ViiV Healthcare to announce data from largest head-to-head randomised clinical trial for 2-drug regimen Dovato against 3-drug regimen Biktarvy at AIDS 2024
ViiV Healthcare, majority owned by GSK, will present 25 abstracts at the 25th International AIDS Conference in Munich, including the largest head-to-head randomized clinical trial comparing their 2-drug regimen Dovato against the 3-drug regimen Biktarvy. Key presentations include:
1. PASO-DOBLE study: 48-week findings on treatment efficacy, safety, and weight changes for Dovato vs Biktarvy
2. Pregnancy data for Apretude (cabotegravir long-acting injectable) for PrEP
3. Phase I findings of VH184, a third-generation integrase inhibitor with potential for ultra long-acting applications
4. Real-world evidence for long-acting treatment regimen Cabenuva
These presentations underscore ViiV Healthcare's leadership in developing long-acting and 2-drug regimens for HIV treatment and prevention, addressing patient needs beyond viral suppression.
- Presentation of 25 abstracts at AIDS 2024, showcasing a broad range of HIV treatment and prevention options
- Largest head-to-head randomized clinical trial comparing 2-drug Dovato against 3-drug Biktarvy
- Introduction of VH184, a third-generation integrase inhibitor with potential for ultra long-acting applications
- Real-world evidence supporting the effectiveness of long-acting treatment regimen Cabenuva
- None.
ViiV Healthcare's head-to-head clinical trial comparing the two-drug regimen Dovato against the three-drug regimen Biktarvy represents a significant advancement in HIV treatment research. The PASO-DOBLE study aims to provide comprehensive data on treatment efficacy and safety over a 48-week period. This kind of trial can substantiate the non-inferiority claims of Dovato compared to the standard three-drug regimen, which has implications for both patient quality of life and healthcare provider decisions.
By focusing on weight gain and other safety metrics, this study addresses common concerns about long-term treatment side effects. Weight gain is particularly relevant as antiretroviral therapy can often lead to metabolic changes. If Dovato shows fewer side effects without compromising efficacy, it may become a preferred option for many patients.
Another key aspect is the presentation of findings from the DYAD and SOUND studies, which assess long-term outcomes and efficacy among virologically suppressed individuals. These studies are important as they provide data about switching treatments, which is a common scenario in clinical practice.
For retail investors, the potential for reduced medication burden and fewer side effects could increase the uptake of Dovato, potentially enhancing ViiV Healthcare's market position. However, investors should also be aware that the effectiveness of these findings hinges on peer review and broader acceptance in the medical community.
From a market perspective, ViiV Healthcare's announcement has several promising aspects. The head-to-head comparison of Dovato and Biktarvy, two leading antiretroviral treatments, could influence prescribing patterns and market share substantially. If Dovato proves to be non-inferior while offering fewer side effects, particularly with regard to weight gain, it may appeal to a wider patient population and potentially increase market penetration for ViiV.
The introduction of a third-generation integrase inhibitor and data on long-acting injectable therapies like Cabenuva align with the industry's shift toward more patient-friendly treatment options. Long-acting injectables, for example, address issues of adherence commonly associated with daily oral regimens. This could be particularly appealing in markets where adherence is a significant barrier to treatment efficacy.
Real-world evidence and pipeline data further bolster ViiV's position as an innovator in HIV treatment. However, investors should consider the competitive landscape, as other pharmaceutical companies are also advancing their HIV treatment portfolios. ViiV’s ability to maintain and grow its market share will depend on how these new data are received by healthcare providers and patients.
In the short term, the outcomes of these studies could drive stock performance positively if the results are favorable. Long-term, investors should watch for approval processes and adoption rates in clinical practice.
