Rezolsta For Adolescent HIV Patients To Further Optimise Antiretroviral Regimens
The European Commission (EC) has approved an expansion of the indication for the anti-HIV combination drug Rezolsta (dalunavir/cobicistat) for use in adolescents with HIV who are 12 years of age and older and weigh ≥40kg.
The decision was based on data from a Phase III clinical study, which confirmed that Rezolsta has a comparable efficacy and safety profile to adults in adolescent patients, providing a more convenient first-line treatment option for this population.
Rezolsta: An Effective And Convenient Anti-HIV Regimen
Rezolsta is a fixed-dose combination of darunavir and cobicistat that should be taken orally only once a day with a meal.
Darunavir is a potent protease inhibitor (PI) that effectively inhibits HIV viral replication, while Cobicistat significantly increases the blood concentration and prolongs the duration of action of Darunavir by inhibiting the hepatic metabolising enzyme CYP3A4.
This indication expansion makes Rezolsta the first bicistat-based protease inhibitor combination approved for use in adolescents, filling a gap in treatment options for this age group.
Clinical Data Support Efficacy And Safety
The approval decision was based primarily on the results of the DIONE study.
This trial showed that Rezolsta demonstrated similar rates of virological suppression (HIV RNA <50 copies/ml) in adolescent patients as in adults and was well tolerated.
Common adverse reactions included diarrhoea, rash and headache, but most were mild to moderate.
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) noted, ‘Rezolsta’s simplified dosing regimen and reliable efficacy make it an important treatment option for adolescents with HIV.’
About The Current Situation Of HIV
According to the World Health Organisation (WHO), about 38 million people are now living with HIV globally, of which about 10% are children and adolescents. Although antiretroviral therapy (ART) has significantly improved prognosis, treatment coverage for adolescent patients remains lower than for adults.
Looking Ahead
The expansion of indications for Rezolsta is an important advance in the field of HIV treatment.
Researchers are exploring its use in combination with other long-acting agents, such as injectable caboterivir, to further streamline treatment regimens.
Rezolsta, one of the key drugs in the HIV treatment field, faces challenges from changing market demand and policy adjustments. In the future, its performance in the global market will depend on a number of factors, including clinical demand, competitive landscape and policy environment.
However, DengYue’s efforts to increase the affordability of the medicine are critical to ensuring that more patients benefit from it.
We welcome you to reach out to us to buy Darunavir/Cobicistat. DengYueMedicine is here to provide detailed medicine information, pricing, and support to ensure a smooth and reliable buying experience.
Feel free to contact us anytime to discuss your needs or ask any questions about the medicine.
Information from DengYueMed, China Drug Import and Export Wholesaler offers this information as a guide, not a substitute for professional medical advice. Consult your doctor before any treatment.
