Janssen announced the approval of the FDA for the antiviral drug Symtuza
On Tuesday, July 17th, the pharmaceutical company Janssen, part of the Johnson & Johnson structure, issued a statement approving the drug for the treatment of HIV-1 Symtuza by the US Food and Drug Administration (FDA). A drug that is a combination of darunavir / cobicystate / emtricitabine / tenovovir alaphenamide is intended for patients who have not previously received treatment or who have had other therapy.
Symtuza is the only drug on the basis of darunavir, available in the form of a single tablet and is intended for the treatment of HIV-1 in adults and adolescents from the age of 12.
"As with clinicians, we do not always have a complete picture of the patient's health and the risks that threaten him. In the Phase III clinical trials, Symtuza proved to be quite successful, helping all those who started therapy to achieve an undetectable viral load", said Dr. Joseph Eron from the AIDS Center of the University of North Carolina.
Among them, the scientist noted, there were those who had not previously taken ARVT, and those who before the Symtuza achieved suppression of HIV.
It should be noted that the guidelines of the US Department of Health and Human Services for patients who do not take ARVT in certain clinical situations, including when they have problems with adherence or data on adherence are unknown, treatment methods based on darunavir are recommended.
Also, Dr. Aaron continued, many people living with HIV persist in adhering to ARV therapy that does not work, which can lead to the development of drug resistance and cause subsequent exclusion from the schemes of one or even several drugs of a certain class.
Symtuza received FDA approval based on two 48-week Phase III clinical trials that assessed the safety and efficacy of the drug compared to the control regimen in adults without previous history of ARV therapy (AMBER) and among adults with suppressed viral load (EMERALD). The results of both studies demonstrated that Symtuza is effective and well tolerated: in 95%, an undetectable viral load is achieved or maintained (HIV-1 RNA <50 k / ml).
The recommended dosage of Symtuza is one tablet once a day with food.
The drug is not recommended for patients with creatinine clearance below 30 ml per minute or with severe hepatic impairment.
According to information published by the FDA, patients should be checked for hepatitis B virus (HBV) before or at the beginning of Symtuza treatment and no complaints about kidney function.
We add that the drug Symtuza has already been approved by the European Commission (EC) and Health Canada for the treatment of HIV-1 in adults and adolescents aged 12 years and with a body weight of at least 40 kg.
The supplier of active substances, cobicistat, emtricitabine and tenovovir alafenamide is Gilead Sciences, but Janssen is responsible for the production, registration, distribution and commercialization of this scheme under the world license agreement.