ViiV Healthcare Announces Positive Data Demonstrating 2-drug Regimen Dovato Is as Effective as 3-drug Regimen Biktarvy for Maintenance Therapy of HIV-1
ViiV Healthcare Announces Positive Data Demonstrating 2-drug Regimen Dovato Is as Effective as 3-drug Regimen Biktarvy for Maintenance Therapy of HIV-1
- Largest head-to-head randomised clinical trial between DTG/3TC and BIC/FTC/TAF, conducted by SEIMC-GeSIDA Foundation (FSG) showed DTG/3TC demonstrated non-inferior efficacy compared to BIC/FTC/TAF as a switch regimen for virologically-suppressed adults living with HIV over 48 weeks of therapy
- DTG/3TC-treated individuals had significantly less weight gain compared to those randomised to BIC/FTC/TAF
- SEIMC-Gesida基金會(FSG)在DTG/3TC和BIC/FTC/TAF之間進行的最大規模的頭對頭隨機臨床試驗顯示,與BIC/FTC/TAF相比,在48周的治療中,作爲病毒學抑制的成年艾滋病毒感染者的切換方案,DTG/3TC的療效並不遜色
- 與隨機分配給 BIC/FTC/TAF 的患者相比,接受了 DTG/3TC 治療的患者的體重增加明顯降低
GSK plc (LSE/NYSE: GSK) announced that ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, has shared 48-week findings from the PASO DOBLE (GeSIDA 11720 study), the largest head-to-head, phase IV randomised clinical trial (RCT) investigating the 2-drug regimen Dovato (dolutegravir/lamivudine [DTG/[3TC]) compared to the 3-drug regimen Biktarvy (bictegravir/emtricitabine]/tenofovir alafenamide fumarate [BIC/FTC/TAF]) for the treatment of HIV-1 in people who are virologically suppressed and who could benefit from treatment optimisation.
葛蘭素史克集團(倫敦證券交易所/紐約證券交易所代碼:GSK)宣佈,葛蘭素史克控股的全球艾滋病毒專業公司ViiV Healthcare已分享了PASO DOBLE(gesIda 11720研究)爲期48周的調查結果,該研究是調查雙藥方案Dovato(dolutegravir/lams)的最大規模的IV期隨機臨床試驗(RCT)。與三種藥物方案 Biktarvy(bictegravir/恩曲他濱)/替諾福韋阿拉芬酰胺富馬酸替諾福韋 [BIC/FTC/TAF])對比,用於治療病毒學抑制且可能受病毒抑制的人群的 HIV-1受益於治療優化。
Findings showed that switching to DTG/3TC in virologically suppressed adults living with HIV demonstrated non-inferior efficacy in maintaining viral suppression compared with switching to BIC/FTC/TAF.1 These data will be presented at the 25th International AIDS Conference (AIDS 2024), held in Munich, Germany (22-26 July).
研究結果表明,與改用BIC/FTC/TAF相比,在受病毒學抑制的成年艾滋病毒感染者中改用DTG/3TC在維持病毒抑制方面的效果並不遜色。1 這些數據將在德國慕尼黑舉行的第25屆國際艾滋病會議(AIDS 2024)(7月22日至26日)上公佈。
Harmony P. Garges, M.D., MPH, Chief Medical Officer at ViiV Healthcare, said: "The results from PASO DOBLE show that Dovato demonstrated non-inferior efficacy compared to Biktarvy, and that the average weight gain for trial participants taking DTG/3TC was significantly lower than those taking BIC/FTC/FTC over the course of the year. This is a meaningful outcome, as treatment-related weight gain is an important topic for many people living with HIV. At ViiV Healthcare we're dedicated to bringing innovative HIV treatments to people living with HIV that are not only safe and effective, but also address their specific needs beyond viral suppression."
