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.
在星期二的HIV分析師與投資者活動上，吉利德科學公司（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第一階段研究，並將提供數據。
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.
在其投資者介紹中，該公司表示預計關鍵的第三階段藥物動力學研究的第一位患者將於2025年入組，潛在的監管申請將於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第三階段試驗的中期分析結果，該試驗研究了該公司每年注射兩次的HIV-1外殼抑制劑lenacapavir的使用。
Lenacapavir reduced HIV infections by 96% compared to background HIV incidence.
與背景HIV發病率相比，lenacapavir將HIV感染減少了96%。
Also Read: HIV Drugmaker Gilead Reports Strongest Quarterly Performance Of 2024, Analysts Boost Price Target On Raised Outlook
另請閱讀：HIV藥物製造商吉利德報告2024年季度業績最強，分析師提高了對該公司前景的價格目標。
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.
在十一月份，《新英格蘭醫學雜誌》發表了吉利德第三階段PURPOSE 2試驗的完整結果，該試驗評估了每年注射兩次的lenacapavir在HIV預防中的作用。
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.
研究發現，每年注射兩次的lenacapavir用於暴露前預防（PrEP）在減少HIV感染方面非常有效，將感染率減少了96%，與背景HIV發病率相比。
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.
每年兩次使用lenacapavir進行預防也顯示出優於每天一次服用的Truvada（恩曲他濱200毫克和替諾福韋二吡呋酯300毫克；F/TDF）進行預防，且通常耐受性良好，沒有發現顯著或新的安全性問題。
In 2021, the FDA approved ViiV Healthcare's Apretude, the first injectable form of PrEP administered every two months.
2021年，FDA批准了ViiV Healthcare的Apretude，這是首個每兩個月注射一次的預防藥物。
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 News強調，吉利德計劃尋求批准一種預防注射，只需每年進行兩次門診。這種較少的給藥頻率已被證明比傳統的每日口服預防更有效。
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，全球對這些新預防選項的獲取仍然是一項挑戰。前CDC董事Rochelle Walensky批評ViiV未優先考慮在非洲的可及性，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.
與訓練免疫系統長期識別和抵抗病毒的生物-疫苗不同，預防依賴於只有在體內有效時才有效的抗病毒藥物。主要挑戰是開發能夠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.
儘管在長效預防方面取得了重大進展，但對於HIV生物-疫苗的情況則不能相同。
Efforts to create a vaccine have struggled against the virus's complexity, and no vaccines are currently in late-stage trials following recent setbacks.
創造疫苗的努力在對抗病毒的複雜性方面遇到了困難，目前尚無疫苗處於晚期試驗階段，近期的挫折使情況更加嚴峻。
The success of long-term PrEP may further complicate vaccine development by reducing the urgency for alternatives.
長期預防措施的成功可能會通過降低替代品的緊迫性而進一步 complicate 生物-疫苗的開發。
Price Action: GILD stock is up 0.73% at $93.05 at the last check on Thursday.
價格動態：GILD 股票在週四最後一次確認時上漲了 0.73%，價格爲 $93.05。
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譯文內容由第三人軟體翻譯。