China’s National Medicinal Products Administration approved Gilead’s Truvada
Gilead has announced that China’s National Medicinal Products Administration has approved Truvada (emtricitabine 200mg/tenofovir disoproxil fumarate 300 mg, FTC/TDF) for pre-exposure prophylaxis. The drug is indicated to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents weighing a minimum of 35 kgs. Individuals must be HIV-1 negative before initiating the treatment with Truvada.
The drug has been earlier approved in the combination of other antiretrovirals for treating HIV-1 infection. It has been approved for adults and pediatrics aged 12 years and above.
China’s National Health Commission reported 131,000 new HIV infections between January and October 2019. Sexual transmission was the primary mode of transmission.
World Health Organisation has recommended the use of pre-exposure prophylaxis in addition to safe sex in order to reduce the risk of HIV infection.
The approval is based on two randomized, double-blinded placebo-controlled trials, Pre-Exposure Prophylaxis Initiative (iPrEx) and Partners PreP. The iPrEx trial enrolled 2,499 HIV-negative individuals who were homosexual couples, and Partners PrEP enrolled 4,558 heterosexual couples. HIV-1 seroconversion was less in patients who received Truvada compared to the placebo group.
Truvada has been approved in the United States to reduce the risk of sexually acquired HIV-1 in adults and adolescents who are at risk of HIV-1 infection. Individuals have to be tested for HIV-1 before initiating the treatment.
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