FDA approves Bituve/Bikonprenol tablets for use in HIV patients who have previously received antiretroviral therapy

The U.S. Food and Drug Administration approved bictegravir sodium (bictegravir) 50mg/emtricitabine (emtricitabine) 200mg/tenofovir alafenamide (tenofovir Alafenamide, TAF) 25 mg tablets (B/F/TAF; Biktarvy) are used to treat HIV-infected patients who have previously received antiretroviral therapy and are not virologically suppressed, namely Biktarvy/Biktarvy tablets. The approval also includes patients without known or suspected resistance to integrase chain inhibitors, including emtricitabine or tenofovir.

In the field of AIDS treatment, continued advances in scientific research and person-centered care methods are combined to provide patients with more effective solutions. However, not all patients successfully achieve long-term HIV treatment success, especially if there are interruptions in treatment. In response to this problem, the launch of the new indication allows Bikeren Prenol Tablets to provide support to a wider range of people living with HIV, helping those who have failed to achieve virological suppression, as well as those who are restarting treatment, to move towards their long-term treatment goals.

The new indication is based on evidence from 2 Phase 3 trials: Study 1489 (NCT02607930) and Study 1490 (NCT026077956). In the first study, researchers aimed to determine and evaluate the efficacy of Bicanaprex plus abacavir/dolutegravir/lamivudine in antiretroviral therapy-naïve HIV patients, and the second study examined the efficacy of Bicanax plus dolutegravir in combination with emtricitabine/tenofovir alafenamide in the same patient population.

In these two studies, the primary endpoint is the proportion of individuals with HIV RNA below 50 copies/mL at week 48, while secondary endpoints include the proportion of individuals with HIV RNA below 50 copies/mL at weeks 96 and 144, the proportion of individuals with HIV RNA below 20 copies/mL at each time point, and changes in CD4+ cell counts. Study results showed that up to 98.6% of patients maintained HIV RNA below 50 copies/mL at week 240. In addition, the mean change in CD4+ cell count increased by 338 cells/μL from baseline, and Bikerin did not cause the development of drug resistance.

For those who stop treatment or lose medical follow-up due to various reasonsFor people living with HIV, re-engagement in treatment is critical. This not only prevents the spread of the virus, but also helps support long-term health outcomes for patients. The launch of the new indication allows healthcare providers to more confidently support a wider range of people living with HIV, including those who have not yet achieved virological suppression and are restarting antiviral therapy.

In general, the approval of Bikern Prenol Tablets provides a new treatment option for HIV-infected patients, especially when faced with patients who have failed previous treatments. As research deepens and clinical practice improves, we look forward to more innovative treatment options becoming available in the future to help every HIV-infected person live a healthy life while reducing the risk of virus transmission. By strengthening interaction, education and support between medical teams and patients, we can more effectively respond to this public health challenge and jointly promote progress in HIV treatment.

References:https://www.drugtopics.com/view/fda-approves-biktarvy-for-patients-with-hiv-previously-treated-with-antiretroviral-therapy