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Darunavir is used for the treatment of human immunodeficiency virus (HIV‑1) infection in adults and pediatric patients (≥3 years of age, ≥15 kg). The medication is a protease inhibitor that blocks HIV‑1 replication by inhibiting the viral protease enzyme, reducing viral load and increasing CD4 cell counts.
The usual dosage of Darunavir is 800 mg taken once daily (in combination with 100 mg ritonavir or 150 mg cobicistat) for treatment‑naïve patients, or 600 mg twice daily (with 100 mg ritonavir) for treatment‑experienced patients.
The administration form is tablets (75 mg, 150 mg, 600 mg, 800 mg) or an oral suspension (100 mg/mL).
The effect of the medication begins within several weeks, with maximal viral suppression typically achieved after 24‑48 weeks of combination therapy.
The duration of action is approximately 24 hours (once‑daily regimen) or 12 hours (twice‑daily regimen).
Alcohol consumption is not recommended during treatment.
The most common side effects are diarrhea, nausea, and headache.
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Basic Darunavir Information

• INN (International Nonproprietary Name): Darunavir
• Brand names available in USA: Prezista®
• ATC Code: J05AE10
• Forms and dosages: Tablets – 75 mg, 150 mg, 600 mg, 800 mg; oral suspension – 100 mg/mL
• Manufacturers in USA: Janssen Pharmaceuticals, Inc. (a subsidiary of Johnson & Johnson)
• Registration status in USA: Approved by FDA
• OTC / Rx classification: Prescription only (Rx)

Mechanism and Pharmacology

Darunavir is a non‑peptidic protease inhibitor that specifically inhibits the dimerization and catalytic activity of HIV‑1 protease. By blocking the cleavage of viral Gag‑Pol polyproteins into functional proteins, darunavir prevents the maturation of infectious viral particles. It is highly active against both wild‑type and protease inhibitor‑resistant HIV‑1 strains. Darunavir is always coadministered with a pharmacokinetic booster (ritonavir or cobicistat) to increase its plasma half‑life and bioavailability. It is metabolized primarily by CYP3A4.

Indications and Usage

Darunavir is indicated in combination with ritonavir or cobicistat and other antiretroviral agents for the treatment of HIV‑1 infection in adults and pediatric patients aged 3 years and older weighing at least 15 kg. It is used for both treatment‑naïve and treatment‑experienced patients, including those with prior virologic failure and multiple protease inhibitor‑associated resistance mutations. Darunavir is also indicated for pregnant women (when benefits outweigh risks) and for patients with HIV‑1 coinfection with hepatitis B or C.

Critical Warnings and Limitations

High‑Risk Groups
Elderly: No specific dose adjustment; use with caution due to age‑related renal or hepatic decline and increased risk of comorbidities.
Pregnancy: Darunavir should be used during pregnancy only if clearly needed. Pregnant women may require increased dosing (600 mg twice daily with ritonavir 100 mg twice daily) during the second and third trimesters due to altered pharmacokinetics.
Breastfeeding: HIV‑infected mothers should not breastfeed to avoid postnatal transmission of HIV. Darunavir is present in human milk; breastfeeding is not recommended.

Activity Interactions
Driving: May cause dizziness or fatigue – use caution when operating vehicles or machinery.
Alcohol: Avoid alcohol consumption as it may increase risk of liver toxicity and worsen side effects.

Dosage Guide

Standard Regimens
Treatment‑naïve adults and children (≥3 years, ≥15 kg):
- Darunavir 800 mg once daily + ritonavir 100 mg once daily (or cobicistat 150 mg once daily).
Treatment‑experienced adults (no darunavir resistance‑associated mutations):
- Darunavir 800 mg once daily + ritonavir 100 mg once daily.
Treatment‑experienced adults with at least one darunavir resistance‑associated mutation or unknown mutation status:
- Darunavir 600 mg twice daily + ritonavir 100 mg twice daily.
Pregnant women (second and third trimester):
- Darunavir 600 mg twice daily + ritonavir 100 mg twice daily (or 800/100 mg once daily if already virologically suppressed).
Treatment is always used in combination with other antiretroviral agents (e.g., tenofovir, emtricitabine, dolutegravir).

Special Populations
Renal impairment: No dose adjustment for mild to severe renal impairment (including ESRD on hemodialysis). For patients on hemodialysis, administer after dialysis.
Hepatic impairment: For mild (Child‑Pugh A) or moderate (Child‑Pugh B) impairment, no dose adjustment; for severe (Child‑Pugh C), darunavir is not recommended.
Pediatric: Dosing based on body weight and age; refer to specific pediatric guidelines.

