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 announced positive 48-week results from the PASO DOBLE study, comparing the 2-drug regimen Dovato (dolutegravir/lamivudine) to the 3-drug regimen Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide fumarate) for HIV-1 treatment. The study showed that:
1. Dovato demonstrated non-inferior efficacy in maintaining viral suppression compared to Biktarvy.
2. Participants taking Dovato experienced significantly less weight gain compared to those on Biktarvy.
3. Safety profiles were comparable between both regimens.
These findings support Dovato as an effective treatment option for virologically-suppressed adults living with HIV, addressing concerns about treatment-related weight gain.
ViiV Healthcare ha annunciato risultati positivi a 48 settimane dello studio PASO DOBLE, confrontando il regime a 2 farmaci Dovato (dolutegravir/lamivudina) con il regime a 3 farmaci Biktarvy (bictegravir/emtricitabina/tenofovir alafenamide fumarato) per il trattamento dell'HIV-1. Lo studio ha mostrato che:
1. Dovato ha dimostrato una efficacia non inferiore nel mantenimento della soppressione virale rispetto a Biktarvy.
2. I partecipanti che assumevano Dovato hanno avuto un guadagno di peso significativamente inferiore rispetto a quelli con Biktarvy.
3. I profili di sicurezza erano comparabili tra i due regimi.
Questi risultati supportano Dovato come un'opzione di trattamento efficace per adulti virologicamente soppressi che vivono con HIV, affrontando le preoccupazioni relative al guadagno di peso associato al trattamento.
ViiV Healthcare anunció resultados positivos a 48 semanas del estudio PASO DOBLE, comparando el régimen de 2 medicamentos Dovato (dolutegravir/lamivudina) con el régimen de 3 medicamentos Biktarvy (bictegravir/emtricitabina/tenofovir alafenamida fumarato) para el tratamiento de HIV-1. El estudio mostró que:
1. Dovato demostró una eficacia no inferior en mantener la supresión viral en comparación con Biktarvy.
2. Los participantes que tomaron Dovato experimentaron un significativamente menor aumento de peso que aquellos en Biktarvy.
3. Los perfiles de seguridad fueron comparables entre ambos regímenes.
Estos hallazgos apoyan a Dovato como una opción de tratamiento efectiva para adultos virológicamente suprimidos que viven con VIH, abordando preocupaciones sobre el aumento de peso relacionado con el tratamiento.
ViiV Healthcare는 HIV-1 치료를 위한 2가지 약물 요법Dovato(돌루테그라비르/라미부딘)과 3가지 약물 요법Biktarvy(비크테그라비르/엠트리시타빈/테노포비르 알라페나미드 퓨마르산염)를 비교한 PASO DOBLE 연구의 48주 긍정적 결과를 발표했습니다. 연구에서는 다음과 같은 결과가 나타났습니다:
1. Dovato는 Biktarvy에 비해 비열등한 효능을 보여주었습니다.
2. Dovato를 복용한 참가자들은 Biktarvy를 복용한 참가자들에 비해 상당히 적은 체중 증가를 경험했습니다.
3. 두 요법의 안전성 프로필은 유사했습니다.
이러한 결과는 HIV 감염으로 바이러스 억제가 이루어진 성인들을 위한 효과적인 치료 옵션으로서 Dovato의 위치를 지지하며, 치료 관련 체중 증가에 대한 우려를 다루고 있습니다.
ViiV Healthcare a annoncé des résultats positifs sur 48 semaines de l'étude PASO DOBLE, comparant le régime à 2 médicaments Dovato (dolutégravir/lamivudine) au régime à 3 médicaments Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide fumarate) pour le traitement du VIH-1. L'étude a montré que :
1. Dovato a démontré une efficacité non inférieure pour maintenir la suppression virale par rapport à Biktarvy.
2. Les participants prenant Dovato ont connu une augmentation de poids significativement inférieure par rapport à ceux prenant Biktarvy.
3. Les profils de sécurité étaient comparables entre les deux régimes.
Ces résultats soutiennent Dovato en tant qu'option de traitement efficace pour les adultes virologiquement supprimés vivant avec le VIH, en abordant les préoccupations concernant la prise de poids liée au traitement.
