Myhep All Tablet

Myhep All Tablet is a fixed-dose combination (FDC) direct-acting antiviral (DAA) medicine manufactured by Mylan Pharmaceuticals Private Limited, containing two active ingredients: Sofosbuvir 400mg (an NS5B polymerase inhibitor) and Velpatasvir 100mg (a pan-genotypic NS5A inhibitor). It is indicated for the treatment of chronic Hepatitis C Virus (HCV) infection in adults across all major genotypes (1–6), including patients with compensated or decompensated cirrhosis, HIV-HCV co-infection, and those who have previously failed treatment. Available from Shabbir Medical Hall at the best price in India, this genuine prescription tablet is available online with fast delivery nationwide.

BENEFITS: Myhep All Tablet provides a highly convenient once-daily, single-tablet regimen that achieves Sustained Virological Response (SVR12) — defined as undetectable HCV RNA 12 weeks after completing treatment — in over 95% of patients across all HCV genotypes in clinical trials. As a pan-genotypic combination, it eliminates the need for genotype testing before treatment initiation in many clinical settings, dramatically simplifying the treatment pathway. The 12-week standard treatment course offers patients a finite, highly tolerable cure for chronic hepatitis C. Mylan is a globally recognised manufacturer of affordable, high-quality generic medicines used widely in government and private HCV elimination programmes in India and internationally.

USAGE OVERVIEW: Myhep All Tablets are taken orally, once daily, with or without food, for 12 weeks (standard regimen for most patients without cirrhosis). Patients with decompensated cirrhosis may require 24 weeks of therapy and the addition of ribavirin, as directed by the specialist. The exact treatment duration must always be confirmed by the prescribing hepatologist or gastroenterologist.

SAFETY OVERVIEW: Myhep All is generally well-tolerated. Most common adverse effects include fatigue, headache, nausea, and insomnia. Serious drug interactions exist, particularly with amiodarone (risk of symptomatic bradycardia) and potent P-gp/CYP inducers such as rifampicin and St. John's Wort, which must be avoided.

Uses / Indications:

PRIMARY USES:
- Chronic Hepatitis C Virus (HCV) Infection (All Genotypes 1–6): Treatment of chronic HCV infection in adults; used to achieve Sustained Virological Response (SVR12 — undetectable HCV RNA at 12 weeks post-treatment), which is considered a functional cure; effective across genotypes 1, 2, 3, 4, 5, and 6 (pan-genotypic activity)
- HCV with Compensated Cirrhosis (Child-Pugh A): Effective in patients with compensated liver disease; standard 12-week regimen (±ribavirin depending on genotype and prior treatment history)
- HCV with Decompensated Cirrhosis (Child-Pugh B/C): Approved for use with ribavirin for 24 weeks; specialist hepatology supervision mandatory
- HIV-HCV Co-infection: Effective in adults with concurrent HIV-1 and HCV infection (appropriate antiretroviral drug interactions must be managed by HIV/hepatology specialist)

ADDITIONAL USES:
- HCV in Prior Treatment-Experienced Patients: Effective in patients who have failed prior interferon-based regimens, NS3/4A protease inhibitor-based regimens, or NS5A inhibitor-based regimens (specialist assessment required)
- HCV Post-Liver Transplant: Used in recurrent HCV infection after liver transplantation (specialist transplant hepatology guidance essential)
- Use within government National Viral Hepatitis Control Programme (NVHCP) for HCV elimination in India

Interactions / Warnings:

SYMPTOMATIC BRADYCARDIA WARNING — AMIODARONE COMBINATION
LIFE-THREATENING symptomatic bradycardia has been reported when sofosbuvir is combined with amiodarone (and potentially other antiarrhythmics affecting cardiac conduction) — some cases required pacemaker insertion; fatalities have been reported. This combination is ABSOLUTELY CONTRAINDICATED. If co-administration is unavoidable (no alternative): inpatient cardiac monitoring for the first 48 hours, then outpatient monitoring for at least 2 additional weeks; counsel patients on symptoms of bradycardia (dizziness, lightheadedness, near-syncope, syncope, chest pain) and to seek immediate emergency care.