ViiV Healthcare首席醫學官Harmony P. Gargeswand.D.,MPH表示:“PASO DOBLE的結果表明,與Biktarvy相比,多瓦託的療效並不遜色,而且在過去的一年中,服用DTG/3TC的試驗參與者的平均體重增加明顯低於服用BIC/FTC/FTC的受試者的平均體重增加。這是一個有意義的結果,因爲與治療相關的體重增加是許多HIV感染者的重要話題。在ViiV Healthcare,我們致力於爲HIV感染者提供創新的HIV治療方法,這些治療不僅安全有效,而且還能滿足他們除病毒抑制以外的特定需求。”
In the PASO DOBLE clinical trial, 553 people living with HIV and virally suppressed switched treatment to either DTG/3TC (n=277) or BIC/FTC/TAF (n=276). The study population included individuals who were on therapy that could be optimised, such as multiple tablet regimens, or those containing pharmacokinetic boosting agents or drugs with cumulative toxicity, such as efavirenz or tenofovir disoproxil fumarate (TDF). The study met its primary endpoint when DTG/3TC demonstrated non-inferior efficacy versus BIC/FTC/TAF based on the proportion of participants with viral RNA ≥50 copies/mL at 48 weeks using the FDA snapshot and a 4% non-inferiority margin in the exposed intention-to-treat population.
在PASO DOBLE臨床試驗中,553名艾滋病毒攜帶者和病毒抑制者轉向了DTG/3TC(n=277)或BIC/FTC/TAF(n=276)的治療。研究人群包括正在接受可以優化的治療的人,例如多種片劑方案,或者那些含有藥代動力學增強劑或具有累積毒性的藥物,例如依法韋侖或富馬酸替諾福韋二泊西爾(TDF)的人。當DTG/3TC與BIC/FTC/TAF相比,根據FDA快照在48周時病毒RNA≥50拷貝/mL的參與者的比例以及暴露的意向治療人群中非劣勢度爲4%,DTG/3TC顯示出不低於BIC/FTC/TAF的療效時,該研究達到了主要終點。
At 48 weeks, DTG/3TC was non-inferior to BIC/FTC/TAF (risk difference between DTG/3TC [2.2%] minus BIC/FTC/TAF [0.7%] of 1.4%, 95% CI -0.5 to 3.4). One participant in the BIC/FTC/TAF arm and zero in the DTG/3TC arm had protocol-defined confirmed virological failure through week 48 (HIV-1 RNA ≥50 c/mL followed by a second consecutive HIV-1 RNA assessment ≥200 c/mL).
在48周時,DTG/3TC不遜於BIC/FTC/TAF(DTG/3TC之間的風險差 [2.2%] 減去BIC/FTC/TAF [0.7%] 爲1.4%,95%置信區間爲-0.5至3.4)。截至第48周,BIC/FTC/TAF組的一名參與者和DTG/3TC組的零名參與者已根據協議定義確認的病毒學失敗(HIV-1 RNA ≥50 c/mL,隨後連續第二次進行了 HIV-1 RNA 評估≥200 c/mL)。
The study found in a key secondary endpoint that weight increased significantly more in participants who switched to BIC/FTC/TAF (adjusted mean change 1.81kg, 95% CI 1.28-2.34) than in those who switched to DTG/3TC (adjusted mean change 0.89kg, 95% CI 0.37-1.41) [difference 0.92kg, 95% CI 0.17-1.66] through week 48. Equally, the proportion of participants with weight gain greater than 5% at week 48 was significantly higher at 29.9% for BIC/FTC/TAF compared to 20% for DTG/3TC (adjusted OR 1.81, 95% CI 1.19-2.76).
該研究在一個關鍵的次要終點發現,在第48周改用BIC/FTC/TAF(調整後的平均變化1.81kg,95%置信區間1.28-2.34)(調整後的平均變化0.89kg,95%置信區間0.17-1.66)[差異爲0.92kg,95%置信區間0.17-1.66] 的參與者體重的增加幅度明顯更多。同樣,BIC/FTC/TAF在第48周體重增加超過5%的參與者比例明顯更高,爲29.9%,而DTG/3TC的參與者比例爲20%(調整後的OR 1.81,95%置信區間1.19-2.76)。
Weight change with DTG/3TC did not differ between men and women or based on the previous regimen of participants, whereas the proportion of trial participants experiencing greater than 5% weight gain with BIC/FTC/TAF was approximately 45% higher than those taking DTG/3TC when switching from a regimen with abacavir (30.6% BIC/FTC/TAF vs 21.1% DTG/3TC), and about 2-fold higher when switching from a regimen with TDF (40.7% BIC/FTC/TAF vs 19.5% DTG/3TC). Safety was comparable through week 48 and consistent with known safety profiles. There were few discontinuations due to adverse events in both study arms (DTG/3TC = 1, 0.4%; BIC/FTC/TAF = 2, 0.7%), with no differences between arms.1
在男性和女性之間,或基於參與者先前的方案,DTG/3TC的體重變化沒有差異,而在從阿巴卡韋方案切換時,使用BIC/FTC/TAF體重增加超過5%的試驗參與者的比例比服用DTG/3TC的受試者高出約45%(BIC/FTC/TAF對21.1% DTG/3TC),從阿巴卡韋方案切換時高出約2倍其中 TDF(40.7% BIC/FTC/TAF 對比 19.5% DTG/3TC)。截至第48周,安全性相當,與已知的安全狀況一致。兩個研究組幾乎沒有因不良事件而停藥的情況(DTG/3TC = 1,0.4%;BIC/FTC/TAF = 2,0.7%),兩組之間沒有差異。1
Esteban Martínez, MD, PhD, Chief Executive Investigator of the PASO DOBLE study and Senior Consultant in Infectious Diseases at Hospital Clínic of Barcelona, Spain said: "The HIV treatment regimens that are commonly prescribed today are all highly effective, which makes it critical that we study the impact of these therapies beyond just viral suppression. The results from PASO DOBLE show Dovato, a 2-drug regimen, not just demonstrated the same efficacy as a 3-drug regimen, but also showed less weight gain compared to BIC/FTC/TAF through 48 weeks."
