November 29, 2021

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FDA approved Gilead’s low-dose Biktarvy for HIV-1 children infected!

FDA approved Gilead's low-dose Biktarvy for HIV-1 children infected!

FDA approved Gilead’s low-dose Biktarvy (Biktarvy®) for use in young (weight 14-25 kg) HIV-1 children infected!



 

FDA approved Gilead’s low-dose Biktarvy for HIV-1 children infected!

HIV pediatric new drug! The US FDA approved Gilead’s low-dose Biktarvy (Biktarvy®) for use in young (weight 14-25 kg) HIV-1 children infected!

Biktarvy is a new three-in-one compound drug, which was launched in Hong Kong and China in October 2018 and August 2019.

 

Gilead Sciences recently announced that the U.S. Food and Drug Administration ( FDA ) has approved the new three-in-one compound drug Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) Cetiravir/emtricitabine/propofol tenofovir, BIC/FTC/TAF, 30mg/120mg/15mg, low-dose tablets), used for body weight at least 14 kg to 25 kg, has achieved virology Suppress, or have just started antiretroviral drug (ARV) treatment for HIV-1 children infected .

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 adults and children.

 

Although effective treatment options available to pregnant women infected with HIV reduce the possibility of transmission of HIV infection during the perinatal period, pediatric HIV remains a global health problem.

In 2020, about 850 children worldwide will be infected with HIV every day, and about 330 children will die from HIV-related causes, mainly due to inadequate access to HIV care and treatment services.

Providing monolithic antiretroviral therapy for children weighing at least 14 kg is an important milestone with the potential to save many lives.

 

The FDA approved Biktarvy for HIV-1 infection in children weighing at least 14 kg, based on data from cohort 3 of the Phase 2/3 open-label single-arm study (NCT02881320).

The results showed that among children infected with HIV-1 who have achieved virological suppression, Biktarvy low-dose tablets are effective and generally tolerated for 24 weeks.

Cohort 3 enrolled 22 HIV-1 children infected with HIV-1 weighing at least 14 kg to 25 kg. These patients continued treatment for 48 weeks, and then continued to receive study drugs through an extended period.

After switching to Biktarvy, 91% (20/22) of patients maintained virological suppression at week 24, and the average change in CD4% from baseline was 0.2%.

Due to the discontinuation of research related to the COVID-19 pandemic, 2 patients did not collect HIV-1 RNA at week 24. In pediatric studies, compared with adults, no new adverse reactions or laboratory abnormalities were found.

 

Dr. Merdad Parsey, Chief Medical Officer of Gilead, said: “Children infected with HIV need effective and easily available antiretroviral therapy formulations.

To meet this unmet need, innovation in pediatric formulations must strive to expand treatment options for children.

The approval of the sNDA is an important step towards achieving Gilead’s goal of bringing Biktarvy pediatric formula to children living with HIV around the world.”

 

FDA approved Gilead's low-dose Biktarvy for HIV-1 children infected!

 

Biktarvy is a single-tablet regimen (STR) taken orally once a day for the treatment of HIV-1 infection.

The drug combines the efficacy of the new 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), the latter It is a dual-acting nucleoside reverse transcriptase inhibitor (NRTI) backbone therapy recommended by HIV clinical treatment guidelines.

In the phase 3 clinical study, Biktarvy achieved a very high virological inhibition rate when used to treat patients who had not previously received treatment (initial treatment) and patients who achieved virological suppression and switched treatment options (treated). There was no resistance to treatment.

 

In the United States, Biktarvy was approved for marketing in February 2018. The current indications of the drug are: as a complete regimen, it is used to treat HIV-1 infected pediatric patients (weight ≥ 14 kg) and adult patients .

These patients have no A history of treatment failure, and there are no known mutations associated with resistance to each component of Biktarvy.

Specifically:

(1) patients with no history of antiretroviral therapy; (

2) patients who have received stable antiretroviral regimens and have achieved virological suppression, replacing their current antiretroviral regimens.

It should be pointed out that Biktarvy’s drug label is accompanied by a black box warning, indicating the risk of acute exacerbation of hepatitis B after treatment.

 

 

 

 

FDA approved Gilead’s low-dose Biktarvy for HIV-1 children infected!

(source:internet, reference only)


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