HEPATITIS B VIRUS (HBV) REACTIVATION WARNING
HBV reactivation, including fulminant hepatitis and hepatic failure, has been reported in HCV/HBV co-infected patients starting DAA therapy. TEST ALL PATIENTS for HBV (HBsAg, anti-HBc, anti-HBs) before initiating Myhep All. If HBsAg-positive: refer to hepatologist for concurrent HBV antiviral therapy and monitoring. If anti-HBc-positive only (occult HBV): monitor HBV DNA and LFTs during and after DAA therapy.

RENAL IMPAIRMENT WARNING
Not recommended for patients with eGFR <30 ml/min or those on haemodialysis — limited safety and efficacy data; consult hepatologist. Velpatasvir is not renally cleared; sofosbuvir metabolite accumulates in severe renal impairment.

HEPATIC IMPAIRMENT
No dose adjustment required for mild-to-moderate hepatic impairment (Child-Pugh A/B) without ribavirin. Decompensated cirrhosis (Child-Pugh C): Use Myhep All + ribavirin × 24 weeks under specialist hepatology only; closely monitor for hepatic decompensation events.

DRIVING & MACHINERY
Fatigue and dizziness may impair driving — assess individually.

Pregnancy interaction:

PREGNANCY SAFETY:
- Myhep All Tablet is CONTRAINDICATED during pregnancy when used in combination with RIBAVIRIN — ribavirin is highly teratogenic (Category X); causes serious birth defects and foetal death
- Sofosbuvir and velpatasvir alone (Myhep All without ribavirin): limited human data; animal studies show no teratogenicity; however, use during pregnancy is NOT recommended unless clearly necessary and only under specialist supervision
- Women of childbearing potential must use two forms of effective contraception during therapy and for 6 months after ribavirin-containing treatment
- SOFOSBUVIR: excreted in breast milk in animal studies; avoid breastfeeding during therapy
- VELPATASVIR: limited data on excretion into breast milk; breastfeeding not recommended during treatment
- HCV treatment is typically deferred until after delivery in pregnant women unless clinical urgency outweighs risk — consult hepatologist and obstetrician

BREASTFEEDING:
- Breastfeeding is NOT recommended during Myhep All treatment or ribavirin combination therapy due to limited safety data and potential infant exposure
- Mothers who choose to breastfeed must discuss risks with hepatologist and paediatrician

CONTRACEPTION WARNING:
- Women of childbearing potential on ribavirin-containing regimens: mandatory use of two forms of non-hormonal or hormonal contraception (velpatasvir does NOT significantly affect hormonal contraceptive efficacy — unlike nevirapine-based HIV regimens); copper IUD, condoms, or barrier methods recommended
- Contraception must continue for 6 months after completing ribavirin-containing treatment

Expert advice:

PHARMACIST BEST PRACTICES:

1. SCREEN ALL PATIENTS FOR HEPATITIS B BEFORE DISPENSING — NON-NEGOTIABLE:
- Before the first dispense of Myhep All, confirm with the prescribing physician that the patient has been screened for HBV co-infection (HBsAg, anti-HBc). HBV reactivation during DAA therapy can cause fulminant hepatic failure and is life-threatening in unmonitored HBV/HCV co-infected patients. Do not assume this has been done — proactively ask. If the patient has not been screened, flag to the prescriber before dispensing.

2. THE AMIODARONE CONTRAINDICATION IS ABSOLUTE — ALWAYS CONDUCT A FULL DRUG HISTORY:
- Sofosbuvir + amiodarone co-administration has caused fatal bradycardia. Before dispensing Myhep All, take a complete cardiac medication history. Ask specifically about amiodarone, dronedarone, and other antiarrhythmics. If the patient is on amiodarone, DO NOT DISPENSE without urgent specialist hepatology and cardiology review. Counsel patients that even if they have recently stopped amiodarone (half-life of amiodarone is weeks), the risk may persist.

3. COMPLETING THE FULL 12-WEEK COURSE IS ESSENTIAL FOR CURE:
- Unlike antibiotics where patients often feel better and stop early, HCV DAA therapy requires strict course completion for SVR (cure). Counsel patients explicitly: completing every tablet for the full 12 weeks gives a >95% chance of curing hepatitis C; stopping early — even by a few days — risks treatment failure. Use tablet organisers and phone alarms. SVR12 (blood test at 12 weeks post-treatment) confirms cure — ensure patients attend this follow-up.