- Findings from the SEIMC-GeSIDA Foundation (FSG) PASO-DOBLE study will include treatment efficacy, safety, and weight gain experienced by participants taking Dovato (dolutegravir/lamivudine) or Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide)
- Additional key abstracts from ViiV Healthcare’s industry-leading, long-acting pipeline and portfolio include data introducing a third-generation integrase strand transfer inhibitor (INSTI) with potential for ultra long-acting applications; pregnancy data for Apretude (cabotegravir long-acting injectable) for PrEP; and real-world evidence for long-acting treatment regimen Cabenuva (cabotegravir + rilpivirine long-acting)
Harmony P. Garges, M.D., Chief Medical Officer at ViiV Healthcare, said: “The exciting findings we’ll be presenting at AIDS 2024 continue to underscore our position as industry leaders in the development of long-acting and 2-drug regimens and our pioneering approaches to both HIV treatment and prevention. People living with HIV continue to tell us they want more treatment options to allow for more personal choice to address needs beyond viral suppression. The breadth of the data we’re announcing, including the head-to-head study between Dovato and Biktarvy, helps individuals better understand those options. We’re proud to be at the forefront of innovative science, driving advancements that have and will continue to transform the future of HIV care and contribute to ending the epidemic.”
Key abstracts to be presented at AIDS 2024 by ViiV Healthcare and its study partners will include:
Head-to-head study comparing ViiV Healthcare’s oral 2-drug regimen against a commonly prescribed oral 3-drug regimen: The FSG-sponsored PASO-DOBLE head-to-head RCT of the 2-drug regimen Dovato (DTG/3TC) compared with the 3-drug regimen Biktarvy (BIC/FTC/TAF) will be presented as a late breaker abstract. The non-inferiority study assessed virologically suppressed adults on an established treatment regimen and who could benefit from treatment optimisation, who were randomised to switch to treatment with DTG/3TC or BIC/FTC/TAF. Researchers will share 48-week findings on treatment efficacy and safety, as well as changes in weight experienced by participants while taking either regimen.1
Additional findings for DTG/3TC will include the DYAD study, presenting 48-week findings among virologically suppressed participants with no prior virologic failure who either switched to DTG/3TC or remained on BIC/FTC/TAF;2 and 96-week findings from the SOUND study, which followed virologically suppressed participants with unknown resistance history who switched from BIC/FTC/TAF to DTG/3TC.3
Pregnancy data from the HPTN 084 open label extension study for Apretude: New findings will be presented from the HPTN 084 trial that assess the impact of cabotegravir long-acting (LA) for PrEP exposure during pregnancy.4,5 The study focuses on maternal, pregnancy, and infant safety outcomes among participants who became pregnant during the open label extension of HPTN 084 and continued with injections of cabotegravir LA for PrEP.
New pipeline data from ViiV Healthcare’s third generation INSTI: Researchers will share phase I findings from the first-time-in-human study of VH184, a third-generation integrase inhibitor (INSTI), along with analysis showing potent activity in vitro against multiple INSTI resistant mutations.6 This is the first data presentation of the company’s next INSTI as a part of its ultra long-acting development strategy.
Real-world evidence from long-acting treatment regimen: Findings from several real-world studies of the complete long-acting HIV treatment regimen cabotegravir + rilpivirine long-acting (CAB+RPV LA) will be presented, including the perspectives of people living with HIV 12 months after switching their treatment regimen to CAB+RPV LA from the BEYOND study;7,8 effectiveness, participant adherence to injections, and patient reported outcomes from the German cohort of the CARLOS study;9 and utilisation and effectiveness of CAB+RPV LA among virologically suppressed, treatment-experienced individuals from the COMBINE-2 study.10
Here is a list of ViiV Healthcare-sponsored or supported studies to be presented at AIDS 2024:
Title |
First author |
Presentation number |
Presentation |
Dolutegravir/3TC |
|||
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) randomized clinical trial |
P. Ryan |
OAB3606LB |
Oral
Date of presentation: Friday, 26 July
Session time: 12:00-13:00 CEST
|
PAIRED - Patient reported experiences and perceived benefit of treatment with dolutegravir/lamivudine - qualitative interviews: diverse group of people with HIV-1 (PWH) reflect on life and health |
J. Slim |
THPEB094 |
Poster
Date of presentation: Thursday, 25 July
Time of presentation: 12:00-13:00 CEST
|
Real-world effectiveness and tolerability of the 2-drug regimen dolutegravir and lamivudine (DTG/3TC) in people living with HIV: a systematic literature review and meta-analysis from clinical practice |
J. Fraysse |
TUPEB101 |
Poster
Date of presentation: Tuesday, 23 July
Time of presentation: 12:00-13:00 CEST
|
Effectiveness and durability of dolutegravir/lamivudine in older people with HIV from the Veterans Aging Cohort Study (VACS) |
L. Yan |
WEPEB111 |
Poster
Date of presentation: Wednesday, 24 July
Time of presentation: 12:00-13:00 CEST
|
Switch to dolutegravir/lamivudine (DTG/3TC) in people living with HIV-1 suppressed on bictegravir/emtricitabine/ tenofovir alafenamide (B/F/TAF): 96-week final analysis from the SOUND study |
J. Slim
|
THPEB092 |
Poster
Date of presentation: Thursday, 25 July
Time of presentation: 12:00-13:00 CEST
|
Efficacy, safety and tolerability of switching to dolutegravir/lamivudine in virologically suppressed adults living with HIV on bictegravir/emtricitabine/tenofovir alafenamide - 48-week results from the DYAD study |
C. Rolle |
THPEB089 |
Poster
Date of presentation: Thursday, 25 July
Time of presentation: 12:00-13:00 CEST
|
Dolutegravir |
|||
Viral suppression, viral failure and safety outcomes in children and adolescents on dolutegravir (DTG) in |
K. Scott
|
OAB3803 |
Oral
Session date: Friday, 26 July
Session time: 13:30-14:30 CEST
|
Changes in body mass index in children and adolescents in |
S. Crichton
|
TUPEB086 |
Poster
Date of presentation: Tuesday, 23 July
Time of presentation: 12:00-13:00 CEST
|
Prenatal dolutegravir-based regimen use, and pregnancy and birth outcomes: data from the Antiretroviral Pregnancy Registry |
V. Vannappagari |
TUPEB128 |
Poster
Date of presentation: Tuesday, 23 July
Time of presentation: 12:00-13:00 CEST
|
Effectiveness and durability of dolutegravir/ rilpivirine in older people with HIV from the Veterans Aging Cohort Study (VACS)
|
L. Yan |
THPEB090 |
Poster
Date of presentation: Thursday, 25 July
Time of presentation: 12:00-13:00 CEST
|
Cabotegravir for treatment |
|||
Subcutaneous injections of cabotegravir + rilpivirine in virally suppressed adults with HIV-1: a substudy of the phase 3 FLAIR study |
R. D’Amico |
OAB2604 |
Oral
Session date: Thursday, 25 July 2024
Session time: 15:00-16:00 CEST
|
Clinical outcomes at month 12 after initiation of cabotegravir and rilpivirine long acting (CAB+RPV LA) in an observational real-world study (BEYOND) |
S. Schneider
|
THPEB099 |
Poster
Date of presentation: Thursday, 25 July
Time of presentation: 12:00-13:00 CEST
|
Perspectives of people with HIV (PWH) 12 months following a switch to cabotegravir and rilpivirine long-acting (CAB+RPV LA) in an observational real-world US study (BEYOND) |
W. Valenti |
TUPEB116 |
Poster
Date of presentation: Tuesday, 23 July
Time of presentation: 12:00-13:00 CEST
|
12-Month outcomes of cabotegravir plus rilpivirine long-acting every 2 months in a real-world setting: effectiveness, adherence to injections, and patient-reported outcomes from people with HIV-1 in the German CARLOS cohort |
C. Jonsson-Oldenbüttel |
TBUPEB095 |
Poster
Date of presentation: Tuesday, 23 July
Time of presentation: 12:00-13:00 CEST
|
Increased screening for sexually transmitted infections and HIV surrogate marker testing among long-acting injectable versus daily oral antiretroviral therapy users in the OPERA® cohort |
P. C. Lackey
|
WEPEC319 |
Poster
Date of presentation: Wednesday, 24 July
Time of presentation: 12:00-13:00 CEST
|
Real-world utilization and effectiveness of long-acting cabotegravir + rilpivirine in virologically suppressed treatment experienced individuals in |