Side Effects and Contraindications

Common side effects:
- Diarrhea
- Nausea
- Headache
- Abdominal pain
- Rash (usually mild to moderate)
- Increased liver enzymes (ALT, AST)
- Lipodystrophy (long‑term)

Serious side effects requiring medical attention:
- Severe skin reactions (Stevens‑Johnson syndrome, toxic epidermal necrolysis, DRESS syndrome)
- Hepatotoxicity (severe liver injury, especially in patients with underlying hepatitis B or C)
- Hyperglycemia, new‑onset diabetes, or diabetic ketoacidosis
- Pancreatitis
- Immune reconstitution syndrome (when starting therapy)
- Severe allergic reactions (angioedema, bronchospasm)

Absolute contraindications:
- Hypersensitivity to darunavir or any excipient
- Severe hepatic impairment (Child‑Pugh C)
- Coadministration with drugs that are highly dependent on CYP3A4 for clearance and for which elevated plasma levels are associated with serious events (e.g., alfuzosin, rifampin, ergot derivatives, cisapride, St. John’s wort, lovastatin, simvastatin, sildenafil for pulmonary hypertension, triazolam, midazolam [oral]).

Drug Interactions

Significant interactions include:
- Strong CYP3A4 inducers (rifampin, carbamazepine, phenytoin, phenobarbital, St. John’s wort): Decrease darunavir levels – contraindicated.
- HMG‑CoA reductase inhibitors (lovastatin, simvastatin): Contraindicated due to increased statin levels and risk of myopathy. Atorvastatin, rosuvastatin, pravastatin may be used with caution and dose adjustments.
- Antiarrhythmics (amiodarone, bepridil, lidocaine, quinidine): Monitor levels; increased risk of toxicity.
- Warfarin: Monitor INR; darunavir may affect anticoagulation.
- Oral contraceptives: Reduced efficacy of ethinyl estradiol; alternative or additional contraception recommended.
- Antacids and H2 blockers: Separate administration by at least 2 hours to avoid reduced darunavir absorption.
- Other protease inhibitors, NNRTIs, and integrase inhibitors: Complex interactions; always consult prescribing information.

Practical Guidelines

Administration
Take Darunavir with ritonavir (or cobicistat) exactly as prescribed. Swallow tablets whole with a meal (food enhances absorption). Do not crush or chew. Oral suspension should be shaken well before use and taken with food. Missed dose: if within 6 hours of scheduled time, take immediately; if more than 6 hours, skip the missed dose and resume regular schedule. Do not double dose.

Monitoring
Regular blood tests required before and during treatment:
- HIV‑1 RNA viral load (every 3‑6 months)
- CD4 cell count (every 3‑6 months)
- Liver function tests (ALT, AST, bilirubin) at baseline and periodically
- Renal function (creatinine, eGFR)
- Fasting glucose and lipid profile (due to metabolic effects)
- Pregnancy test (if applicable)
- Skin examination for rash (especially during first 2‑4 weeks)

Storage
Store at room temperature (20‑25°C / 68‑77°F), excursions permitted to 15‑30°C (59‑86°F). Protect from moisture and heat. Keep tablets in original container, tightly closed. Oral suspension may be stored at room temperature; do not freeze.

Alternative Medications

• Atazanavir (Reyataz): Protease inhibitor with once‑daily dosing, but requires acid for absorption and has higher risk of hyperbilirubinemia.
• Lopinavir/ritonavir (Kaletra): Older PI; higher pill burden and more gastrointestinal side effects.
• Ritonavir (Norvir): Used only as a booster, not as a standalone antiviral.
• Dolutegravir (Tivicay): Integrase strand transfer inhibitor with high efficacy and minimal interactions, often preferred over PIs.
• Bictegravir (in Biktarvy): Integrase inhibitor with once‑daily single tablet regimen.

Clinical Effectiveness

In clinical trials (ARTEMIS, TITAN, ODYSSEY), darunavir/ritonavir demonstrated superior virologic suppression compared to other protease inhibitors. In treatment‑naïve patients, darunavir/ritonavir achieved viral load

Important: Darunavir requires medical supervision and should only be used under prescription. Do not stop treatment without consulting your doctor. Missing doses can lead to viral rebound and development of resistance. Regular monitoring for rash, liver toxicity, and drug interactions is essential. If you experience severe rash, jaundice, or signs of allergic reaction, seek immediate medical attention.

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