4. MANAGE PPI AND ANTACID TIMING CAREFULLY — VELPATASVIR ABSORPTION DEPENDS ON STOMACH ACIDITY:
- Velpatasvir absorption is pH-dependent. PPIs significantly reduce velpatasvir plasma concentrations when taken at different times. If the patient is on a PPI: advise them to take Myhep All simultaneously with the PPI dose WITH FOOD. Avoid high-dose PPIs where possible. Antacids should be separated by at least 4 hours. Patients often self-medicate with antacids — ask at every dispense.

5. RIBAVIRIN COMBINATION REGIMENS REQUIRE STRICT CONTRACEPTION COUNSELLING:
- For patients with decompensated cirrhosis requiring Myhep All + ribavirin: ribavirin is teratogenic Category X. Both male and female patients of reproductive age MUST use two forms of effective contraception during treatment and for 6 months after completion. Dispense ribavirin only with this counselling documented. Perform pregnancy test in women of childbearing potential before ribavirin initiation.

MONITORING ADVICE:
- HCV RNA (viral load): Baseline; at weeks 4, 12 (end of treatment), and 12 weeks post-treatment (SVR12 — confirms cure)
- Liver Function Tests (ALT, AST, bilirubin, albumin, INR): Baseline; at weeks 4 and 12; and at SVR12 — particularly important in cirrhotic patients
- Full Blood Count (CBC): Baseline; weeks 4 and 12 (particularly in ribavirin-containing regimens — monitor for haemolytic anaemia)
- Renal function (eGFR / serum creatinine): Baseline; particularly for patients on tenofovir-based HIV regimens or pre-existing renal impairment
- HBV monitoring (HBV DNA, LFTs): If anti-HBc positive, monitor throughout therapy and for 3 months post-treatment for HBV reactivation
- Cardiac monitoring: Resting heart rate and ECG at baseline if any history of arrhythmia or cardiac conduction disease

COMPLIANCE TIPS:
- Take at the same time each day — once daily dosing is straightforward; set one phone alarm
- Myhep All can be taken with or without food; however, if taking with PPIs, take together WITH food
- Use a weekly pill organiser — a 12-week supply (84 tablets) should be dispensed or organised clearly
- Carry a medication alert card listing Myhep All and the 12-week course end date for any emergency consultation
- Attend SVR12 blood test 12 weeks after completing treatment — this confirms cure

SAFETY TIPS:
- NEVER share Myhep All tablets — HCV genotype and treatment history are individual
- Inform ALL treating doctors (GP, cardiologist, dentist) that you are on DAA therapy before any new prescription
- Do NOT stop Myhep All without hepatologist approval — abrupt discontinuation risks SVR failure
- Avoid St. John's Wort and all undisclosed herbal remedies — they can reduce antiviral drug levels
- If you experience dizziness, slow heartbeat, or near-fainting — seek emergency medical care immediately (bradycardia risk)

Side Effects:

COMMON SIDE EFFECTS (≥1 in 10 people):
- Fatigue (most common — usually mild and manageable)
- Headache
- Nausea
- Insomnia (difficulty sleeping)
- Nasopharyngitis (common cold symptoms)
- Elevated bilirubin (particularly in patients with decompensated cirrhosis receiving ribavirin)
- Anaemia (primarily when ribavirin is co-administered; monitor haemoglobin)

LESS COMMON SIDE EFFECTS (1–10 in 100 people):
- Rash, pruritus (itching)
- Diarrhoea, vomiting, abdominal discomfort
- Decreased appetite
- Muscle aches (myalgia)
- Depression, irritability (more common with ribavirin combination)
- Elevated lipase (monitor for pancreatitis symptoms)

SERIOUS SIDE EFFECTS (contact your doctor immediately):
- Symptomatic Bradycardia (Heart Rate Slowing) — AMIODARONE INTERACTION: Serious and potentially life-threatening symptomatic bradycardia has been reported when sofosbuvir-based regimens are co-administered with amiodarone (and other antiarrhythmics) — ABSOLUTE CONTRAINDICATION; present to emergency care if palpitations, dizziness, or near-syncope occur
- Hepatic Decompensation: In patients with pre-existing cirrhosis, deterioration of liver function (jaundice, ascites, hepatic encephalopathy) may occur — monitor LFTs closely throughout therapy
- Severe Anaemia (Ribavirin-containing regimens): Haemolytic anaemia may require ribavirin dose reduction or discontinuation — monitor FBC regularly
- Reactivation of Hepatitis B Virus (HBV): HBV reactivation has been reported in HCV/HBV co-infected patients undergoing DAA therapy — screen all patients for HBV before initiating DAA treatment

