Gilead’s Biktarvy® Demonstrates Safety and Efficacy in Adults Aged ≥65 with Comorbidities; Now Available in China

July 05, 2020 /BioValleyBIOON/ -- Gilead Sciences recently announced new analysis data on Biktarvy, a novel triple-combination drug for HIV (Chinese brand name: Biktarvy®; generic name: bictegravir/emtricitabine/tenofovir alafenamide tablets; bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg, BIC/FTC/TAF), confirming that:In elderly patients aged ≥65 years who had achieved virologic suppression (n=140), switching to Biktarvy demonstrated favorable efficacy and safety, including in those with common comorbidities, such asDiabetes、Hypertension, cardiovascular disease, dyslipidemia.After switching to Biktarvy, 92% of these patients maintained virologic suppression (HIV RNA <50 copies/mL) at Week 48. These data are from a pooled analysis of four international trials, in which Biktarvy was generally well tolerated. The relevant results will be presented at the 23rd International AIDS Conference (AIDS 2020, virtual).

A pooled analysis of four international trials (Studies 1844, 1878, 4030, and 4449) was conducted to evaluate the efficacy and safety of switching to Biktarvy in treatment-experienced patients aged ≥65 years who had achieved virologic suppression (HIV-1 RNA <50 copies/mL). According to the United StatesFDAsnapshot algorithm, with the primary endpoint being the rate of virologic suppression (HIV-1 RNA <50 copies/mL) at Week 48. In these studies, a total of 140 patients (median age: 68 years) were included in the evaluation; 14% were female and 88% were White.Common comorbidities at baseline include:Diabetes（22%）、Hypertension(55%), cardiovascular disease (24%), dyslipidemia (59%).

Data shows that,At Week 48 of treatment, the proportion of patients with HIV-RNA <50 copies/mL was 92% (129/140)., indicating that Biktarvy maintains a high rate of virologic suppression in the elderly population. In these studies, Biktarvy was generally well tolerated; 11 patients experienced Grade 1 or 2 study drug-related adverse events (AEs), of whom 4 discontinued the study. No Grade 3 or 4 drug-related adverse events or virologic failures occurred. The most commonAdverse ReactionsNasopharyngitis and arthralgia (each accounting for 7%).

As the number of older adults living with HIV continues to grow, optimizing treatment to meet the unique needs of this critical population—including those with chronic conditions who may require polypharmacy—is essential. By 2030, it is projected that up to 70% of people living with HIV will be aged 50 or older, with the majority having at least one other comorbidity. AIDS 2020ConferenceData published above confirm that switching to Biktarvy in adults aged 65 years and older effectively maintains viral suppression, with no significant impact on lipid levels (such as cholesterol), body weight, or interactions with other medications potentially taken for comorbidities.

Biktarvy is a once-daily, single-tablet regimen (STR) for the treatment of HIV-1 infection. This medication combines the potency of the novel integrase strand transfer inhibitor (INSTI) bictegravir (BIC) with the proven efficacy and safety profile of Descovy® (emtricitabine and tenofovir alafenamide tablets, FTC/TAF), a dual-nucleoside reverse transcriptase inhibitor (NRTI) backbone therapy recommended by clinical guidelines for HIV management. Phase III clinical trials demonstrated that Biktarvy achieved very high rates of virologic suppression in both treatment-naïve patients (first-line therapy) and virologically suppressed patients who switched regimens (second-line therapy), with no emergence of treatment-resistant virus.

Biktarvy was approved in the United States in February 2018FDAApproved for marketing, this drug is indicated as a complete regimen for the treatment of HIV-1 infection in children and adults weighing at least 25 kg, including: (1) first-line treatment: for treatment-naïve individuals; (2) second-line treatment: for individuals who have achieved virologic suppression on a stable antiretroviral regimen, have no history of treatment failure, and have no known resistance to any component of Biktarvy, to replace their current antiretroviral regimen.

In China, Biktarvy (Biktarvy®) was approved in Hong Kong in October 2018 and on the Chinese mainland in August 2019. On the mainland, the drug is indicated for use as a complete regimen for the treatment of HIV-1 infection in adults who have no current or historical evidence of viral resistance to integrase inhibitors, emtricitabine, or tenofovir. (Bioon.com)

Original Source:New Findings on Gilead’s Biktarvy® Presented at AIDS 2020: Virtual Include Positive Switch Data in Older Adults