ViiV Healthcare gab positive 48-Wochen-Ergebnisse der PASO DOBLE-Studie bekannt, die das 2-Arzneimittel-Regime Dovato (Dolutegravir/Lamivudin) mit dem 3-Arzneimittel-Regime Biktarvy (Bictegravir/Emtricitabin/Tenofovir-Alafenamid-Fumarat) zur HIV-1-Behandlung vergleicht. Die Studie zeigte, dass:
1. Dovato eine nicht minderwertige Wirksamkeit bei der Aufrechterhaltung der viralen Suppression im Vergleich zu Biktarvy aufwies.
2. Teilnehmende, die Dovato einnahmen, erlebten signifikant weniger Gewichtszunahme im Vergleich zu denen, die Biktarvy einnahmen.
3. Die Sicherheitsprofile waren zwischen beiden Regimen vergleichbar.
Diese Ergebnisse unterstützen Dovato als effektive Behandlungsoption für virologisch unterdrückte Erwachsene mit HIV und gehen auf Bedenken hinsichtlich der gewichtsbedingten Nebenwirkungen der Behandlung ein.
- Dovato demonstrated non-inferior efficacy compared to Biktarvy in maintaining viral suppression
- Participants taking Dovato experienced significantly less weight gain (0.89kg) compared to Biktarvy (1.81kg)
- Lower proportion of participants on Dovato (20%) experienced >5% weight gain compared to Biktarvy (29.9%)
- Few discontinuations due to adverse events in both study arms (Dovato: 0.4%, Biktarvy: 0.7%)
- None.
The PASO DOBLE study results are a significant leap in the field of HIV treatment. This phase IV randomized clinical trial has shown that the 2-drug regimen Dovato is non-inferior in efficacy compared to the 3-drug regimen Biktarvy for maintaining viral suppression. The standout finding here is the reduced weight gain associated with Dovato, which addresses a key patient concern. Maintaining weight stability is critical for long-term health outcomes in HIV patients. This could potentially shift treatment paradigms, especially for patients concerned about weight gain related to their therapy.
From a financial perspective, this news is quite impactful for ViiV Healthcare. The positive outcome of the PASO DOBLE study could lead to increased adoption of Dovato over Biktarvy, which may translate into higher market share and revenue growth for ViiV. Investors will likely view this as a positive development, especially given the competitive landscape of HIV treatments. Moreover, the fact that this study was the largest head-to-head comparison adds to its credibility and could drive significant market interest.
The market implications of the PASO DOBLE study are noteworthy. The reduced weight gain associated with Dovato compared to Biktarvy could make it a preferred choice among healthcare providers and patients. This might lead to a competitive edge for ViiV Healthcare in the HIV treatment market. Additionally, the findings presented at a major international conference like AIDS 2024 will further bolster the visibility and acceptance of Dovato. This news could potentially disrupt the current market dynamics in favor of ViiV Healthcare.
- 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
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
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.”
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).1 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).2 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
At 48 weeks, DTG/3TC was non-inferior to BIC/FTC/TAF (risk difference between DTG/3TC [
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,
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
Esteban Martínez, MD, PhD, Chief Executive Investigator of the PASO DOBLE study and Senior Consultant in Infectious Diseases at Hospital Clínic of
About PASO DOBLE1,2
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
About Dovato
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.
Dovato is approved in the US,
Please consult the full Summary of Product Characteristics for all the safety information: Dovato 50 mg/300 mg film-coated tablets.
Trademarks are owned by or licensed to the ViiV Healthcare group of companies.
About SEIMC-GeSIDA Foundation (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. 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. 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.
For more information on the FSG, please visit https://fundacionseimcgesida.org/en/quienes-somos/
About ViiV Healthcare
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.
About 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.
Cautionary statement regarding forward-looking statements
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.
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References
1 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
2 Clinical Trials.gov - DTG/3TC vs. BIC/FTC/TAF Maintenance Therapy in People Living With HIV: (PASO-DOBLE). Available at https://clinicaltrials.gov/ct2/show/NCT04884139. Last accessed July 2024
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FAQ
What were the main findings of the PASO DOBLE study comparing Dovato and Biktarvy for HIV-1 treatment?
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