DARUNAVIR 800 mg + COBICISTAT Tablets

Protease Inhibitor (PI) + Pharmacokinetic Enhancer – Fixed-Dose Antiretroviral Therapy

ATC Code: J05AR20 | Prescription Only | WHO-Listed Second-Line HIV Regimen

---

Product Description:

Darunavir-Cobicistat is a fixed-dose combination (FDC) antiretroviral tablet containing:

• Darunavir (800 mg): A second-generation HIV-1 protease inhibitor (PI) that prevents the cleavage of viral polyproteins, resulting in immature, noninfectious viral particles.
• Cobicistat (150 mg): A CYP3A4 inhibitor that acts as a pharmacokinetic booster to enhance darunavir plasma levels without antiretroviral activity.

This once-daily formulation offers a simplified alternative to ritonavir-boosted PIs and is co-formulated for improved adherence in adult patients with HIV-1 infection. Darunavir offers a high genetic barrier to resistance, making it a preferred choice in second-line or salvage regimens.

Available Presentation:

• Strength: Darunavir 800 mg + Cobicistat 150 mg per tablet
• Formulation: Film-coated tablet
• Packaging: Bottle of 30 tablets (once-daily dosing)
• Route of Administration: Oral, with food
• Storage Conditions: Store below 30°C; keep tightly closed in original container

Uses:

• Used as a once-daily complete boosted PI component in ART
• Preferred for:
  • Patients failing NNRTI- or INSTI-based regimens
  • Individuals with resistance mutations requiring a PI-based regimen
  • Settings where ritonavir boosting is unavailable or poorly tolerated
• Often co-administered with a dual NRTI backbone (e.g., tenofovir + lamivudine or abacavir + lamivudine)

Indications:

• HIV-1 infection in treatment-naïve or treatment-experienced adults without darunavir resistance-associated mutations
• WHO-recommended second-line or alternative first-line ART in:
  • Patients with contraindications to dolutegravir
  • Regions with limited access to integrase inhibitors
  • Patients requiring a robust PI-based regimen with high resistance barrier

Regulatory and Safety Profile:

• ATC Code: J05AR20
• Pharmacologic Class: HIV-1 Protease Inhibitor (boosted)
• Pregnancy Category: C – Not recommended in pregnancy due to altered pharmacokinetics; use alternatives if possible
• Common Adverse Effects: Diarrhea, nausea, rash, headache, abdominal pain
• Serious Risks: Hepatotoxicity, severe cutaneous reactions (e.g., Stevens-Johnson syndrome), extensive drug-drug interactions due to CYP3A inhibition
• Contraindications: Severe hepatic impairment; use with drugs highly dependent on CYP3A clearance (e.g., alfuzosin, amiodarone, rifampin)
• Monitoring Parameters: Liver enzymes, lipid panel, serum creatinine (due to cobicistat), ECG in high-risk patients, and potential drug interactions

---

For ARV program tenders, WHO PQ sourcing, or hospital-based HIV protocol supply, contact info@panamfarma.com.