EMERGENCY SIGNS — SEEK IMMEDIATE MEDICAL HELP:
- Slow or irregular heartbeat, dizziness, near-fainting (bradycardia — especially if on amiodarone)
- Jaundice, dark urine, severe abdominal pain (hepatic decompensation)
- Severe breathlessness, extreme fatigue (severe anaemia)
- Any signs of HBV flare in known HBV/HCV co-infected patients

How to use:

DOSAGE GUIDANCE (always as directed by your hepatologist / gastroenterologist):
- Standard Adult Dose (Non-Cirrhotic, All Genotypes): ONE tablet ONCE DAILY for 12 WEEKS
- Compensated Cirrhosis (Child-Pugh A): ONE tablet ONCE DAILY for 12 WEEKS (ribavirin may be added for genotype 3 with cirrhosis per specialist decision)
- Decompensated Cirrhosis (Child-Pugh B/C): ONE tablet ONCE DAILY + RIBAVIRIN for 24 WEEKS (specialist hepatology mandatory)
- HIV-HCV Co-infection (non-cirrhotic): ONE tablet ONCE DAILY for 12 WEEKS (manage antiretroviral interactions)
- Renal Impairment (eGFR <30 ml/min / dialysis patients): Not recommended — limited data; consult hepatologist
- Paediatric use: Not indicated for this formulation; paediatric HCV DAA regimens differ

ROUTE OF ADMINISTRATION:
- Oral (tablet) — swallow whole with water
- May be taken with or without food
- Do NOT crush, chew, or break tablets
- Take at the same time each day — strict adherence throughout the 12-week course is critical for SVR
- Completing the full course is essential; stopping early risks treatment failure and resistance

MISSED DOSE:
- If remembered within 18 hours of the scheduled time: take immediately and resume next dose at the normal time
- If more than 18 hours have passed: skip the missed dose and resume the regular schedule
- NEVER double up doses

STORAGE:
- Store below 30°C in a dry place, away from moisture and direct sunlight
- Keep in original container with lid tightly closed
- Keep out of reach of children
- Do not use after the expiry date printed on the label

How it works:

Myhep All Tablet contains two direct-acting antivirals (DAAs) with complementary mechanisms targeting the HCV replication cycle:

SOFOSBUVIR (SOF) — NS5B RNA-Dependent RNA Polymerase Inhibitor (Nucleotide Analogue):
- Sofosbuvir is a prodrug that is metabolised intracellularly to its active uridine triphosphate analogue (GS-461203)
- This active metabolite is incorporated into the nascent HCV RNA chain by the NS5B RNA-dependent RNA polymerase, causing chain termination and halting HCV RNA replication
- Sofosbuvir acts as a pan-genotypic HCV polymerase inhibitor with high genetic barrier to resistance at the NS5B level

VELPATASVIR (VEL) — NS5A Replication Complex Inhibitor (Pan-Genotypic):
- Velpatasvir binds to the HCV NS5A protein, a multifunctional non-structural protein essential for HCV RNA replication and virion assembly
- NS5A inhibition disrupts formation of the membrane-associated HCV replication complex and prevents HCV particle assembly and secretion
- Velpatasvir has pan-genotypic activity across HCV genotypes 1–6, including common resistance-associated variants

NET RESULT:
- Dual complementary attack on HCV NS5B (polymerase) and NS5A (replication complex) → profound suppression of HCV RNA replication → SVR12 (sustained virological response) achieved in >95% of patients → functional cure of chronic hepatitis C

KEY ADVANTAGES:
- Pan-genotypic — effective for all HCV genotypes 1–6 without requiring genotype testing in most cases
- Once-daily single tablet — simplified treatment regimen for 12 weeks
- High SVR12 rates (>95%) across treatment-naïve and treatment-experienced patients
- Well-tolerated safety profile — no interferon, no routine ribavirin for non-cirrhotic patients
- High genetic barrier to resistance at NS5B level (sofosbuvir)

Faq for medicine:

1. What is Myhep All Tablet used for?
Myhep All Tablet (Sofosbuvir 400mg + Velpatasvir 100mg) is a pan-genotypic direct-acting antiviral used to treat chronic Hepatitis C Virus (HCV) infection in adults across all genotypes (1–6), under specialist hepatologist supervision.

