New HIV Drugs! Biktarvy ® real-world data: Safe & effective in people with HIV with various comorbidities!

October 25, 2022 /BioValleyBIOON/ --Gilead Sciences recently announced the three-in-one compound drug Biktarvy (Chinese trade name: Bitovir, generic name: Biktigravir tablets, bictegravir ® 50mg/emtricitabine 200mg/tenofovir propofovir 25mg, BIC/FTC/ TAF) Real World Data (RWD) from the BICSTaR study: Confirm that Biktarvy is a universally well-tolerated and effective treatment regimen, regardless of prior treatment or comorbidity status in HIV-infected patients
.
In addition, the latest 5-year data from two phase 3 studies (Study 1489, Study 1490) provide evidence
of Biktarvy's long-term safety and efficacy in HIV-infected people who switch from dolutegravir-based regimens to Biktarvy treatment.

A follow-up analysis of the BICSTaR study from 24 months provided 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 considered the age, ethnicity, gender, adherence, and late diagnosis
of the population.
Patients initiating Biktarvy achieved a high degree of virologic suppression (HIV-1 RNA<50 copies/mL).
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Overall, 97% (104/107) of treatment-naïve patients and 95% (497/521) of treated patients achieved virological suppression (deletion = exclusion analysis)
at 24 months of treatment with Biktarvy.
No treatment-induced resistance was reported
.
Discontinuation rates (14% overall) were low, and few patients (7%) discontinued due to drug-related adverse events (DRAEs
).
The most common drug-related adverse events were weight change (3%) and depression (1%)
.
These data strengthen Biktarvy's safety and durability
for people with high comorbidities living with HIV.

Dr.
Benoit Trottier, Director of Research and Physician at the Urbaine du Quartier Latin Clinic in Montreal, Canada, commented: "These latest data show how innovation and improvement in HIV treatment options can help people living with HIV and their clinicians identify an HIV treatment regimen that supports their long-term treatment
.
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 the 1489 study and the 1490 study, presented at the meeting, indicate that Biktarvy has high efficacy and sustained safety for patients undergoing switching therapy, as well as persistently high drug resistance
.
These results were from patients
who switched to open-label Biktarvy for 96 weeks after 144 weeks of blinded dolutegravir + 2 NRTI regimens.

At week 240, virologic suppression
was achieved in more than 99% of patients in study 1489 (217/218; deletion = exclusion) and 1490 study (232/234; deletion = excluded).
In addition, studies have shown that in each visit over 240 weeks, the effectiveness > 96% after switching to Biktarvy treatment (missing = excluded), suggesting that Biktarv can provide sustained virological suppression for HIV patients, even
after switching to therapy.

Biktarvy was well tolerated overall, with 0.
4% (2/519) of patients switching regimens in two studies experiencing adverse effects
leading to discontinuation of the drug during the open-label extension period.
Treatment of renal causes has not been interrupted
.
During the open-label expansion period, the most common adverse events were diarrhoea (0.
6%) and weight change (0.
6%)
.

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

Jared Baeten, vice president of HIV clinical development at Gilead Science, said: "As we strive to drive scientific innovation to help end the AIDS epidemic, we are committed to a treatment research program that meets the individual needs
of all people living with HIV.
Gilead's ongoing human-centered research focuses on the changing needs and preferences
of people living with HIV.
These latest data from this conference demonstrate the clinical use of innovative drugs such as Biktarvy to help a wide range of people living with HIV, regardless of their comorbid burden
.
”

Biktarvy is a once-daily oral single tablet regimen (STR) used to treat HIV-1 infection
.
The drug combines the efficacy of a novel integrase chain 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-acting nucleoside reverse transcriptase inhibitor (NRTI) backbone therapy
recommended by HIV clinical treatment guidelines 。 In the Phase 3 clinical study, Biktarvy achieved very high rates of virological inhibition in both previously untreated (treatment-naïve) patients and patients who achieved virological suppression and switched treatment regimens (treatment), and no treatment resistance occurred
.

In the United States, Biktarvy (BIC/FTC/TAF, 50 mg/200 mg/25 mg) was approved in February 2018 for the treatment of HIV-1-infected pediatric patients (body 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 without a history of antiretroviral therapy; (2) Patients who have achieved virological suppression after receiving a stable antiretroviral regimen 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 exacerbations of
hepatitis B after treatment.

In October 2021, the U.
S.
FDA approved Biktarvy (BIC/FTC/TAF, 30mg/120mg/15mg, low-dose tablets) for children with HIV-1 who weigh at least 14 kg to 25 kg, have achieved virological suppression, or are just starting antiretroviral drug (ARV) therapy
.
Providing monolithic antiretroviral therapy to children weighing at least 14 kg is an important milestone
with the potential to save many lives.
This approval expands Biktarvy's indications to include young children infected with HIV-1, which will help reduce the gap
in access to HIV treatment options between adult and child populations.

In China, Biktarvy ® was approved in Hong Kong in October 2018 and mainland China in
August 2019.
Pittovir is indicated in China as a complete regimen for adults with human immunodeficiency virus type 1 (HIV-1) infection and patients with no current and prior evidence
of viral resistance to integrase inhibitors, emtricitabine, or tenofovir ®.
(Bio Valley Bioon.
com)

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