EFVIR-EM

Emtricitabine (200mg) + Tenofovir disoproxil fumarate (300mg)
Price: ₹750 - ₹1,050 for 30 tablets (MRP). Often supplied at lower cost through NACO.
Mfr: Hetero Drugs Ltd. | Form: Tablet

📋 Clinical Overview

A fixed-dose combination (FDC) of two nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) used primarily for the treatment of HIV-1 infection and for pre-exposure prophylaxis (PrEP) against HIV. Emtricitabine is a cytosine analogue, and tenofovir disoproxil fumarate (TDF) is an acyclic nucleoside phosphonate diester analogue of adenosine monophosphate. This combination is a cornerstone of first-line antiretroviral therapy (ART) in India and globally, known for its high efficacy, tolerability, and once-daily dosing.

💊 Dosage & Administration

Adult: One tablet (containing Emtricitabine 200mg + Tenofovir disoproxil fumarate 300mg) orally, once daily, with or without food.

Note: Swallow the tablet whole with water. Can be taken with or without food, but a high-fat meal increases tenofovir absorption. For PrEP, adherence is critical for effectiveness. Must be taken daily, not just before/after sexual activity.

⚠️ Contraindications

  • Hypersensitivity to emtricitabine, tenofovir disoproxil fumarate, or any component of the formulation.
  • Concomitant use with other medicinal products containing emtricitabine, tenofovir disoproxil fumarate, or tenofovir alafenamide.
  • For PrEP: Use in individuals with unknown or positive HIV-1 status. PrEP must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiation and at least every 3 months during use.

🔬 Mechanism of Action

The combination inhibits the reverse transcriptase enzyme of HIV-1, a critical enzyme for viral replication. Emtricitabine and tenofovir are both analogues of natural nucleosides/nucleotides. They are phosphorylated intracellularly by cellular kinases to their active diphosphate (Emtricitabine 5'-triphosphate, FTC-TP) and diphosphate (Tenofovir diphosphate, TFV-DP) forms, respectively. These active metabolites compete with the natural substrates (deoxycytidine 5'-triphosphate for FTC-TP and deoxyadenosine 5'-triphosphate for TFV-DP) for incorporation into the growing viral DNA chain by HIV-1 reverse transcriptase. Once incorporated, they act as chain terminators because they lack the 3'-hydroxyl group needed to form the next phosphodiester bond, thereby halting viral DNA synthesis and replication.

🤕 Side Effects

  • Headache
  • Diarrhea
  • Nausea
  • Fatigue
  • Dizziness
  • Rash
  • Abdominal pain
  • Flatulence
  • Insomnia
  • Abnormal dreams

🤰 Special Populations

Pregnancy: Pregnancy Category B. No adequate and well-controlled studies in pregnant women. Emtricitabine and tenofovir cross the placenta. The combination is recommended for use in pregnant individuals living with HIV as part of a complete ART regimen to prevent mother-to-child transmission. The Antiretroviral Pregnancy Registry monitors outcomes. Benefits generally outweigh risks.

Driving: Dizziness and fatigue have been reported. Patients should be cautioned about operating machinery or driving if they experience these effects.

🔄 Drug Interactions

Didanosine (ddI)Increased didanosine concentrations and potential for didanosine-related adverse effects (pancreatitis, neuropathy). Tenofovir may increase ddI levels.Major
Adefovir dipivoxilAdditive nephrotoxicity potential.Major
Other nephrotoxic drugs (e.g., Aminoglycosides, Amphotericin B, Foscarnet, Ganciclovir, Vancomycin, NSAIDs like Ibuprofen)Increased risk of renal impairment.Major
Probenecid, CidofovirMay increase tenofovir concentrations by competing for renal tubular secretion.Moderate
Ledipasvir/Sofosbuvir or other HCV regimens containing VelpatasvirMay increase tenofovir exposure; monitor for tenofovir-associated adverse effects, especially renal.Moderate
Rifampin, RifabutinMay decrease tenofovir concentrations slightly; not considered clinically significant for efficacy.Minor
Atazanavir (boosted with Ritonavir)Increases tenofovir exposure. Monitor for renal toxicity.Moderate

🔁 Alternatives to EFVIR-EM

Same composition (Emtricitabine (200mg) + Tenofovir disoproxil fumarate (300mg)), different brands:

Tenvir-EM Ricovir-EM Tafdon-EM Teno-EM Tavin-EM