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Description:

 

Sofosbuvir online pharmacy

Sovaldi, the active ingredient in Sofosbuvir, acts as an analog nucleotide inhibitor of the NS5B polymerase, a critical enzyme of the hepatitis C virus, which controls viral replication. As a prodrug, Sofosbuvir is quickly transformed in the body into GS-331007 which is the substance comprising 9/10s or more of the pharmacologically active dose. GS-331007 is a compound which is well-absorbed by the body’s hepatocytes. These hepatocytes transform it, via cellular kinases, to the systemically-active 5’-tripohphate uridine analogue form known as GS-461203. This form closely resembles the naturally-occurring uridine nucleotide and so enters the Hep-C RNA polymerase. It is incorporated into the viral elongating RNA primer strand. This results in the termination of the chain, halting viral replication. GS-461203, as a pharmacologically active substance, has no effect on the body’s regular cellular DNA polymerases, mitochondrial RNA polymerases or RNA polymerases.

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United States of America Manufacturer

In the USA, Sofosbuvir is produced as Sovaldi by Gilead Sciences. Sofosbuvir was formally known as GS07977, which was initially formulated by Pharmasset and known at the time as compound PSI-7977. This drug was uncovered by researches as the more pharmacologically active component of PSI-7851, its parent compound.

US Federal Drug Agency Classification

5th of February 2016: FDA approval granted for sofosbuvir’s combined usage with daclatasvir, including or excluding ribavirin, for treatment of patients with chronic, genotype 1 Hep-C viral infections. The drug summary and prescribing info for daclatsavir gives further details.

24th of July 2015: FDA approval granted for the combined usage of Sofosbuvir with daclatasvir for treatment of patients with chronic, genotype 3 Hep-C viral infections.

5th of February 2015: the FDA modified a previous indication so as to allow the use of Sofosbuvir in combination with daclatasvir (including or excluding ribavirin) in the treatment of genotype 3 Hep-C sufferers. The drug summary and prescribing info for daclatasvir gives further details.

5th of November 2014: FDA approval granted for the combined usage of Sofosbuvir and daclatasvir for the treatment of chronic, gentotype 1 Hep-C viral infections. The drug summary and prescribing info for daclatasvir gives further details.

6t of December 2013: FDA approval granted for Sofosbuvir for treating suffers of chronic Hep-C infections, as well as for usage in combination therapies.

Sofosbuvir’s Indications

Sofosbuvir is intended only for treating sufferers of chronic Hepatitis C Virus.

It is to be used as follows:

  • Genotype 1 or 4 Hep-C: Sofosbuvir with ribavirin and peginterferon-alfa for 3 months.
  • Genotype 2 Hep-C: Sofosbuvir with ribavirin for 3 months.
  • Genotype 3 Hep-C: Sofosbuvir with ribavirin for 6 months.
  • HepC-HIV-1 co-infection: indications are as shown above.
  • Hep-C with hepatocellular carcinoma prior to liver translplant: Sofosbuvir with ribavirin for one year max or until transplant occurs.
  • Genotype 1 Hep-C where patient is ineligible for interferon: Sofosbuvir with ribavirin is an option for 6 months.

Sofosbuvir’s Contraindications

If Sofosbuvir is combined with ribavirin and peginterferon-alfa, all the relevant contraindications which apply to those two drugs will also apply to the combination therapy. Using Sofosbuvir and amiodarone is not advised as it increases the risk that symptomatic bradycardia may develop. This risk is further heightened in patients using beta-blockers and in patients with advanced diseases of the liver or existing cardiac conditions.

Dosage

Sofosbuvir comes in the form of a 400 mg. pill. Per recommendation, one of these pills should be taken daily by mouth, with a meal or not. This 400 mg. dose is suitable for patients with any kind of Hep-C genotype or medical history. The dose need not be adjusted for cases of moderate to mild impairment of renal or liver function . Sofosbuvir’s prescription guidelines do not offer a recommended dosage for patients with serious impairment of renal function (ie. an eGFR below 30 ml/min/1.73m2) or late stage renal disease which necessitates kidney dialysis. Additionally, Sofosbuvir is sold in combination with Ledipasvir 90 mg. as a fixed-dose tablet for combination therapy.

