DORAVIRINE 100 mg Tablets

Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) – Antiretroviral Agent

ATC Code: J05AG06 | Prescription Only | Once-Daily Oral HIV Therapy

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Product Description:

Doravirine is a next-generation non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated for the treatment of HIV-1 infection in adults and adolescents. It acts by inhibiting HIV reverse transcriptase, a key enzyme in viral replication, thereby preventing conversion of viral RNA into DNA. Doravirine demonstrates activity against NNRTI-resistant strains, and has a high genetic barrier to resistance, making it a preferred NNRTI in modern HIV regimens.

Doravirine 100 mg is typically co-administered with two NRTIs, or it can be part of a fixed-dose triple therapy (such as doravirine/lamivudine/tenofovir DF). It offers once-daily dosing without food restrictions and is generally well tolerated.

Available Presentation:

• Strength: 100 mg per tablet
• Formulation: Film-coated oral tablet
• Packaging: Bottle of 30 tablets (once-daily dosing)
• Route of Administration: Oral, with or without food
• Storage Conditions: Store below 30°C; protect from moisture

Uses:

• First-line or switch option for HIV-1 infected adults and adolescents ≥35 kg
• Used as part of combination antiretroviral therapy (cART) with two nucleoside reverse transcriptase inhibitors (NRTIs)
• Considered in:
  • Patients intolerant to integrase inhibitors (INSTIs)
  • Individuals requiring NNRTI-based regimens with improved tolerability
  • Maintenance regimens for virally suppressed patients seeking simplified therapy

Indications:

• HIV-1 infection in treatment-naïve or virologically suppressed adults and adolescents ≥35 kg
• Effective in patients with resistance to first-generation NNRTIs such as efavirenz or nevirapine
• May be used in post-exposure prophylaxis (PEP) protocols, when INSTIs are contraindicated

Regulatory and Safety Profile:

• ATC Code: J05AG06
• Pharmacologic Class: Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI)
• Pregnancy Category: B – Limited data, no evidence of teratogenicity; consult treatment guidelines
• Common Adverse Effects: Nausea, dizziness, abnormal dreams, headache, fatigue
• Serious Risks: Hepatic transaminase elevations (especially in HBV/HCV co-infection), hypersensitivity
• Contraindications: Co-administration with strong CYP3A inducers (e.g., rifampin, carbamazepine)
• Monitoring Parameters: HIV viral load, liver enzymes, renal function, CNS symptoms (rare)

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