positive feedback about the Sofosbuvir drug. Who was treated (reviews often contain such information) earlier from hepatitis C with interferons, suggests that the drugs can not even be compared. Interferons cause a lot of side effects, and not all patients have the strength to tolerate them. As for the combination of Sofosbuvir and Daclatasvir (most often patients talk about such a tandem), only a small percentage of those treated with these drugs spoke of the development of small negative effects in the form of dizziness, mild headaches and a short-term loss of coordination. However, these manifestations cannot be compared with the side effects of Interferon and the consequences of hepatitis. After 2-3 weeks of therapy, the transaminase content in the liver returns to normal in many patients. Starting from the third week of treatment with the complex of antiviral drugs Sofosbuvir and Daclatasvir, the result of the presence of hepatitis C virus in the body is negative for many patients.
Also, many patients report a significant reduction in fibrosis after several months of using complex therapy.
Those consumers who took a complex of three medicines - Sofosbuvir, Daclatasvir, Ribaverin - were also very pleased with the treatment results.
Almost all consumers of Sofosbuvir are talking about a real breakthrough in the treatment of viral hepatitis C compared with interferon therapy. The significantly improved health and quality of life of patients is direct evidence of this.