埃斯特班·馬丁內斯醫學博士、PASO DOBLE研究的首席執行研究員、西班牙巴塞羅那醫院診所傳染病高級顧問說:“當今常見的HIV治療方案都非常有效,因此我們必須研究這些療法的影響,而不僅僅是病毒抑制。PASO DOBLE的結果顯示,與BIC/FTC/TAF相比,Dovato是一種雙藥方案,不僅表現出與三種藥物相同的療效,而且在48周內體重增加的幅度也較小。”
About PASO DOBLE
關於 PASO DOBLE
The PASO DOBLE (NCT04884139) randomised clinical trial is a phase IV, open-label, randomised multicentre clinical trial evaluating the efficacy of DTG/3TC versus BIC/FTC/TAF for the maintenance of virologic suppression in people living with HIV-1, conducted in 30 sites across Spain. Virologically suppressed people living with HIV on regimens containing ≥1 pill/day, boosters, or drugs with cumulative toxicity such as efavirenz or TDF were eligible and were randomised (1:1) to switch to either DTG/3TC or BIC/FTC/TAF. The primary endpoint was the proportion of people living with HIV with RNA ≥50 copies/mL at 48 weeks (FDA snapshot, 4% non-inferiority margin) in the intention-to-treat exposed population. Secondary outcomes measured included, among others, absolute weight gain, BMI change, and the proportion of participants with weight change greater than 5%.
PASO DOBLE(NCT04884139)隨機臨床試驗是一項IV期、開放標籤、隨機的多中心臨床試驗,評估了DTG/3TC與BIC/FTC/TAF在維持HIV-1 患者病毒學抑制方面的療效,該試驗在西班牙的30個地點進行。服用含有≥1粒/天、加強劑或具有累積毒性的藥物(例如依法韋侖或TDF)的治療方案中病毒學抑制的HIV感染者符合資格,並被隨機分配(1:1),改用DTG/3TC或BIC/FTC/TAF。主要終點是意向治療暴露人群中,48周時RNA≥50拷貝/mL的HIV感染者的比例(FDA快照,非劣勢率爲4%)。測得的次要結果包括絕對體重增加、體重指數變化以及體重變化大於5%的參與者比例等。
About Dovato
關於多瓦託
Dovato is indicated as a complete regimen to treat HIV-1 infection in adults with no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable ARV regimen with no history of treatment failure and no known resistance to any component of Dovato.
對於沒有抗逆轉錄病毒(ARV)治療史的成年人來說,Dovato 是一種完整的治療方案,或者使用穩定的抗逆轉錄病毒療法(HIV-1 RNA
Dovato is approved in the US, Europe, Japan, Australia, and other countries worldwide.
Dovato 已在美國、歐洲、日本、澳大利亞和全球其他國家獲得批准。
Please consult the full Summary of Product Characteristics for all the safety information: Dovato 50 mg/300 mg film-coated tablets.
有關所有安全信息,請參閱完整產品特性摘要:Dovato 50 mg/300 mg 薄膜包衣片劑。
Trademarks are owned by or licensed to the ViiV Healthcare group of companies.
