Sovriad - instructions for use, reviews, analogs and formulations (capsules or tablets 150 mg) of the drug for the treatment of chronic viral hepatitis C in adults, children and pregnancy. Composition

In this article, you can read the instructions for using the drug Sovriad. Comments of visitors of the site - consumers of this medication, as well as opinions of doctors of specialists on the use of Sorrow in their practice are presented. 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 Sovriada in the presence of existing structural analogs. Use for the treatment of chronic viral hepatitis C in adults, children, as well as in pregnancy and lactation.Composition of the preparation.

Sovriad - Symeprevir (the main active substance of the drug Sovriad) is an inhibitor of the protease of the hepatitis C virus, which plays a key role in the replication of the virus. According to the results of biochemical blood analysis simeprevir inhibited the proteolytic activity of recombinant hepatitis C virus protease genotypes 1a and 1b with the median values ​​of Ki 0,5 and 1.4 nmol per liter, respectively.

Composition

Simeprivir sodium + auxiliary substances.

Pharmacokinetics

Pharmacokinetic properties simeprevira evaluated in healthy adult volunteers and adult patients infected with hepatitis C. The values ​​of maximum plasma concentration after repeated use of the drug in doses of from 75 mg to 200 mg 1 time per day increased more than proportionally to dose; After repeated administration of the drug, its accumulation was observed. The steady-state concentration of the substance in the blood was reached after 7 days of application once a day. Simeprevira concentration in the plasma of infected hepatitis C virus patients is 2-3 times higher than the corresponding values ​​in healthy volunteers.The values ​​of the maximum concentration of simeprevir in plasma when combined with peginterferon alfa and Ribavirin and with monotherapy with simeprevir were similar.

Symeprivir has good bioavailability when taken orally. The maximum concentration is usually achieved in 4-6 hours after taking the drug. Symeprevir binds to a large extent with plasma proteins (more than 99.9%), mainly with albumin and to a lesser extent with alpha-1-acid glycoprotein. In patients with impaired renal or hepatic function, no significant changes in binding to plasma proteins have been recorded.

Symeperivir is metabolized in the liver. According to the results of in vitro studies on microsomes of human liver, the simeprevir is predominantly exposed to oxidative metabolism by means of the CYP3A isoenzyme of the liver. It is also impossible to exclude the participation of CYP2C8 and 2C19 isoenzymes.

Indications

Treatment of chronic hepatitis C of genotype 1 in combination with peginterferon alfa and ribavirin in adult patients with compensated liver disease (including cirrhosis) who have not previously received treatment or who have previous treatment (based on Interferon pegylated orunpaired with or without ribavirin) was ineffective. The drug Sovriad can not be used as a monotherapy.

Forms of release

Capsules 150 mg (sometimes mistakenly called pills).

Instructions for use and dosing regimen

The recommended dose of Sovriad is 1 capsule (150 mg) orally once a day with meals. The type of food does not affect the pharmacokinetic parameters of the simeprevir. Capsules should be swallowed whole. Sovrirad should be used in combination with peginterferon alfa and ribavirin.

The recommended duration of treatment with the drug Sovriad in combination with peginterferon alfa and ribavirin is 12 weeks.

In previously untreated patients and patients with a history of relapse, including patients with cirrhosis, after completing a 12-week treatment with the medication Sodriad in combination with peginterferon alfa and ribavirin, therapy with peginterferon alfa and ribavirin should be continued for another 12 weeks ( the total duration of therapy is 24 weeks).

In patients with ineffectiveness of previous therapy (including lack of response or partial response), including patients with cirrhosis of the liver,after the completion of a 12-week therapy with the drug Sovriad in combination with peginterferon alfa and ribavirin, the therapy with peginterferon alfa and ribavirin should be continued for another 36 weeks (the total duration of therapy is 48 weeks).

Side effect

• constipation;
• increased levels of bilirubin in the blood;
• rash;
• itching;
• photosensitivity reaction;
• dyspnea.

