ADC Reviews

New HIV drug Biktarvy released real-world data, significant safety and efficacy


Gilead Sciences recently announced the real-world data (RWD) of the three-in-one compound new drug Biktarvy BICSTaR study at the 30th International Conference on Drug Therapy for HIV Infection (HIV Glasgow 2022) in 2022: confirming that Biktarvy is a common A well-tolerated and effective treatment regimen, regardless of prior treatment or comorbidity status in HIV-infected individuals. In addition, the most recent 5-year data from 2 Phase 3 studies (Study 1489, Study 1490) provide evidence of long-term safety and efficacy of Biktarvy in HIV-infected individuals who switched from dolutegravir-based regimens to Biktarvy therapy .

A follow-up analysis from the 24-month BICSTaR study provides new real-world data. The study evaluated the efficacy and safety of Biktarvy in clinical practice in nine countries. The analysis included follow-up during the COVID-19 pandemic and took into account the population’s age, ethnicity, gender, adherence, and late diagnosis. Patients who initiated Biktarvy treatment achieved a high degree of virological suppression (HIV-1 RNA <50 copies/mL).

Overall, 97% (104/107) of treatment-naïve patients and 95% (497/521) of treatment-experienced patients achieved virological suppression at 24 months of Biktarvy treatment (absence = exclusion analysis). Treatment-induced resistance was not reported. Discontinuation rates (14% overall) were low, with few patients (7%) discontinuing due to drug-related adverse events (DRAEs). The most common drug-related adverse events were weight change (3%) and depression (1%). These data reinforce the safety and robustness of Biktarvy in HIV-infected individuals with high comorbidity.

Benoit Trottier, MD, Director of Research and Physician at the Urbaine du Quartier Latin Clinic in Montreal, Canada, commented: “These latest data demonstrate how innovations and improvements in HIV treatment options can help people living with HIV and their clinicians identify an HIV treatment option that supports their long-term care. Factors such as aging and comorbidities are an important part of long-term health discussions. The BICSTaR study reinforces the true effectiveness of Biktarvy in a range of comorbid populations, and the findings are consistent with evidence from randomized clinical trials of Biktarv treatment.”

Additional data from Study 1489 and Study 1490 presented at the meeting demonstrated that Biktarvy had a high efficacy and sustained safety profile in patients who switched therapy, with continued high drug resistance. These results are from patients who received 144 weeks of blinded dolutegravir plus 2 NRTI regimens and then switched to open-label Biktarvy for 96 weeks.

At Week 240, more than 99% of patients in Study 1489 (217/218; deletion=excluded) and Study 1490 (232/234; deletion=excluded) achieved virologic suppression. In addition, the study demonstrated >96% efficacy after switching to Biktarvy therapy at each visit over 240 weeks (missing = excluded), suggesting that Biktarv may provide HIV patients with sustained virological suppression, even after switching The same is true after treatment.

Biktarvy was generally well tolerated, with 0.4% (2/519) of patients who switched regimens experienced adverse reactions leading to discontinuation of the drug during the open-label extension period in both studies. No treatment interruptions for renal reasons occurred. During the open-label extension period, the most common adverse events were diarrhea (0.6%) and weight change (0.6%).

On October 14, 2022, the U.S. Food and Drug Administration (FDA) approved a labeling change for Biktarvy, updating the prescribing information to include 144-week efficacy data and 240-week safety data for adults with HIV who initiated treatment in Study 1489 and Study 1490 Sexual data.

Jared Baeten, vice president of HIV clinical development at Gilead Sciences, said: “As we work to advance scientific innovation to help end the AIDS epidemic, we are committed to a therapeutic research program that meets the individual needs of all people living with HIV. Gilead is working on Conducted human-centred research focused on the changing needs and preferences of people living with HIV. These latest data, presented at this meeting, demonstrate that the clinical application of innovative medicines such as Biktarvy can help a broad range of people living with HIV, regardless of their What is the comorbidity burden?”

Biktarvy is a once-daily oral single tablet regimen (STR) for the treatment of HIV-1 infection. The drug combines the potency of the novel integrase strand transfer inhibitor (INSTI) bictegravir (BIC) with the proven efficacy and safety of the marketed drug Descovy (emtricitabine 200 mg/tenofovir alafenamide 25 mg, FTC/TAF), which It is a dual-acting nucleoside reverse transcriptase inhibitor (NRTI) backbone therapy recommended by HIV clinical treatment guidelines. In Phase 3 clinical studies, Biktarvy achieved very high rates of virological suppression in both treatment-naïve (treatment-naive) patients and in patients who achieved virological suppression and switched to treatment (treatment-experienced), and No treatment-emergent resistance occurred.

In the United States, Biktarvy (BIC/FTC/TAF, 50mg/200mg/25mg) was approved for marketing in February 2018. The current indication of the drug is: as a complete regimen for the treatment of pediatric patients with HIV-1 infection (weight ≥25 kg) and adult patients with no history of treatment failure and no known mutations associated with resistance to each component of Biktarvy. Specifically: (1) patients with no history of antiretroviral therapy; (2) patients who have achieved virological suppression on a stable antiretroviral regimen to replace their current antiretroviral regimen. It should be noted that Biktarvy’s drug label is accompanied by a boxed warning about the risk of acute exacerbation of hepatitis B after treatment.

In October 2021, the U.S. FDA approved Biktarvy (BIC/FTC/TAF, 30mg/120mg/15mg, low-dose tablet) for use in patients with a body weight of at least 14 kg to less than 25 kg, who have achieved virological suppression, or have just started receiving antiretroviral therapy HIV-1-infected children treated with ARVs. The introduction of single-tablet antiretroviral therapy to children weighing at least 14 kg is an important milestone with the potential to save many lives. The approval expands Biktarvy’s indication to include young children living with HIV-1, which will help reduce the gap in access to HIV treatment options between adults and children.

In China, Biktarvy was approved in Hong Kong in October 2018 and in mainland China in August 2019. Bituvi® is indicated in China as a complete regimen for the treatment of adults with human immunodeficiency virus type 1 (HIV-1) infection who are currently and have not been treated with integrase inhibitors, emtricitabine or tenofovir Evidence of viral resistance.

Original source: Gilead Presents Real-World Evidence Reinforcing the Use of Biktarvy® for the Treatment of People Living With HIV With a Range of Comorbidities