Long-acting HIV pre-exposure prophylaxis drugs Catilavir Sodium Tablets and Catilavir Injection formally approved in China

May 15, 2024  Source: drugdu 31

"/On May 13, 2024, GlaxoSmithKline ("GSK") announced that ViiV Healthcare ("ViiV"), its joint venture company specializing in HIV medicines, has received approval from the China State Drug Administration ("SDA") for both cathiravir sodium tablets and cathiravir injection for use in adults and adolescents at risk of infection (weight ≥35kg). ViiV Healthcare ("ViiV"), its joint venture company specializing in HIV, has received approval from the State Drug Administration of China ("SDA") for HIV-1 pre-exposure prophylaxis ("PrEP") in adults and adolescents (≥35kg) at risk for infection to reduce the risk of sexually transmitted infections ("STIs") in conjunction with safer sexual behavioral practices to achieve better HIV-1 PrEP outcomes. It is the first therapy to prevent HIV infection without the need for daily medication, the FDA noted in a December 20, 2021 official press release.
Pre-exposure prophylaxis (PrEP) is an effective biological prophylaxis to prevent HIV infection through the use of antiviral drugs. As an HIV-1 integrase strand transfer inhibitor (INSTI), the long-acting regimen of Catilavir requires only a minimum of six injections per year to achieve HIV pre-exposure prophylaxis. Users will receive a starting injection of 600mg (3ml) per month for the first two months, followed by a continuation injection of 600mg (3ml) every two months. Prior to the first injection, users will have the option of taking oral katiravir sodium tablets for approximately one month (at least 28 days) to assess the tolerability of the drug.
The approval is based on two international Phase IIb/III multicenter, randomized, double-blind, positively controlled studies (HPTN 083 and HPTN 084) designed to evaluate the safety and efficacy of cataplasm sodium long-acting injection for the pre-exposure prophylaxis of HIV in HIV-1 negative men who have sex with men (MSM), transgender females, and cisgender females.The results of the HPTN 083 study demonstrated a significant improvement in the safety and efficacy of cataplasm sodium long-acting injections when compared to the oral daily dose of The results of the HPTN 083 study showed that participants receiving a long-acting injectable solution of cataplasm had a 68% lower risk of HIV infection compared with the daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) regimen (12 vs 39; annual incidence: 0.37% vs 1.22%; HR 0.32 [CI: 0.16, 0.58]).The results of the HPTN 084 study showed a 68% reduction in the risk of HIV infection in participants receiving a long-acting injectable solution of cataplasm, as compared to the TDF/FTC oral tablet group. FTC oral tablet group, the risk of HIV infection was 91% lower in the long-acting injection group (3 vs 36; annual incidence: 0.15% vs 1.85%; HR 0.09 [CI: 0.04, 0.27]).
Ms. Qi Xin, Vice President and General Manager of GSK China, said: "The HIV sector is one of GSK's global business strategic priorities. The approval of a long-acting regimen of cathiravir for HIV pre-exposure prophylaxis provides a new option for people who may benefit from HIV pre-exposure prophylaxis (PWBP), greatly reducing their burden of preventive medication and adding an important tool to end the HIV epidemic. In the future, we will continue to introduce more innovative drugs in the field of HIV to provide long-lasting and innovative treatment options for HIV-infected patients while reducing the risk of HIV infection through effective prevention."
AIDS is one of the major public health problems shared by the world, with about 39 million HIV-infected people in existence. UNAIDS has put forward the goal and commitment to achieve the goal of 95% of the global population at risk of HIV infection receiving effective and comprehensive preventive measures by 2025, so the prevention of new HIV infections has become the key to preventing and controlling the spread of AIDS.
In recent years, China has made every effort to promote the implementation of various HIV prevention and control measures and emphasized the task of HIV prevention and control.
Chinese Center for Disease Control and Prevention of AIDS prevention and control chief expert Han Mengjie researcher pointed out that: " sexual transmission has become China's main transmission of HIV, heterosexual sexual transmission is complex and diverse, men who have sex with men higher risk of sexual transmission. China's HIV prevention and control to curb sexual transmission as the main direction of attack, and actively carry out pre-exposure prophylaxis pilot work. Long-acting pre-exposure prophylaxis drugs will become a new and powerful addition to the comprehensive intervention strategy."
Currently, HIV pre-exposure prophylaxis in China faces many challenges such as disease stigmatization and discrimination, insufficient awareness of populations that may benefit from HIV pre-exposure prophylaxis (PWBP), low willingness to take medication in oral regimens, and poor adherence.
Professor Zhang Fujie, Director of the AIDS Clinical and Research Center of Capital Medical University, said, "Studies have shown that a long-acting regimen of cataprevir significantly reduces the risk of HIV infection in men who have sex with men (MSM), transgender women, and cisgender women, is well-tolerated, and is more effective than a daily oral regimen of emtricitabine/tenofovir disoproxil fumarate (FTC /TDF) and contributes to user adherence. A long-acting regimen of cathiravir is now recommended by the WHO as part of HIV combination prevention.

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