商標歸ViiV Healthcare集團公司所有或授權給他們。
About SEIMC-GeSIDA Foundation (FSG)
關於 SEIMC-Gesida 基金會 (FSG)
The SEIMC-GeSIDA Foundation (FSG) was created to encourage, promote, and support scientific and technical research and development, training, and publication of findings in the field of clinical microbiology and infectious diseases and associated conditions.
SEIMC-Gesida基金會(FSG)旨在鼓勵、促進和支持臨床微生物學、傳染病及相關疾病領域的科學和技術研發、培訓和研究結果的出版。
FSG was founded by investigators from the Spanish Society of Clinical Microbiology and Infectious Diseases as a tool to promote high-quality investigation in the field of HIV infection and other infectious diseases. The Foundation also aims to respond to the scientific concerns of the group's members. FSG is composed of qualified professionals with experience in the field of clinical trials and multicentre studies. Its streamlined infrastructure facilitates performance of clinical studies and responds to the needs of investigators in terms of methodology/statistical analysis and of logistics and management of trials and other multicentre studies.
FSG由西班牙臨床微生物學和傳染病學會的研究人員創立,旨在促進HIV感染和其他傳染病領域的高質量研究。該基金會還旨在回應該組織成員的科學問題。FSG 由具有臨床試驗和多中心研究領域經驗的合格專業人員組成。其簡化的基礎設施促進了臨床研究的進行,並滿足了研究人員在方法/統計分析以及試驗和其他多中心研究的後勤和管理方面的需求。
We also provide staff to run events such as scientific meetings and conferences (national and international) and to organise courses, lectures, talks, seminars, round-table talks, and specialised workshops.
我們還安排員工舉辦科學會議和會議(國內和國際)等活動,並組織課程、講座、講座、研討會、圓桌講座和專業研討會。
For more information on the FSG, please visit
有關 FSG 的更多信息,請訪問
About ViiV Healthcare
關於 ViiV 醫療保健
ViiV Healthcare is a global specialist HIV company established in November 2009 by GSK (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of acquiring HIV. Shionogi became a ViiV shareholder in October 2012. The company's aims are to take a deeper and broader interest in HIV and AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV. For more information on the company, its management, portfolio, pipeline, and commitment, please visit viivhealthcare.com.
ViiV Healthcare是一家全球艾滋病專業公司,由葛蘭素史克(倫敦證券交易所代碼:GSK)和輝瑞(紐約證券交易所代碼:PFE)於2009年11月成立,致力於爲艾滋病毒感染者和有感染艾滋病毒風險的人提供先進的治療和護理。Shionogi 於 2012 年 10 月成爲 ViiV 的股東。該公司的目標是比以往任何公司都更深入、更廣泛地關注艾滋病毒和艾滋病,並採取新的方法來提供有效的創新艾滋病毒治療和預防藥物,併爲受艾滋病毒影響的社區提供支持。有關該公司及其管理、投資組合、渠道和承諾的更多信息,請訪問viivhealthcare.com。
About GSK
關於 GsK
GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.
葛蘭素史克是一家全球生物製藥公司,其宗旨是聯合科學、技術和人才,共同戰勝疾病。要了解更多信息,請訪問 gsk.com。
Cautionary statement regarding forward-looking statements
關於前瞻性陳述的警示聲明
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D "Risk factors" in GSK's Annual Report on Form 20-F for 2023, and GSK's Q1 Results for 2024.
葛蘭素史克提醒投資者,葛蘭素史克做出的任何前瞻性陳述或預測,包括本公告中的前瞻性陳述或預測,都存在風險和不確定性,可能導致實際業績與預期存在重大差異。這些因素包括但不限於葛蘭素史克2023年20-F表年度報告第3.D項 “風險因素” 下描述的因素,以及葛蘭素史克2024年第一季度業績。
References
參考文獻
- P. Ryan, et al. Non-inferior efficacy and less weight gain when switching to DTG/3TC than when switching to BIC/FTC/TAF in virologically suppressed people with HIV (PWH): the PASODOBLE (GeSIDA 11720) randomised clinical trial. Presented at the 25th International AIDS Conference. July 2024
- P. Ryan 等人與轉用BIC/FTC/TAF相比,對病毒學抑制的HIV感染者(PWH),改用DTG/3TC時的療效不遜色,體重增加也更少:PASODOBLE(gesIDA 11720)隨機臨床試驗。在第25屆國際艾滋病會議上發表。2024 年 7 月