Gilead Unveils New Yearly HIV Injection To Offer Hope for Less Frequent Preventive Dosing
Gilead Unveils New Yearly HIV Injection To Offer Hope for Less Frequent Preventive Dosing
In September, At the HIV Analyst & Investor Event on Tuesday, Gilead Sciences Inc. (NASDAQ:GILD) revealed that it is developing a once-yearly injectable formulation for lenacapavir.
在週二的HIV分析師和投資者活動上，吉利德科技公司（納斯達克：GILD）透露正在開發一種每年注射一次的lenacapavir製劑。
The annual formulation is currently in Phase 1 study, with data to be presented.
該年度製劑目前正在進行一期研究，將有數據公佈。
In its investor presentation, the company said it expects the pivotal Phase 3 pharmacokinetics study's first patient to be in 2025, and potential regulatory filings will begin in late 2027.
在其投資者演示中，該公司表示預計關鍵的三期藥代動力學研究的首名患者將在2025年入組，潛在的監管申請將在2027年末開始。
In September, Gilead revealed the results of an interim analysis from a second Phase 3 trial investigating the use of the company's twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir.
在九月份，吉利德公佈了第二個三期試驗的中期分析結果，該試驗調查了公司的每年兩次注射HIV-1衣殼抑制劑lenacapavir的使用。
Lenacapavir reduced HIV infections by 96% compared to background HIV incidence.
與背景HIV發生率相比，lenacapavir降低了96%的HIV感染。
Also Read: HIV Drugmaker Gilead Reports Strongest Quarterly Performance Of 2024, Analysts Boost Price Target On Raised Outlook
另請閱讀：HIV藥企吉利德報告2024年最強季度業績，分析師提升目標價以應對上調展望。
In November, the New England Journal of Medicine published the full results from Gilead's Phase 3 PURPOSE 2 trial evaluating twice-yearly lenacapavir for HIV prevention.
在十一月，《新英格蘭醫學雜誌》發佈了吉利德三期PURPOSE 2試驗關於每年兩次lenacapavir用於HIV預防的完整結果。
The study found that twice-yearly lenacapavir for pre-exposure prophylaxis (PrEP) was highly efficacious at reducing HIV infections, reducing them by 96% compared to background HIV incidence.
該研究發現，每年兩次注射lenacapavir用於暴露前預防（PrEP）在降低HIV感染方面的效果極爲顯著，相較背景HIV發生率降低了96%。
Twice-yearly lenacapavir for PrEP also demonstrated superiority to once-daily Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg; F/TDF) for PrEP and was generally well-tolerated, with no significant or new safety concerns identified.
每六個月一次的lenacapavir作爲預防用藥（PrEP）顯示出優於每日一次的Truvada（恩曲他濱200毫克和替諾福韋二唑烷二磷酸鹽300毫克；F/TDF）的效果，並且通常耐受性良好，沒有發現明顯或新的安全性問題。
In 2021, the FDA approved ViiV Healthcare's Apretude, the first injectable form of PrEP administered every two months.
在2021年，FDA批准了ViiV Healthcare的Apretude，這是一種每兩個月注射一次的預防用藥（PrEP）的第一種注射形式。
Pfizer Inc (NYSE:PFE) and GSK Plc (NYSE:GSK) own ViiV Healthcare.
輝瑞公司（紐交所：PFE）和葛蘭素史克公司（紐交所：GSK）擁有ViiV Healthcare。
STAT News highlights that Gilead plans to seek approval for a PrEP injection that requires only two clinic visits per year. This less frequent dosing has been shown to be more effective than traditional daily oral PrEP.
STAt 資訊強調，吉利德計劃申請一種預防用藥（PrEP）注射劑的批准，該注射劑每年僅需兩次門診。與傳統的每日口服預防用藥相比，這種較少的給藥頻率已被證明更有效。
However, global access to these new PrEP options remains a challenge. Former CDC director Rochelle Walensky criticized ViiV for not prioritizing accessibility in Africa and urged Gilead to ensure broader availability of its drug lenacapavir.
然而，全球獲取這些新預防用藥（PrEP）選項仍然是一個挑戰。前CDC董事Rochelle Walensky批評ViiV未將可及性作爲優先事項，並敦促吉利德確保其藥物lenacapavir的更廣泛可用性。
Unlike vaccines, which train the immune system to recognize and fight viruses long-term, PrEP relies on antivirals that are effective only while active in the body. The main challenge has been developing drugs that remain effective for extended periods.
與生物-疫苗不同，生物-疫苗訓練免疫系統長期識別和對抗病毒，預防用藥（PrEP）依賴於有效期僅在體內活躍期間的抗病毒藥物。主要挑戰是開發能在較長時間內保持有效的藥物。
While significant progress has been made with long-lasting PrEP, the same cannot be said for HIV vaccines.
儘管在持久的預防用藥（PrEP）方面取得了顯著進展，但對HIV生物-疫苗而言情況並非如此。
Efforts to create a vaccine have struggled against the virus's complexity, and no vaccines are currently in late-stage trials following recent setbacks.
創造生物-疫苗的努力在病毒複雜性面前受挫，目前沒有生物-疫苗在近期挫折後進入晚期試驗。
The success of long-term PrEP may further complicate vaccine development by reducing the urgency for alternatives.
長期預防性用藥的成功可能會通過減少對替代方法的緊迫感，進一步複雜化生物-疫苗的開發。
Price Action: GILD stock is up 0.73% at $93.05 at the last check on Thursday.
價格走勢：GILD股票在週四最後一次檢查時上漲了0.73%，報價93.05美元。
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