Sofosbuvir - instructions for use, reviews, analogs and dosage forms (tablets 400 mg Sovaldi) drugs for the treatment of hepatitis C genotype 1, 2, 3 and 4 in adults, children and pregnancy. Composition, price and prospects of entering the Russian market
In this article, you can read the instructions for using the drug Sofosbuvir. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors specialists on the use of Sofosbuvira (Sovvaldi) in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Sofosbuvir in the presence of existing structural analogues.Use for the treatment of hepatitis C genotype 1, 2, 3 and 4 in adults, children, as well as during pregnancy and lactation. Composition, cost and prospects of the drug on the Russian market.
Sofosbuvir - the nucleotide analogue is used in combination with other drugs for the treatment of hepatitis C. On the world market from 2013. Compared with other medicines, sophosbuvir showed higher efficacy, fewer side effects and a 2-4 times shorter duration of therapy. Sofosbuvir allows you to stop using Interferon alfa-antiviral drug with a series of side effects, the main element in the treatment of hepatitis C in many countries, including Russia.
Sofosbuvir inhibits RNA polymerases used by the hepatitis C virus to copy its own RNA. Sofosbuvir is produced by the company Gilead.
>> How to buy Sofosbuvir in Russia <<
In 2013, the Food and Drug Administration in the United States approved the use of somosbuvira in combination with Ribavirin as non-injectable hepatitis C therapy for the 2nd and 3rd genotype, and for combined triple therapy (cofosbuvir + ribavirin (oral) ) + interferon alfa (injections)) for the treatment of hepatitis C of the 1st and 4th genotypes.In 2014, a successful combination of sophosbuvira with lepidavir opened the possibility of treating hepatitis C of the first genotype without the use of interferon alfa. Clinical data on the use of sophosbuvira in patients with genotype 5 or 6 are limited.
Composition
Sofosbuvir + auxiliary substances.
Indications
- chronic hepatitis C of genotype 1, 2, 3 and 4 (in combination therapy).
Forms of release
Tablets 400 mg (under the trademark Sovaldi (Sovaldi)).
Instructions for use and treatment regimen
Therapy should be conducted only by physicians with experience in the management of chronic hepatitis C. It is recommended that the drug be used in combination with other medicines. Софосбувими monotherapy is not recommended.
The recommended dose for adult patients is one 400 mg tablet per day during one meal.
Combination Therapy
- With hepatitis C of genotype 4, 5 or 6, a combination of Sovaldi (somosbuvir) + ribavirin + Interferon alfa is used for more than 12 weeks.
- In hepatitis C genotype 1, 4, 5 or 6 - with ribavirin (only in patients with contraindications to the use of interferon alfa or having intolerance to interferon) for more than 24 weeks.
- With hepatitis C of genotype 2 - with ribavirin for more than 12 weeks.
- With hepatitis C of genotype 3 - with ribavirin and interferon alpha more than 12 weeks.
- Patients with hepatitis C who are waiting for a liver transplant receive a combination of cofosbuvir + ribavirin before transplantation. The scheme is valid for patients with co-infection with hepatitis and HIV.
The duration of therapy can be increased to 24 weeks, especially in patients with one or more negative factors, such as progressive fibrosis / cirrhosis, high initial viral load, black skin, previously no response to ribavirin and interferon alfa.
The dose of ribavirin for combination therapy depends on the weight of the patient (75 kg = 1,200 mg), divided into two parts and is also taken with meals.
It is not recommended to reduce the dose of sophosbuvira.
If the combined use of cofosbuvira with interferon alpha, serious side effects associated with this drug occur, you should reduce the dose of interferon or completely cancel the drug. The rules for reducing the dose or stopping the use of interferon are prescribed in special instructions.
If serious side effects associated with ribavirin occur, the dose of ribavirin should be reduced accordingly or the drug should be completely withdrawn.The rules for reducing the dose or stopping ribavirin intake are prescribed in special instructions.
After abolishing ribavirin based on improved blood tests and clinical symptoms, you can try to resume taking the drug at a dosage of 600 mg daily, increasing it to 800 mg. However, further administration of the drug at the initial dose (1,000 mg and 1,200 mg daily) is not recommended.
Method and duration of admission
- Because of the bitter taste, the tablet should be swallowed without chewing or dividing into parts. Take with food.
- If there is vomiting within 2 hours after taking the medication, you should take an extra pill. In the case of vomiting after 2 hours, no additional pill is needed.
- If the medication is missed, if you are less than 18 hours late, you must take the missed pill. The next tablet is taken at the usual time. At a delay of more than 18 hours, take the next tablet at the usual time.
Discontinuation of treatment
With the complete cancellation of one of the drugs with a combined admission, you should cancel and receive sophosbuvira.
EASL 2017 Guidelines for HCV Therapy
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Side effect
- insomnia;
- headache;
- migraine;
- decreased appetite;
- convulsions;
- dizziness;
- nausea, vomiting;
- diarrhea, constipation;
- dry mouth;
- fatigue;
- depression;
- irritability;
- anemia, neutropenia, a decrease in the number of lymphocytes and platelets;
- skin rashes;
- itching;
- rash;
- pain in the joints;
- myalgia;
- chills;
- fever;
- cough;
- rhinopharyngitis;
- impaired vision;
- hair loss;
- dry skin;
- chest pain;
- asthenia.
Contraindications
- hypersensitivity to the drug and its components.
Caution should be used in women of reproductive age.
Application in pregnancy and lactation
Caution should be used in women of reproductive age. When applying Sovaldi (Sofosbuvira) in combination with ribavirin and interferon alpha, the onset of pregnancy is undesirable. Avoid the use of medication during pregnancy and lactation. There are no data on the effect of the drug on reproductive performance.
Use in children
Data on the safety and efficacy of taking Sofosbuvira in children and adolescents under the age of 18 are not available.
special instructions
The price of Sofosbuvir in the United States varies from $ 84,000 to $ 168,000 per course for different rates, in the UK, 35,000 pounds for a 12-week course.In September 2014, Gilead announced that it will issue production licenses for 91 developing countries. The estimated cost of sophosbuvira in India or China is estimated at $ 300 per course.
At the end of 2015, Sofosbuvir is in the process of preparing for registration in Russia. It is worth to expect the appearance of this drug in our market in the foreseeable future. Perhaps (due to the spread of generics), at that time the medicine will have an adequate cost of treatment available to our patients, including free-of-charge programs.
The drug is included by WHO in the list of essential medicines.
Drug Interactions
The use with other antiviral drugs can be allowed only if, according to available data, the benefit exceeds possible risks. It is not recommended to take cofosbuvira and telaprevir or boceprevir together. It is not recommended to take together with drugs that are strong inducers of glycoproteins in the intestine (rifamycin, zveroboi, carbamacepin and phenytoin).
Analogues of the drug Sofosbuvir
Structural analogs for the active substance:
- Viropak (MPI Viropack) (Egypt);
- Grateziano (Egypt);
- Hepcinat (India);
- Hopetavir (Bangladesh).
Analogues on the curative effect (drugs for the treatment of chronic hepatitis C):
- Algeron;
- Altevir;
- Alfaron;
- Asunaprevir;
- Daklataswir;
- Ingaron;
- Intron A;
- Layfferon;
- Ladipasvir;
- Moliksan;
- Neovir;
- Pegasys;
- Peginterferon;
- PegIntron;
- Realdiron;
- EU Reaferon;
- Rebetol;
- Ribavirin Meduna;
- Ribamidyl;
- Roferon A;
- Sovriad;
- Ferrovir;
- Cycloferon.
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