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SOVALDI Rx (Sofosbuvir 400mg; tabs.) NEW Medicine! 
Listing ID: 237
€1 EUR
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SOVALDI Rx (Sofosbuvir 400mg; tabs.)


2/9/2014
Gilead Sciences, Inc.
Sofosbuvir 400mg; tabs.

As a component of a combination antiviral treatment regimen for chronic hepatitis C (CHC) genotype 1, 2, 3, or 4 infection, including those with hepatocellular carcinoma meeting Milan criteria (awaiting liver transplant), and those with HCV/HIV-1 co-infection.

Drug Product Name: SOVALDI Rx
Pharmacological Class:
Hepatitis C virus (HCV) NS5B polymerase inhibitor

Active Ingredient(s):
Sofosbuvir 400mg; tabs.
Company
Gilead Sciences, Inc.

Indication(s):

As a component of a combination antiviral treatment regimen for chronic hepatitis C (CHC) genotype 1, 2, 3, or 4 infection, including those with hepatocellular carcinoma meeting Milan criteria (awaiting liver transplant), and those with HCV/HIV-1 co-infection. Not for use as monotherapy.

Pharmacology:
Sofosbuvir is an inhibitor of the HCV NS5B RNA-dependent RNA polymerase, which is essential for viral replication. This nucleotide prodrug undergoes intracellular metabolism to form the pharmacologically active uridine analog triphosphate (GS-461203), which can be incorporated into HCV RNA by the NS5B polymerase and acts as a chain terminator.

Clinical Trials:

The safety and efficacy of Sovaldi was evaluated in five Phase 3 trials in a total of 1,724 HCV mono-infected subjects with genotypes 1–6 CHC and one Phase 3 trial in 223 HCV/HIV-1 co-infected subjects with genotype 1, 2 or 3 CHC. The primary endpoint was sustained virologic response (SVR) which was defined as HCV RNA less than lower limit of quantification at 12 wks after the end of treatment.
NEUTRINO was an open-label, single-arm trial that evaluated 12 wks of treatment with Sovaldi in combination with peginterferon (PegIFN) alfa 2a and ribavirin (RBV) in treatment-naïve subjects (N=327) with genotype 1, 4, 5 or 6 HCV infection compared to pre-specified historical control SVR rate of 60% (P<0.001). The overall SVR rate was 90% (295/327). The SVR rates by specific genotype were: Genotype 1 (89%) and Genotype 4 (96%).
FISSION was an active-controlled trial that evaluated 12 wks of treatment with Sovaldi + RBV vs. 24 wks with PegIFN + RBV in treatment-naïve subjects with genotype 2 and 3 HCV. The overall SVR rate for both arms were 67%. The SVR rates for Genotype 2 was (95% vs. 78%) and Genotype 3 was (56% vs. 63%) in the Sovaldi  + RBV arm compared to the PegIFN + RBV arm, respectively.
For more clinical trial data, see full labeling.

Legal Classification:
Rx

Adults:

400mg once daily. Genotype 1: treat for 12 wks (with ­PegIFN alfa + RBV) or 24 wks (with RBV) if interferon-based regimen ineligible. Genotype 2: treat for 12 wks (with RBV). Genotype 3: treat for 24 wks (with RBV). Genotype 4: treat for 12 wks (with PegIFN alfa + RBV). Hepatocellular carcinoma: treat up to 48 wks (with RBV) or until time of liver transplant, whichever occurs first. Dose reduction of sofosbuvir is not recommended. Other dose modifications: see full labeling. If peginterferon alfa or ribavirin are discontinued, sofosbuvir should also be discontinued.

Children:
<18yrs: not established.

Contraindication(s):
Pregnant ­wom­en and in men whose partners are pregnant (note: ribavirin is Cat. X). Peginterferon and ribavirin contraindications also apply to combination therapy with sofosbuvir.

Warnings/Precautions:

Female patients/partners of male patients must have (–) pregnancy test before initiating therapy; use 2 effective non-hormonal methods of contraception during and for 6 months after treatment completion; perform routine monthly pregnancy test. Severe renal impairment or ESRD. Decompensated cirrhosis. Post-liver transplant recipients. Pregnancy (Cat. B). Nursing mothers: not recommended.

Interaction(s)

Avoid concomitant strong P-gp inducers (eg, rifampin, St. John’s wort). Antagonized by carbamazepine, phenytoin, phenobarbital, oxcarbazepine, rifabutin, rifapentine, tipranavir/ritonavir; avoid concomitant use. May be co-administered with P-gp and/or BCRP inhibitors (see full labeling).

Adverse Reaction(s)

Fatigue, headache, nausea, insomnia, anemia, pruritus, rash.

Notes:
For peginterferon alfa and ribavirin specific dosing and safety information, refer to their respective prescribing information.
How Supplied:
Tabs—28
Price: €1 EUR
Listing ID: 237
Apoteket

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