Big5 hospitals adds Glead’s new HIV option Biktarvy

Since NHI reimbursement listing in July Big5 DCs passed the treatment

Drops booster to prevent drug interaction

Glead’s new HIV combination drug, Biktarvy is landing its code on tertiary hospital’s prescription list.

 

According to pharmaceutical industry source, Biktarvy has been passed by drug committee (DC) at the Big Five tertiary hospitals in Korea, including Seoul National University Hospital, Samsung Seoul Medical Center, Severance Hospital and others, after the drug passed the insurance listing in July.

 

The main active agent of Biktarvy, bictegravir has been evaluated as a powerful second generation integrase inhibitor that displays a high resistance barrier lowering the risk of developing resistance.

 

Tenofovir alafenamide is also a nucleoside reverse transcriptase inhibitor (NRTI) backbone that shows improved safety profile of tenofovir disoproxil fumarate (TDF).

 

Biktarvy does not require HLA-B*5701 genetic screening and it is able to start treatment fast as it does not have restriction on patients’ viral load or CD4 count.

 

The treatment regimen is an orally taken once-daily tablet, and a patient can take the tablet regardless of food intake.

 

Biktarvy has high barrier to resistance, and it enhanced patient’s administration convenience presenting the smallest size of tablet among three-drug combination drug on HIV infection.

 

Gilead confirmed Biktarvy’s safety and efficacy in four of Phase 3 clinical studies --Study 1489, Study 1490, Study 1844, and Study 1878-- on adult patients with HIV infection who had or not had antiretroviral treatment,.

 

Professor Kim Yeon-Sook of virology department at Chungnam University Hospital explained, “The median age of HIV-infected patients who received antiretroviral treatment has reached 48.

 

HIV infection accelerates development of renal, cardiovascular system, hepatic, bone, neurological and cancer diseases, as the therapy puts pressure on certain aging process.” “While the overall population’s number of death by cardiovascular disease has been going down, the number of death by cardiovascular disease in patients with HIV infection has gone up from seven percent to 13 percent.

 

To reduce the risk of cardiovascular disease in HIV-infected patient, blood pressure and lipid managements are needed,” the professor added.

 

In Study 1844 that compared 563 adult patients with HIV-1, who have undergone antiretroviral therapy for at least three months, the participants in respective arms were treated with ABC, DTG, 3TC and Biktarvy.

 

The result found only 1 percent of 282 patients who switched to Biktarvy had virological failure at 48 weeks.

 

The treatment arm demonstrated noninferior efficacy compared to ABC, DTG and 3TC arms (n=281), as the 94 percent of Biktarvy arm maintained virologic suppression.

 

In both Study 1844 and Study 1878 of 48-week Phase 3 clinical trials, Biktarvy demonstrated no case of emergent drug resistance.