Gilead Sciences, Inc. (NASDAQ: GILD) announced on 8/6/18 that the China National Drug Administration (CNDA) has approved Genvoya (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg or E/C/F/TAF) for the treatment of HIV-1 infection. Genvoya is the first TAF-based single tablet regimen for the treatment of HIV to be approved in China.
Genvoya is indicated in China as a complete regimen for the treatment of adults and adolescents (aged 12 years and older with a body weight of at least 35 kg) infected with HIV-1 without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir. In the United States, Genvoya has a boxed warning in its product label regarding the risks of post treatment acute exacerbation of hepatitis B. Further important safety information, adverse drug reactions and drug interactions are listed below.
In 2017, there were approximately 140,000 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. In 2003, the government of China began providing free antiretroviral treatment to all persons living with HIV.
“With access to appropriate treatment, people living with HIV have the potential to live nearly as long as the general population. Because of this, they may face increased risk of age- and treatment-related comorbidities, which means long-term health should be a priority when caring for patients with HIV,” said Professor Li Taisheng, Peking Union Medical College Hospital. “In clinical trials, Genvoya has demonstrated long-term viral suppression through 144 weeks and has a safety profile that may be appropriate for a broad range of people living with HIV.”
Genvoya has become a standard HIV-1 treatment in the US and Europe. It has already become the most-prescribed regimen for both treatment-naïve and switch patients, since its launch in November 2015. Additionally it is listed as a preferred regimen in several HIV guidelines.