The Chinese National Medical Products Administration (NMPA) has approved Gilead’s (GILD) HIV combination product Descovy®. In China, Descovy is to be indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) in adults and adolescents (aged 12 years and older with a body weight of at least 35 kg).
TAF, which is part of the combination treatment, is a novel, targeted prodrug of tenofovir that has demonstrated antiviral efficacy similar to Gilead’s TDF (tenofovir disoproxil fumarate 300 mg) but at one-tenth of the dose. Data show that because TAF has greater plasma stability and more efficiently delivers tenofovir to peripheral blood mononuclear cells compared to TDF, it can be given at a lower dose, resulting in less tenofovir in the bloodstream.
In clinical trials
TAF demonstrated improved kidney and bone laboratory safety parameters compared to TDF.
Professor Li Taisheng, Peking Union Medical College Hospital said, “As an effective HIV treatment backbone with a demonstrated renal and bone safety profile, Descovy may help support the long-term needs of a range of appropriate patients living with HIV.”
In 2017, there were 134,512 people newly diagnosed with HIV in China. The number of diagnoses has increased significantly in recent years, partially due to expanded screening. At the same time, the number of people living with HIV and receiving antiretroviral treatment has also increased steadily. The government of China has been providing free antiretroviral treatment to all persons living with HIV since 2003.
Trials that led to the approval
The approval of Descovy is supported by 144-week data from two pivotal Phase 3 studies in which the F/TAF-based regimen has met its primary objective of non-inferiority compared to an F/TDF-based regimen among treatment naïve adult patients. Tests of certain renal and bone laboratory parameters favored the F/TAF-based regimen over the F/TDF-based regimen.
The approval also is supported by a Phase 3 study (Study 109) evaluating the F/TAF-based regimen which is administered as Genvoya among virologically suppressed adult patients who switched from F/TDF-based regimens.
In the study
The F/TAF regimen was found to be statistically non-inferior to the F/TDF-based regimens and demonstrated improvements in certain bone and renal laboratory parameters compared to the F/TDF-based regimens. Additionally, the approval is supported by data from Phase 3 studies evaluating the F/TAF-based regimen (administered as Genvoya) among virologically suppressed adults with mild-to-moderate renal impairment and among treatment naïve adolescents.
Gilead is still the King of the HIV treatments and has contributed more than any other firm in improving the safety and the efficacy of the HIV treatments. The firm’s positive news is increasing. Its choices of acquisitions are confirming their values, be them in the HCV treatment world or in the CAR T immuno-oncology world, which has been increasingly proving its uniqueness in treating severe and advanced pretreated cancers that have failed many first- and second-line drugs.
The latest news of the firm’s decisions was the appointment of Daniel O’Day; a top executive of Roche to become the President and a CEO of Gilead. This is considered thrilling news for Gilead when considering the depth of O’Day’s experience in immuno-oncology.