HEPATITIS C

Sofosbuvir With Velpatasvir is a two-drug combination for the treatment of hepatitis C. It is administered as a single daily pill containing the viral NS5A inhibitor velpatasvir and sofosbuvir, a nucleotide inhibitor of the viral RNA polymerase. It is the first treatment, that works for all genotypic, and is taken entirely by mouth. A single tablet regimen is used for adults with genotype 1-6 chronic hepatitis C virus (HCV) infection.

Sofosbuvir With Velpatasvir is an oral fixed-dose combination of sofosbuvir, a nucleotide analog NS5B polymerase inhibitor and velapatasvir, an NS5A replication complex inhibitor. Sofosbuvir is approved for the treatment of genotype 1, 2, 3 and 4 HCV infection with different regimens and durations dependent on the HCV genotype. Velpatasvir (formerly GS-5816) is a novel NS5A inhibitor that has potent invitro anti-HCV activity across all genotypes at the picomolar level. The combination of sofosbuvir-velpatasvir is the first once-daily single-tablet regimen with pangenotypic activity.

Sofosbuvir With Velpatasvir is available as a coformulated, once-daily single-pill combination of sofosbuvir 400 mg and velpatasvir 100 mg. The recommended dose is one tablet once daily, taken with or without food.

• Renal Impairment: For patients with mild to moderate renal impairment, no dosage adjustment of sofosbuvir-velpatasvir is recommended. There are insufficient data regarding the safety and efficacy of sofosbuvir-velpatasvir in patients with severe renal impairment (eGFR less than 30 ml/min/1.73m2) or end-stage renal disease requiring hemodialysis. Accordingly, no dosage recommendation has been given for patients with severe renal impairment or end-stage renal disease requiring dialysis.
• Hepatic Impairment: For patients with mild, moderate, or severe hepatic impairment (Child-Pugh Class A, B, or C), no dosage adjustment for sofosbuvir-velpatasvir is recommended. For patients with decompensated cirrhosis who are receiving sofosbuvir-velpatasvir and ribavirin, clinical and laboratory monitoring is recommended.

Risk of Serious Symptomatic Bradycardia When Sofosbuvir Is Coadministered with Amiodarone and Another HCV Direct Acting Antiviral: Amiodarone is not recommended for use with Sofosbuvir With Velpatasvir due to the risk of symptomatic bradycardia, particularly in patients also taking beta blockers or with underlying cardiac comorbidities and/or with advanced liver disease. In patients without alternative, viable treatment options, cardiac monitoring is recommended. Patients should seek immediate medical evaluation if they develop signs or symptoms of bradycardia.

Risk of Reduced Therapeutic Effect Due to Concomitant Use of Sofosbuvir With Velpatasvir with P-gp Inducers and/or Moderate to Potent Inducers of CYP2B6, CYP2C8 or CYP3A4: Rifampin, St. John's wort, and carbamazepine are not recommended for use with Sofosbuvir With Velpatasvir as they may significantly decrease sofosbuvir and/or velpatasvir plasma concentrations.

Dolutegravir is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in adults and children 12 years of age and older and weighing at least 88 pounds (40 kilograms). Dolutegravir is always used in combination with other HIV medicines.

Dolutegravir belongs to a class (group) of HIV drugs called integrase inhibitors. Integrase inhibitors block an HIV enzyme called integrase. (An enzyme is a protein that starts or increases the speed of a chemical reaction.) By blocking integrase, integrase inhibitors prevent HIV from multiplying and can reduce the amount of HIV in the body. HIV medicines can’t cure HIV/AIDS, but taking a combination of HIV medicines (called an HIV regimen) every day helps people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV transmission

What side effects can dolutegravir cause?

Dolutegravir may cause side effects. Most side effects from dolutegravir are manageable, but a few can be serious. Serious side effects of dolutegravir include allergic reactions and liver problems. (See the WARNING above.)Other possible side effects of dolutegravir include:

Changes in liver test results. People with a history of HBV or HCV may have an increased risk of developing new or worsening changes in certain liver test results during treatment with dolutegravir.
Changes in body fat (including gain or loss of fat).

Immune reconstitution inflammatory syndrome (IRIS), a condition that sometimes occurs when the immune system begins to recover after treatment with an HIV medicine. As the immune system gets stronger, it may have an increased response to a previously hidden infection.
Trouble sleeping.
Tiredness.
Headache.
Tell your health care provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of dolutegravir. To learn more about possible side effects of dolutegravir, read the drug label or package insert or talk to your health care provider or pharmacist.The AIDSinfo fact sheet on HIV Medicines and Side Effects also includes information that may apply to dolutegravir.

