Gilead's Single-Tablet Regimen Biktarvy Demonstrates High Virologic Suppression Rates in HIV Patients with Pre-existing NRTI Resistance
Mar 12, 2019 15:35
CST Updated
15:35
Gilead Sciences
Antiviral Drug Developer
March 11, 2019/BioValleyBIOON/-- U.S. pharmaceutical giant Gilead Sciences recently announced data from two clinical studies of Biktarvy, a new three-in-one combination drug for HIV (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg, BIC/FTC/TAF). These studies were conducted in adult patients with HIV-1 who had achieved virologic suppression, evaluating resistance when switching from the three-in-one combination drug Triumeq (dolutegravir/abacavir/lamivudine, DTG/ABC/3TC) or a boosted protease inhibitor (PI)-based regimen to Biktarvy. The results showed that Biktarvy demonstrated high rates of virologic suppression in treatment-experienced adult patients, regardless of whether they had pre-existing resistance to nucleoside reverse transcriptase inhibitors (NRTIs). These data were recently presented at the 2019 Conference on Retroviruses and Opportunistic Infections (CROI) held in Seattle, USA.Meetingpublished above.
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 therapy recommended by clinical guidelines for HIV treatment. In Phase III clinical studies, the Biktarvy regimen achieved very high rates of virologic suppression in both treatment-naïve adults and adults who were virologically suppressed and switched therapies, with no emergence of treatment-resistant resistance.
In the United States, Biktarvy is indicated as a complete regimen for the treatment of HIV-1 infection in antiretroviral-naïve adults. Biktarvy is also indicated to replace the current antiretroviral regimen in adults who have been virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen for at least three months. Patients who are virologically suppressed must have no history of treatment failure and no known resistance to any component of Biktarvy. The US prescribing information for Biktarvy includes a Boxed Warning regarding the risk of acute exacerbation of hepatitis B following discontinuation of treatment.
In early October 2018, Biktarvy was approved by the Hong Kong Department of Health 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.
Key data summaries presented at the conference included:
Poster 2141: Long-term Efficacy of Biktarvy in Patients with Prior Drug Resistance
For participants who achieved the primary endpoint at Week 48 in two Phase 3 switching studies of Biktarvy (Study 1844 and Study 1878)Subjects were followed for 2 years during the open-label extension phase. Analyses demonstrated high rates of virologic suppression among adult patients who switched from Triumeq or a boosted protease inhibitor (PI)-based regimen to Biktarvy, both in the overall study population (n=561/570, 98%) and in the subgroup with pre-existing resistance (n=155/159, 97%), including those with pre-existing M184V/I mutations (n=42/44, 95%). No treatment-emergent resistance was observed in any patient during the study.
Poster 3362:Biktarvy inHigh Virologic Suppression Rates in Patients with Pre-existing High-Level NRTI Resistance Prior to Switching
This ongoing randomized, double-blind Phase III study (Study 4030) evaluated the switch to DTG+F/TAF or Biktarvy over 48 weeks in 565 virologically suppressed adult patients previously treated with DTG+F/TAF or DTG+F/TDF. Patients with any documented resistance to nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), or protease inhibitors (PIs) were eligible for enrollment, whereas those with documented integrase strand transfer inhibitor (INSTI) resistance were excluded. Results showed that 14% (n=78/565) of patients had known or suspected NRTI resistance at screening. When historical data and additional baseline proviral HIV-1 DNA genotyping were included, this proportion increased to 24% (n=138/565). In this pooled, blinded interim analysis, 99% (n=557/562) of subjects maintained undetectable viral loads (HIV RNA <50 copies/mL) without emergent resistance during post-baseline follow-up. Furthermore, 99% (n=220/222) of subjects with resistance to any class of antiretroviral (ARV) drugs, including those with M184V/I mutations (n=79/81, 98%), also maintained undetectable viral loads and exhibited no treatment-emergent resistance.
John McHutchison, Chief Scientific Officer and Head of Research and Development at Gilead Sciences, stated, “The fact that virologic suppression was maintained when switching to Biktarvy, even in the presence of resistance to certain classes of antiretroviral drugs, demonstrates the versatility of Biktarvy. These data add to the growing body of evidence supporting Biktarvy as a single-tablet regimen for use across a broad range of clinical settings.”(Bio Valley Bioon.com)