From the FDA Drug Label
The weight-based dose in antiretroviral treatment-naïve pediatric patients or antiretroviral treatment-experienced pediatric patients with no darunavir resistance associated substitutions is darunavir 35 mg/kg once daily with ritonavir 7 mg/kg once daily The weight-based dose in antiretroviral treatment-experienced pediatric patients with at least one darunavir resistance associated substitution is darunavir 20 mg/kg twice daily with ritonavir 3 mg/kg twice daily Pediatric patients weighing at least 15 kg can be dosed with darunavir oral tablet(s) or suspension using the following table: Table 2: Recommended Dose for Pediatric Patients Weighing 10 kg to Less Than 15 kg Who are Treatment-Naïve or Treatment-Experienced with No Darunavir Resistance Associated Substitutions Table 3: Recommended Dose for Pediatric Patients Weighing At Least 15 kg Who are Treatment-Naïve or Treatment-Experienced with No Darunavir Resistance Associated Substitutions Table 4: Recommended Dose for Pediatric Patients Weighing 10 kg to Less Than 15 kg Who are Treatment-Experienced with At Least One Darunavir Resistance Associated Substitution Table 5: Recommended Dose for Pediatric Patients Weighing At Least 15 kg Who are Treatment-Experienced with At Least One Darunavir Resistance Associated Substitution
The dosage of antiretroviral therapy for pediatric patients is as follows:
- For treatment-naïve pediatric patients or treatment-experienced pediatric patients with no darunavir resistance associated substitutions:
- Darunavir 35 mg/kg once daily with ritonavir 7 mg/kg once daily for patients weighing at least 10 kg but less than 15 kg
- Darunavir 600 mg with ritonavir 100 mg once daily for patients weighing at least 15 kg but less than 30 kg
- Darunavir 675 mg with ritonavir 100 mg once daily for patients weighing at least 30 kg but less than 40 kg
- Darunavir 800 mg with ritonavir 100 mg once daily for patients weighing at least 40 kg
- For treatment-experienced pediatric patients with at least one darunavir resistance associated substitution:
- Darunavir 20 mg/kg twice daily with ritonavir 3 mg/kg twice daily for patients weighing at least 10 kg but less than 15 kg
- Darunavir 375 mg with ritonavir 48 mg twice daily for patients weighing at least 15 kg but less than 30 kg
- Darunavir 450 mg with ritonavir 60 mg twice daily for patients weighing at least 30 kg but less than 40 kg
- Darunavir 600 mg with ritonavir 100 mg twice daily for patients weighing at least 40 kg 1
From the Research
Antiretroviral therapy (ART) for HIV typically consists of a combination of three drugs from at least two different drug classes, with a common first-line regimen including an integrase strand transfer inhibitor (INSTI) such as dolutegravir, combined with two nucleoside reverse transcriptase inhibitors (NRTIs) like tenofovir alafenamide/emtricitabine (TAF/FTC). The most recent and highest quality study 2 provides an overview of current treatments for patients with HIV, which are not only effective at controlling viral replication but also associated with a more favorable adverse reaction profile. Some key points to consider when initiating ART include:
- Starting treatment as soon as possible after diagnosis, regardless of CD4 count, to prevent disease progression and transmission 3, 4
- Selecting a regimen based on resistance test results, dosing frequency, pill burden, adverse toxic effect profiles, comorbidities, and drug interactions 5
- Monitoring viral load, CD4 count, and potential side effects regularly to manage therapy effectively 3, 4
- Adjusting dosages for patients with kidney dysfunction, liver disease, or drug interactions 3, 4 Specific dosages may include dolutegravir 50mg once daily with TAF/FTC 25/200mg once daily, or bictegravir/TAF/FTC as a single tablet (50/25/200mg) once daily. Alternative regimens may include protease inhibitors (like darunavir 800mg with ritonavir 100mg once daily) or non-nucleoside reverse transcriptase inhibitors (like efavirenz 600mg once daily). It is essential to note that ART must be taken consistently every day for life to maintain viral suppression. In terms of monitoring, initial laboratory evaluation includes CD4+ cell count, plasma HIV-1 RNA, and testing for HIV reverse transcriptase and protease resistance mutations 3. Regular monitoring of viral load, CD4 count, and potential side effects is essential for managing therapy effectively. Overall, the goal of ART is to achieve and maintain viral suppression, prevent disease progression, and reduce the risk of transmission.