Clinical Application

Sofosbuvir exhibits pangenotypic Hep-C effects and is approved by the FDA for treating types 1 through 4. Sofosbuvir is recommended in patients both new and old to Hep-C drug therapies. It is suitable for those with such additional conditions as AIDS, liver cancer and cirrhosis. Sofusbuvir research has been conducted across broad demographics, including the elderly and those with slight to significant impairment of the renal system. Sofosbuvir may be used in concert with certain other drugs, such as daclatasvir and simprevir, with which it is complimentary.

 

Sofosbuvir and Expectant Mothers

The FDA has classified Sofosbuvir as Pregnancy Category B. Studies conducted with animals, specifically rabbits and rats, have demonstrated no adverse effects on fetal development. However, no such studies have been conducted with human females.

When combined with peginterferon or ribavirin, Sofosbuvir treatment falls into the FDA’s Pregnancy Category X. This is because Ribavirin is known to contribute to the development of birth defects in fetuses and may even kill the fetus. It should be avoided by both the woman and male partner, as it can be transmitted sexually.

Women who might be carrying a child should definitely confirm their pregnancy status before beginning with Sofosbuvir and peg interferon or ribavirin combination therapy. Avoid conception for at least half a year following any such treatment to avoid any potential problems with fetal development. Also ensure you are not carrying a child during and before beginning any such treatment. Use contraception for the duration of treatment and six months thereafter so as to avoid any accidental conception.

If you test positive for pregnancy, inform your doctor at once. Your doctor should then contact the Ribavirin Pregnancy Registry on your behalf and put you in contract with this public health agency, whose function is to record all relevant information relating to pregnant women who are exposed to ribavirin, either through medical treatment or through a partner.

Side Effects

Sofosbuvir usually only causes mild side effects and those only rarely. It is more common to experience adverse effects when Sofosbuvir is combined with ribavirin, in which case tiredness or headaches may result. Sofosbuvir, used by itself, is a Pregnancy Category B drug. For further information or to report side effects, the FDA may be contacted at 1-800-FDA-1088 or the manufacturer, Gilead Sciences, may be reached at 1-800-GILEAD-5.

Interactions with Other Drugs

Sofosbuvir is not recommended to be used alongside any medications with promote P-glycoprotein in the intestines, for example St. John’s Wort and rifampin. These drugs cause a marked reduction in the availability of GS-331007 and Sofosbuvir. They will render the Sofosbuvir treatment ineffective or unreliable.

It is further recommended that patients avoid all of the following drug classes when taking Sofosbuvir, as they all have potentially unwanted interactions:

  • HIV Protease Inhibitors, such as tipranavir-ritonavir.
  • Alternative herbal remedies, particularly Hypericum Perforatum (St. John’s Wort).
  • Anti-mycobacterial drugs, such as rifapentine, rifampin and rifabutin.
  • Anti-convulsants,, including phenytoin, phenobarbital, oxycarbazepine and carbamazepine

Resistance to Sofosbuvir

There is a considerable genetic barrier to Sofosbuvir resistance. Research up to this time has shown a total of 3 changes to the amino acids of patients receiving Sofosbuvir. There changes occur with the following amino acids: V321A, S282T and L159F. Here is how they are affected:

  • L159F and V321A mutations have been proven to occur in patients with Hep-C genotype 3a after using Sofosbuvir. Such changes did not affect phenotypic resistance.
  • Mutations in L159F were seen in those with genotype 2b or 1a Hep-C and hepatocellular carcinoma when on extended Sofosbuvir treatments of up to 12 months. Such patients were awaiting transplantation of their livers. They were shown to have C316N and L159F mutations consistent with viral breakthrough relapse following the transplant.
  • S282T mutations were detected following Sofosbuvir in a patient with Hep-C of genotype 2b. This patients was on a course of Sofosbuvir alone. The S282T isolate which mutated was found to have a mean 13.5-fold diminished response to Sofosbuvir.

Complete Prescribing Information

Detailed information on Sovaldi (Sofosbuvir) prescription.

Summary

Sofosbuvir has been shown to be a revolutionary drug for those suffering from Hep-C infections. It combines a number of desirable and convenient properties:

  • a single daily dose which is unaffected by food,
  • minor adverse effects, low potential for unwanted drug interactions,
  • pangenotypic activity,
  • considerable genetic barriers in terms of resistance,
  • high levels of safety and effectiveness, even in patients presenting severe disease of the liver,
  • impressive, long-lasting virologic rate of response even in patients with unsuitable baseline characteristics.