2. How does Myhep All Tablet work against Hepatitis C?
Sofosbuvir (NS5B inhibitor) blocks HCV RNA polymerase to halt viral replication, while Velpatasvir (NS5A inhibitor) disrupts the HCV replication complex and assembly. Together they achieve >95% SVR12 (cure rates) across all HCV genotypes.

3. What is the correct dose of Myhep All Tablet?
Standard dose: one tablet once daily for 12 weeks (non-cirrhotic patients, all genotypes). Decompensated cirrhosis requires Myhep All + ribavirin for 24 weeks. Always follow your hepatologist's prescription exactly for course duration and ribavirin addition.

4. What are the side effects of Myhep All Tablet?
Common: fatigue, headache, nausea, insomnia. Serious: symptomatic bradycardia (with amiodarone — absolute contraindication), HBV reactivation in co-infected patients, hepatic decompensation in cirrhotic patients. Screen for HBV before starting therapy.

5. Can I buy Myhep All Tablet online at the best price in India?
Yes. Buy Myhep All Tablet (28 tablets per bottle) online from Shabbir Medical Hall at 35% OFF MRP (Rs 10,664.00 vs Rs 16,406.20 per bottle). Valid hepatologist prescription required. Fast delivery across Hyderabad, Bangalore, Mumbai, Delhi, and Chennai.

Medicine interaction:

DRUG INTERACTIONS — MAJOR (CONTRAINDICATED OR AVOID):
- AMIODARONE (antiarrhythmic): ABSOLUTELY CONTRAINDICATED — risk of serious, symptomatic, and potentially fatal bradycardia with sofosbuvir-containing regimens; do not co-administer; if unavoidable, intensive cardiac monitoring in hospital required for first 48 hours
- RIFAMPICIN / RIFABUTIN (TB treatment): potent P-glycoprotein (P-gp) and CYP inducers — markedly reduce sofosbuvir and velpatasvir plasma levels, risking treatment failure; AVOID; use alternative anti-TB regimens after specialist review
- ST. JOHN'S WORT (Hypericum perforatum): potent P-gp/CYP inducer — markedly reduces velpatasvir levels; ABSOLUTELY CONTRAINDICATED
- CARBAMAZEPINE, PHENYTOIN, PHENOBARBITAL (antiepileptics): potent inducers — significantly reduce DAA levels; AVOID; consider alternative epilepsy management
- OXCARBAZEPINE: similar induction risk; AVOID

DRUG INTERACTIONS — CAUTION (DOSE ADJUSTMENT OR MONITORING):
- ANTACIDS (aluminium/magnesium hydroxide): separate administration by at least 4 hours from Myhep All
- PPIs (omeprazole, pantoprazole, etc.): high-dose PPIs reduce velpatasvir absorption — if PPI unavoidable, take Myhep All with food and administer PPI simultaneously (not 4 hours apart); use lowest effective PPI dose
- H2 RECEPTOR ANTAGONISTS (famotidine, ranitidine): separate from Myhep All by 12 hours; or take Myhep All simultaneously with H2RA and food
- HIV ANTIRETROVIRALS — INTERACTIONS VARY:
- Tenofovir alafenamide (TAF): velpatasvir may increase TAF exposure — use with caution and monitor renal function
- Efavirenz, etravirine, nevirapine: reduce velpatasvir levels — AVOID or use under specialist HIV/hepatology supervision
- Atazanavir (boosted): increases velpatasvir — monitor
- Ritonavir-boosted regimens: interactions complex — specialist assessment essential

SUPPLEMENT INTERACTIONS:
- St. John's Wort: CONTRAINDICATED — reduces antiviral levels and risks HCV treatment failure
- High-dose herbal and supplement regimens: always disclose to hepatologist; CYP/P-gp-active herbals can affect DAA pharmacokinetics