China National Drug Administration (CNDA) has approved Gilead Sciences’ 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.
“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.”
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.
“Gilead supports China’s efforts to address the HIV epidemic and we are pleased to offer Genvoya as a new treatment option for people living with HIV in China,” said John F. Milligan, PhD, Gilead’s president and CEO. “As part of our TAF-based portfolio of treatments, we believe Genvoya’s safety and efficacy profile may help to address the long-term health needs of China’s HIV patient population.”
Genvoya was studied in a Phase 3 HIV clinical program in more than 3,500 patients across 21 countries, including treatment-naïve, virologically suppressed, renally impaired and adolescent patients. The approval is supported by 144-week data from two Phase 3 double-blind studies (Studies 104 and 111) among 1,733 treatment-naïve patients in which the regimen met the primary endpoint of non-inferiority compared to Gilead’s Stribild® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or E/C/F/TDF) at Week 48. At Week 48, 92.4 percent (n=800/866) of patients taking Genvoya and 90.4 percent (n=784/867) of patients taking Stribild achieved HIV-1 RNA levels less than 50 copies/mL
Additionally, the approval is supported by a Phase 3 study (Study 109) evaluating Genvoya among virologically suppressed patients who switched from TDF-based regimens. The study enrolled 1,436 subjects and 1,196 had reached the 48-week time point at the time of filing. Among those patients, Genvoya was found to be statistically non-inferior to the TDF-based regimens based on the percentages of patients with HIV-1 RNA levels less than 50 copies/mL at Week 48. Patients receiving Genvoya also demonstrated improvements in certain bone and renal laboratory parameters compared to those treated with the TDF-based regimens. Finally, data from Phase 3 studies evaluating Genvoya among adolescents and adults with mild-to-moderate renal impairment supported the approval.
(Source: Gilead Sciences, Inc.)
Filed Under: Drug Discovery