The new AASLD-IDSA guidelines for treating Hep-C recommend the combined application of peg interferon and Sofosbuvir for those patients presenting with genotype 6,5,4 and 1 infections. Additionally, those patients unsuited for interferon treatment, should be prescribed simeprevir (including or excluding ribavirin) alongside Sofosbuvir, although the FDA has not yet officially approved this approach. Those patients with type 2 or 3 Hep-C are advised to use ribavirin with Sofosbuvir. Sofosbuvir, when used as a component in combination therapy alongside ribavirin, represents the earliest oral therapy for Hep-C approved by the FDA. It is notable that its effectiveness is greater for genotype 3 strains than genotype 2, although type 3 requires a lengthier course of treatment than type 2. Sofosbuvir is also very helpful in treating chronic Hep-C infections although the expensive nature of this drug militates against its use as a common general treatment.

Sofosbuvir and Hepcivir Price in the USA

The USA listed costs for 4 months of combination therapy using a Sofosbuvir compound will cost between $84k and $94k. The following House Democrats: Diane DeGette, Frank Pallone Jr. and Henry Waxman, collaborated on a missive to Gilead Sciences in which the high cost was questioned. These politicians requested that the CEO of Gilead, John Martin, explain the drug’s pricing and demanded discounts on the drug for poor patients and public health programs. They also asked about the possible downstream effects on public health should insurance companies delay or restrict access to the drug due to its expense. Sofosbuvir is an oft-cited example of both the positive and negative aspects of specialty pharmaceuticals.

Gilead made public, in February 2015, that they had successfully negotiated patient discounts with various dispensary benefit managers. Legally-enforced discounts were made available to state payers, resulting in an average cost reduction of the 2014 list price by 22 percent. Gilead made the estimate that the 2015 discount would be on the order of 46 percent. A forum of pharmaco-economic experts, patient rights advocates and managed care industry reps, known as the California Technology Assessment Forum, stated that the 46 percent cost reduction would reduce the typical cost of Sofosbuvir treatment to roughly $40k. It was the opinion of this board that, at such a price point, Sofosbuvir treatment represents good value to healthcare programs and patients alike.

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Sofosbuvir’s Price in Germany and France

Gilead and Germany health insurance companies worked out a deal which resulted in a cost of €41k for 4 months’ worth of Sofosbuvir medication. This is the same as the drug’s cost within France, although the French public health system offers further rebates and/or discounts, dependent on sales volume and incidence of failed treatments. We recommend to buy Hepcivir at our online pharmacy.

Sofosbuvir’s Price in the UK

The cost of Sofosbuvir in Britain is likely to be in the range of £35k (which is about $68k) for a 4 month course. The National Health Service has created 22 so-called Operational Delivery Networks which serve to expedite delivery. These services were launched in 2015 by the National Institute for Health and Care Excellence, which aims to sponsor 10k treatment courses over the years 2016 to 2017. There is a pre-determined “run rate” which governs the number of patients which may receive this treatment. Sofosbuvir funding represents the greatest investment into a new treatment by the NHS for the year 2015.

Sofosbuvir’s Price in Asia

Distinct from Western nations, the cost of Sofosbuvir in considerably cheaper in countries like South Korea and Japan, where the cost of a 4 month course is a comparatively-low $5900 on the high end, down to as little as $300. The governments in these countries offset the drug’s cost by 70 and 99 percent accordingly.

Gilead declared in September 2015 that they would pursue licensing agreements with generic manufacturers such that generic Sofosbuvir may be produced in over 90 third world nations; such nations housing 54 percent of the world’s Hepatitis C patients. Gilead also stated they would begin distribution of their branded product within the nation of India for a cost of only $300 per 4 month course. This amount was two times that of an independent estimate of the lowest achievable cost of production. The head of an Indian patient activist group described the pricing as “inadequate.”

Doctors without Borders member, Jennifer Cohn, alongside the group, Doctors of the World, also complained of the expense of Sofosbuvir, characterizing it as “corporate greed,” despite the dramatically reduced cost of the drug in the third world. By way of contrast, the index Access to Medicines placed Gilead first among twenty of the largest international pharmaceutical firms in terms of Pricing, Distribution and Manufacturing for the years 2014 and 2013. They described Gilead as leading in terms of equitable pricing, despite the very high cost of the drug in the First World.

Sofosbuvir’s Price in Algeria

In 2011, Algeria’s reported Hep-C infection rate was roughly 70,000 infected.

By August of 2015, Gilead had granted license to an Indian partner to distribute Sofosbuvir within Algeria. The company was criticized for its delay in making the drug available in such less-prosperous nations before that time.