FDA Approves Biktarvy for Drug-Resistant Infections in HIV Treatment

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FDA Approves Biktarvy for Drug-Resistant Infections in HIV Treatment

On February 27, 2024, the FDA (Food and Drug Administration) approved the expanded use of Biktarvy for the treatment of HIV-infected individuals with undetectable viral loads but carrying multiple drug-resistant genes, particularly for those with the Nucleoside Reverse Transcriptase Inhibitor (NRTI) typical resistance mutation M184V/I.

This updated indication was authorized based on data submitted from Study 4030. Currently, the Department of Health and Human Services (DHHS) HIV treatment guidelines also recommend the use of Biktarvy for M184V/I-resistant treatment.

This news marks a positive development in the field of HIV treatment, offering new hope for HIV patients with limited treatment options due to multiple drug-resistant mutations.

FDA Approves Biktarvy for Drug-Resistant Infections in HIV Treatment

M184V/I is one of the most common resistances among HIV-infected individuals, accounting for 22-63% of resistance to NRTIs, which is permanent and irreversible.

Biktarvy’s combination includes a novel integrase strand transfer inhibitor, Bictegravir (50mg), which blocks HIV integration into human cell DNA, a critical step for virus replication and cell infection. It also contains two reverse transcriptase inhibitors, Emtricitabine (200mg) and Tenofovir Alafenamide (25mg), which inhibit the replication process of HIV. It is the first and only single-tablet regimen based on an integrase strand transfer inhibitor, and currently the most widely used HIV antiviral drug globally (accounting for approximately 36.3% worldwide). This three-in-one combination tablet provides a complete regimen in one pill, offering a new treatment option for doctors and patients to simplify treatment, especially for those in need of simplified treatment regimens.

Biktarvy was approved in China in August 2019 for the treatment of HIV-1 infection in adults who have no known resistance to integrase strand transfer inhibitor drugs, emtricitabine, or tenofovir alafenamide. Specifically, it is indicated for patients without prior antiretroviral therapy history, or for those who have achieved virological suppression with a stable antiretroviral regimen to replace their current antiretroviral regimen. In Phase 3 clinical studies, it demonstrated very high virological suppression rates when used to treat treatment-naive (first-line) patients and patients who achieved virological suppression and switched treatment regimens (experienced patients), with no cases of resistance failure.

Note: Biktarvy’s drug label carries a boxed warning regarding the risk of acute exacerbation of hepatitis B after treatment.

As an innovative drug, Biktarvy is not only used for initial treatment but has now also received approval for resistant treatment, further demonstrating its outstanding potential and value in the field of HIV treatment. It may be used in combination with other drugs in the future to form more effective treatment regimens, and its application prospects are promising. However, like all drugs, Biktarvy should be used under the guidance of a doctor to ensure treatment safety. Regular monitoring of HIV viral load and CD4 cell counts is also necessary.