Contraindications

• increased sensitivity to simeprevir or any auxiliary component of the drug;
• children and adolescents under 18;
• pregnancy, including the pregnancy of a female partner of a man undergoing treatment with the drug Sovriad in combination with peginterferon alfa and ribavirin;
• lactation period;
• deficiency of lactase;
• lactose intolerance;
• glucose-galactose malabsorption;
• impaired renal function (KK less than 50 ml per minute);
• decompensated cirrhosis of the liver;
• impaired liver function of medium and severe degree (classes B and C on the Child-Pugh scale);
• simultaneous administration with drugs that are moderate or potent inducers or inhibitors of the CYP3A isoenzyme: anticonvulsants (carbamazepine, oxcarbazepine, phenobarbital, phenytoin),blockers of H1-histamine receptors (astemizole, terfenadine), antibiotics (erythromycin, clarithromycin, telithromycin), antifungal drugs for oral administration (itraconazole, ketoconazole, posaconazole, fluconazole, voriconazole), antituberculosis drugs (rifampicin / rifampin, rifabutin, rifapentin), glucocorticoid drugs (dexamethasone for systemic use), prokinetics (cisapride), herbal preparations (milk thistle (Silybum marianum), St. John's wort (Hypericum perforatum), preparations for the treatment of HIV infection (preparations containing non-nucleoside reverse transcriptase inhibitors: efavirenz, delavirdine, etravirine, nevirapine, protease inhibitors: a combination of darunavir / ritonavir, ritonavir, atazanavir, fosamprenavir, amprenavir, lopinavir, indinavir, nelfinavir, saquinavir, tipranavir).

Carefully:

• in patients with impaired renal function of a serious degree (QC less than 30 ml per minute);
• in elderly patients (over 65 years);
• with simultaneous application with drugs metabolized predominantly by the isoenzyme CYP3A4, as well as with drugs that are substrates of P-glycoprotein (antiarrhythmic drugs - amiodarone, disopyramide, flecainide, lidocaine (systemic), mexiletine, propafenone,quinidine; blockers of slow calcium channels - amlodipine, bepridil, diltiazem, felodipine, nicardipine, nifedipine, nisoldipine, verapamil; sedatives and anxiolytics - midazolam, triazolam).

Application in pregnancy and lactation

The use of the drug Sovriad in combination with peginterferon alfa and ribavirin is contraindicated in pregnancy, including during pregnancy of a female partner of a male receiving treatment, due to the fact that when using ribavirin, significant teratogenic effects leading to embryo death were observed. Care must be taken to prevent pregnancy in women undergoing treatment, as well as in female partners of men undergoing therapy. Reproductive patients and patients with fertile partners should start taking ribavirin only if they use a combination of two effective contraceptives throughout the treatment, and also within 6 months after the end.

It is not known whether simeprevir and its metabolites are excreted in human breast milk.Because of the possible adverse effect of the drug Sovrirad on infants, it is necessary to decide whether to stop breastfeeding or to refuse treatment with the drug Sorrow, taking into account the benefits of breastfeeding for the baby and the positive effects of therapy in the mother.

Use in children

The safety and efficacy of the drug Sorrow in children and adolescents under the age of 18 years has not been studied. The use of the drug in this category of patients is contraindicated.

Application in elderly patients

Data on the safety and efficacy of the drug Sorrow in elderly patients (over 65 years) are limited. Dose adjustments in elderly patients are not required.

special instructions

It is not allowed to use the medication Sovriad as a monotherapy. Symeprevir should be administered in combination with peginterferon alfa and ribavirin. Therefore, before starting therapy, you should read the instructions for the use of peginterferon alfa and ribavirin. The safety and efficacy of simeprevir in combination with drugs for the treatment of hepatitis C, in addition to peginterferon alfa and ribavirin,not studied.

RNA levels of hepatitis C virus should be assessed at 4 and 12 weeks according to clinical indications. To monitor the level of hepatitis C virus RNA during therapy, it is recommended to use a sensitive quantitative analysis of hepatitis C virus RNA. The requirements for the initial, and also the results of a general clinical blood test, a biochemical blood test (including liver enzyme and bilirubin assays) and to pregnancy tests are given in the instructions for the use of peginterferon alfa and ribavirin.

Photosensitivity reactions (predominantly of mild or moderate degree) were observed in patients receiving treatment with Sovriad in combination with peginterferon alfa and ribavirin. It is necessary to use appropriate sun protection during the therapy with the drug Sovrirad in combination with peginterferon alfa and ribavirin. The use of tanning enhancers, as well as prolonged exposure to direct sunlight, is contraindicated during therapy with the drug Sovrirad in combination with peginterferon alfa and ribavirin.