30 Tab

Brand Name LEDIKAST
Contents Ledipasvir and Sofosbuvir
Marketed by Aprazer Health Care
Manufactured by Natco Pharma Limited
Strength - Each film-coated tablet Contains 90 mg Ledipasvir and 400 mg Sofosbuvir
Form Tablets
Packing Pack of 28 Tablet

Each film-coated tablet contains 90 mg ledipasvir and 400 mg sofosbuvir. The tablet includes the following inactive ingredients colloidal silicon dioxide, copovidone, croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The tablet is film-coated with a coating material containing the following inactive ingredients Yellow Oxide of Iron, polyethylene glycol, polyvinyl alcohol, talc, FD&C Blue #2 and titanium dioxide IP. -

Ledipasvir The IUPAC name for ledipasvir is Methyl [(2S)-1-{(6S)-6-[5-(9,9-difluoro-7-{2-[(1R,3S,4S)-2-{(2S)-2-[(methoxycarbonyl)amino]-3-methylbutanoyl}-2azabicyclo[2.2.1] hept-3-yl]-1H-benzimidazol-6-yl}-9H-fluoren-2-yl)-1H-imidazol-2-yl]-5-azaspiro[2.4] hept-5-yl}-3-methyl-

2.1 Mechanism of Action

Ledikast is a fixed-dose combination of ledipasvir and sofosbuvir which are directacting antiviral agents against the hepatitis C virus.

2.2 Pharmacodynamics

Cardiac Electrophysiology

Ledipasvir at a dose of 120 mg twice daily (2.67 times the maximum recommended dosage) and sofosbuvir 400 mg (maximum recommended dosage) and 1200 mg (three times the maximum recommended dosage) does not prolong QTc in clinical trials -

2.3 Pharmacokinetics

Absorption

The pharmacokinetic properties of ledipasvir, sofosbuvir, and the predominant circulating metabolite GS-331007 have been evaluated in healthy adult subjects and in subjects with chronic hepatitis C. Following oral administration, ledipasvir median peak concentrations were observed 4 to 4.5 hours post-dose. Sofosbuvir was absorbed quickly and the peak median plasma concentration was observed ~0.8 to 1 hour post dose. Median peak plasma concentration of GS-331007 was observed between 3.5 to 4 hours post-dose.

Based on the population pharmacokinetic analysis in HCV-infected subjects, geometric mean steady-state AUC0-24 for ledipasvir (N=2113), sofosbuvir (N=1542), and GS-331007 (N=2113) were 7290, 1320, and 12,000 ng-hr/mL. Steady-state Cmax for ledipasvir, sofosbuvir, and GS-331007 were 323, 618, and 707 ng/mL. Sofosbuvir and GS-331007 AUC0-24 and Cmax were similar in healthy adult subjects and subjects with HCV infection. Relative to healthy subjects (N=191)

Ledipasvir is >99.8% bound to human plasma proteins. After a single 90 mg dose of [14C]-ledipasvir in healthy subjects, the blood to plasma ratio of [14C]-radioactivity ranged between 0.51

Sofosbuvir is approximately 61-65% bound to human plasma proteins and the binding is independent of drug concentration over the range of 1 g/mL to 20 g/mL. Protein binding of GS-331007 was minimal in human plasma. After a single 400 mg dose of [14C]-sofosbuvir in healthy subjects, the blood to plasma ratio of 14C-radioactivity was approximately 0.7.

• Ledifos Tablets contains Ledipasvir and Sofosbuvir a formulation combination of anti-viral medications used in the treatment of Chronic Hepatitis C Virus (CHC) infection genotype 1
• Ledifos is a prescription medicine containing Ledipasvir (90mg) a viral NS5A inhibitor and Sofosbuvir (400mg) a nucleotide inhibitor of the viral RNA polymerase

With our in-depth knowledge and rich industry experience in this field, we are highly engaged in exporting, retailing, wholesaling and supplying a qualitative NATDAC Tablet for our esteemed clients. Processed employing advanced technology and using premium quality chemical compounds, offered tablet should only be used under proper medical guidance and advice. In order to maintain the effectiveness, our quality examiners test this tablet on various parameters. 

Features:

• Highly effective
• Long shelf life
• Balanced composition

Other Details: 28 Tablets.

• Ledihep is a prescription drug and should be used under proper medical guidance and advice
• The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers

• Accurate composition
• Hygienically packed
• Effectiveness

Other Details: 28 Tablets.

Additional Information:

• Item Code: 400mg

• 100% safe
• Safe to consume
• Free from impurities

Other Details: 28 Tablet