Gilead's Once-Daily Single-Tablet Regimen Biktarvy Demonstrates Long-Term Efficacy and Safety in Women Living with HIV, Approved in Hong Kong

July 24, 2019/BioValleyBIOON/--U.S. pharmaceutical giant Gilead Sciences recently held the 2019 International AIDS Society Conference on HIV Science in Mexico CityMeeting(IAS 2019) published the long-term (96-week) results of a Phase III clinical study evaluating the triple-combination novel HIV drug Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg, BIC/FTC/TAF) in women living with HIV.

This is an international, multicenter, randomized, open-label Phase III study that enrolled 470 female patients who achieved virologic suppression with their baseline regimen. The baseline regimens included: Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [150/150/200/10 mg]), elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (150/150/200/300 mg), or atazanavir plus ritonavir plus emtricitabine/tenofovir disoproxil fumarate (300+100+200/300 mg). In the study, these patients were randomized in a 1:1 ratio to either switch from their baseline regimen to Biktarvy or continue their baseline regimen.

This study was conducted exclusively in female participants. The primary endpoint results have been previously published; at Week 48 of treatment, the data confirmed non-inferiority in maintaining virologic suppression, with a low incidence of serious adverse events and no emergence of drug resistance. All patients, including those on their baseline regimens, switched to Biktarvy therapy at Week 48 and continued through Week 96.

At Week 96, 99.5% of female patients who received Biktarvy throughout the study and 98.5% of female patients who switched to Biktarvy at Week 48 maintained virologic suppression (missing = excluded; M=E), with no treatment-emergent resistance observed. Biktarvy also demonstrated good tolerability, with a low frequency of serious adverse events.

Dr. Cissy Kityo, Executive Director of the Joint Clinical Research Centre in Uganda and principal investigator of the study, stated, “Despite the fact that women account for the majority of new HIV infections globally, they are underrepresented in HIV”Clinical Trialsare largely underrepresented. The results of this study, which specifically focuses on female patients with HIV infection, provide important long-term data on the safety, tolerability, and efficacy of Biktarvy in this significant patient population.”

Biktarvy 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), a dual-nucleoside reverse transcriptase inhibitor (NRTI) backbone regimen recommended by clinical HIV treatment guidelines. In Phase III clinical studies, the Biktarvy regimen achieved very high rates of virologic suppression in both treatment-naïve adults and virologically suppressed adults who switched therapy, with no emergence of treatment-resistant virus.

In the United States, Biktarvy is indicated as a complete regimen for the treatment of HIV-1 infection in adults or pediatric patients (weighing ≥25 kg) who are antiretroviral treatment-naïve. Biktarvy is also indicated to replace the current antiretroviral regimen in adults or pediatric patients (weighing ≥25 kg) with HIV-1 infection who are virologically suppressed on a stable antiretroviral regimen, provided they have no history of treatment failure and no known resistance to any component of Biktarvy. On June 28, 2019, the United StatesFDAApproval of Biktarvy Labeling Revision to Expand the Patient Population to Include Pediatric Patients Weighing ≥25 kg. It should be noted that the U.S. product labeling for Biktarvy includes a Boxed Warning regarding the risk of acute exacerbation of hepatitis B following treatment discontinuation.

In China, Biktarvy was approved by the Hong Kong Department of Health in early October 2018 as a once-daily, single-tablet regimen (STR) for the treatment of HIV-1 infection in adults. This approval also made Hong Kong, China, the first market in Asia where Biktarvy was authorized for launch. In late March this year, Biktarvy also received approval in Japan.

In 2018, the United StatesFDAA total of 62 new drugs were approved. The foreign pharmaceutical industry website PharmaCompass compiled data from multiple sources to estimate the peak sales for these new drugs. The results showed that among the 62 drugs, Biktarvy topped the list with a projected peak sales figure as high as $5.269 billion. (Bioon.com)

Original Source:Gilead Sciences Website