The rash was observed in patients undergoing treatment with the medication Sovriad in combination with peginterferon alfa and ribavirin. The rash most often appeared in the first 4 weeks of therapy, but its appearance is possible at any time during treatment. There was also a severe rash and a rash, requiring the withdrawal of therapy with the drug Sovriad. Most often a rash of mild or moderate degree was noted. Patients with mild to moderate rash should be under the supervision of the doctor for possible progression of the rash, including the development of mucosal lesions (eg, mucosal lesions, conjunctivitis) or systemic manifestations. In the event that the rash passes into severe form, therapy with the drug Sovriad should be canceled. Patients should be carefully monitored until the appearance of the rash disappears.

Drug Interactions

The main isoenzyme involved in the metabolism of simeprevir is CYP3A. Thus, it is possible to develop clinically relevant effects of other drugs mediated by the CYP3A isoenzyme on the pharmacokinetics of the simeprevir.Symeprivir does not induce inducing action on CYP1A2 or 3A4 isoenzymes in human hepatocytes.

The simultaneous use of simeprevir with potent inhibitors of the CYP3A isoenzyme may lead to a significant increase in the concentration of the simeprevir in the plasma, while co-administration with powerful inducers of the CYP3A isoenzyme can significantly reduce the concentration of the simeprevir in the plasma and lead to a loss of its effectiveness. Thus, it is not recommended to use the medication Sovriad together with substances that are potent inhibitors or inducers of the activity of the CYP3A isoenzyme.

The combined use of the drug SOVRIA with preparations that are substrates of transport proteins OATP1B1 and P-glycoprotein can lead to an increase in the concentration of such drugs in plasma.

Analogues of medicinal medicine Sovriad

Sovriad does not have structural analogs for the active substance.

Analogues for the pharmacological group (antiviral, except for HIV, funds):

• Avonex;
• Aktaviron;
• Actipol;
• Aldara;
• Alloferon;
• Alpisarin;
• Algeron;
• Algiers;
• Altevir;
• Alfaron;
• Alfaferon;
• Amizon;
• Amiksin;
• Arbidol;
• Arviron;
• Afludol;
• Acigerpine;
• Acyclovir;
• Acyclostad;
• Aeros;
• Baraklid;
• Bencarmet;
• Valaciclovir;
• Valwyr;
• Valmic;
• Valtrex;
• Valtsikon;
• Valcite;
• Virazole;
• Viferon;
• Ganciclovir;
• Gervirax;
• Gerpevir;
• Gerperax;
• Herpes;
• Daklataswir;
• Zovirax;
• Imiquimod;
• Imichimod;
• Influucine;
• Kagocel;
• Lavomax;
• Ladivin;
• Lacrinate;
• Lamuzide;
• Lysavir;
• Moliksan;
• Nevirapine;
• Nomides;
• Normomed;
• Oxolin;
• Orvire;
• Panavir;
• Provirsan;
• Realdiron;
• Rebetol;
• Rebif;
• Remantadine;
• Ribavin;
• Ribamidyl;
• Ribapeg;
• Riluzole;
• Rimantadine;
• Ronbetal;
• Roferon;
• Sovriad;
• Sofosbuvir;
• Tamiflu;
• Thilaxin;
• Tiloram;
• Tyloron;
• Trivorin;
• Famacivir;
• Famvir;
• Familar;
• Famciclovir;
• Fenistil;
• Ferrovir;
• Helepin;
• Tsivilgan;
• Cyclovir;
• Tsemeven;
• Extavia;
• Entecavir.

Response of infectious diseases physician

Sovriad is an effective antiviral drug developed specifically for the treatment of chronic forms of viral hepatitis C. The drug is used exclusively for complex therapy in combination with ribavirin and peginterferon alfa. I assign Sovrirad to adult patients suffering from compensated liver disease (cirrhosis inclusive) with chronic hepatitis and previously untreated.The medication is also suitable for patients in whom previous therapy with interferon (pegylated or unpigilated) did not bring the desired results. Capsules are taken once a day, one by one. The course of treatment is long and can, depending on the patient's condition, be from 12 to 48 weeks.

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