Description:

MyHep Sofosbuvir Tablets IP 400mg (28 tabs) by Mylan is a generic direct-acting antiviral (DAA) medication used in combination with other antiviral drugs to treat chronic hepatitis C virus (HCV) infection. It inhibits the HCV NS5B RNA-dependent RNA polymerase, preventing viral replication and leading to high cure rates (sustained virologic response) when used in appropriate regimens for various genotypes. It is a key component in interferon-free therapies for HCV, often combined with ribavirin, daclatasvir, ledipasvir, or others depending on genotype, cirrhosis status, and prior treatment history.

Prescription: Prescription-only (Rx). Requires a doctor’s prescription (typically from a hepatologist or infectious disease specialist) with genotype testing, liver assessment (e.g., FibroScan), and monitoring. In Ghana, it is regulated and available through pharmacies or specialist clinics.

Therapeutic Category:

Antiviral / Direct-acting antiviral (DAA) / NS5B polymerase inhibitor (for chronic hepatitis C treatment).

Active Ingredients/Composition:

Each film-coated tablet contains: Sofosbuvir 400 mg. Excipients: Standard film-coating agents, lactose (in some formulations), microcrystalline cellulose, etc. (refer to label for full list).

Vitamins: None.

Minerals: None.

Variant: 400 mg strength tablets (standard adult dose; 28-tablet pack for a 4-week course when used in regimens of 12-24 weeks; film-coated for oral use).

Consume Type:

Oral (tablet; swallow whole with water; can be taken with or without food).

Directions/Usage: Adults: One 400 mg tablet once daily, in combination with other antivirals (e.g., ribavirin ± peginterferon in older regimens, or DAAs like daclatasvir/ledipasvir/velpatasvir in modern pangenotypic regimens). Duration: Typically 12 weeks (some genotypes/cirrhosis cases 24 weeks); exact regimen/genotype-specific per WHO/Ghana guidelines or specialist. Take at the same time daily; if vomiting within hours, consult doctor. Complete full course even if symptoms improve. Not monotherapy—always combined. Monitor viral load, liver function, and side effects regularly.

Common Side Effects:

• Fatigue/tiredness
• Headache
• Nausea
• Insomnia
• Anaemia (especially with ribavirin)
• Decreased appetite, irritability, diarrhoea Most are mild and transient; serious rare effects include worsening liver issues (jaundice, abdominal pain) or reactivation of hepatitis B (screen before starting). Seek immediate help for severe symptoms like rash, breathing difficulty, or signs of liver failure.

Package Type:

Blister pack or bottle containing 28 film-coated tablets (often in a carton box with desiccant).

Storage Advice: Store at room temperature (below 30°C), in a cool, dry place away from direct sunlight, heat, and moisture. Keep in original packaging and out of reach of children.

Safety Advice:

• Must be used in combination regimens—do not use alone.
• Screen for HBV co-infection (risk of reactivation—may require HBV treatment).
• Caution in severe renal impairment (limited data; monitor closely).
• Not recommended in pregnancy (use effective contraception; teratogenic risk with ribavirin if combined).
• Consult doctor if breastfeeding, elderly, or on interacting drugs (e.g., amiodarone—bradycardia risk; certain anticonvulsants reduce efficacy).
• Regular blood tests required (HCV RNA, LFTs, CBC).
• Avoid alcohol; maintain healthy liver habits.
• Report any new/worsening symptoms promptly.

Product Substitutes: Other sofosbuvir 400 mg generics: Sovaldi (original Gilead, less common now), Hepcinat, Sofovir, Resof, or combinations like MyHep LVIR (ledipasvir/sofosbuvir), MyHep All (velpatasvir/sofosbuvir). Pangenotypic options (e.g., sofosbuvir/velpatasvir generics) may replace standalone sofosbuvir in many regimens—consult specialist per local HCV guidelines (e.g., Ghana National Hepatitis Programme).

Manufacturer/Marketer:

Mylan Pharmaceuticals Private Limited (now part of Viatris following merger; originally launched by Mylan in India under licensing from Gilead).

Country of Origin:

India.