A. Pozniak |
TUPEC278 |
Poster
Date of presentation: Tuesday, 23 July
Time of presentation: 12:00-13:00 CEST
|
Re-thinking ‘community’ in the implementation of long-acting injectable cabotegravir and rilpivirine: qualitative findings from the ILANA study |
R. Hayes |
TUPEE529 |
Poster
Date of presentation: Tuesday, 23 July
Time of presentation: 12:00-13:00 CEST
|
Adherence through the prism of long-acting injectable therapy: qualitative findings from the ILANA implementation study |
S. Paparini |
TUPED306 |
Poster
Date of presentation: Tuesday, 23 July
Time of presentation: 12:00-13:00 CEST
|
“Closer to a cure:” mixed-methods analysis of reasons for switching to cabotegravir + rilpivirine |
S. Paparini |
WEPEE551 |
Poster
Date of presentation: Wednesday, 24 July
Time of presentation: 12:00-13:00 CEST
|
Cabotegravir for PrEP |
|||
“The simplest way to go:” A mixed methods analysis of why women who inject drugs selected long-acting injectable cabotegravir instead of daily oral PrEP |
A. M. Roth |
OAD07 |
Oral
Session date: Tuesday, 23 July
Session time: 17:05-17:13 CEST
|
Knowledge, awareness, feasibility, and acceptability of long-acting cabotegravir for HIV prevention: results from the SEARCH Dynamic Choice HIV prevention trial |
E. Kakande |
OAE12 |
Oral
Session date: Wednesday, 24 July
Session time: 10:41-10:49 CEST
|
Location preferences for accessing long-acting injectable pre-exposure prophylaxis (LA-PrEP) among men who have sex with men (MSM) in the US currently using daily-oral PrEP |
J. L. Glick
|
WEPEC269 |
Poster
Date of presentation: Wednesday, 24 July
Time of presentation: 12:00-13:00 CEST
|
HIV pre-exposure prophylaxis awareness, willingness, and use among transfeminine persons with high likelihood of HIV in |
D. I. Yaras |
THPEC186 |
Poster
Date of presentation: Thursday, 25 July
Time of presentation: 12:00-13:00 CEST
|
Preference for long-acting HIV prevention methods among transgender women at greatest risk for HIV acquisition in eastern and southern |
E. E. Cooney |
THPED410 |
Poster
Date of presentation: Thursday, 25 July
Time of presentation: 12:00-13:00 CEST
|
Influencers and decision-making factors for choosing injectable PrEP among men who have sex with men and transgender men in |
D. Dandachi |
THPEE504 |
Poster
Date of presentation: Thursday, 25 July
Time of presentation: 12:00-13:00 CEST
|
Need for increased HIV testing prior to and during pre-exposure prophylaxis with cabotegravir long-acting injections in routine clinical care in |
R. K. Hsu |
WEPEB046 |
Poster
Date of presentation: Wednesday, 24 July
Time of presentation: 12:00-13:00 CEST
|
Pre-exposure prophylaxis (PrEP) product choice of participants in HPTN 083
|
M. E. Clement |
TUPEC184 |
Poster
Date of presentation: Tuesday, 23 July
Time of presentation: 12:00-13:00 CEST
|
“Everyone should have access to it”: Perspectives on PrEP product choice and implementation from MSM and TGW in an injectable PrEP trial |
C. Psaros |
WEPEC206 |
Poster
Date of presentation: Wednesday, 24 July
Time of presentation: 12:00-13:00 CEST
|
Pipeline |
|||
Phase 1 study of VH4524184 (VH-184), a new third-generation integrase strand transfer inhibitor (INSTI) with a unique resistance profile |
L. Rogg
|
OAB26 |
Oral
Session date: Thursday, 25 July
Session time: 15:00-16:00 CEST
|
Preclinical assessments of a cabotegravir prodrug predicting human dosing durations of >6 months |
M. Baker |
WEPEA028 |
Poster
Date of presentation: Wednesday, 24 July
Time of presentation: 12:00-13:00 CEST
|
Pre-clinical profiles of HIV-1 capsid inhibitors VH4004280 (VH-280) and VH4011499 (VH-499) |
C. Wang |
WEPEA027 |
Poster
Date of presentation: Wednesday, 24 July
Time of presentation: 12:00-13:00 CEST
|
Clinical pharmacokinetics and safety of orally administered VH4004280 (VH-280), a novel HIV-1 capsid inhibitor, in healthy volunteers |
R. Griesel |
THPEB093 |
Poster
Date of presentation: Thursday, 25 July
Time of presentation: 12:00-13:00 CEST
|
Clinical pharmacokinetics and safety of orally administered VH4011499 (VH-499), a novel HIV-1 capsid inhibitor, in healthy volunteers |
N. Thakkar |
WEPEB105 |
Poster
Date of presentation: Wednesday, 24 July
Time of presentation: 12:00-13:00 CEST
|
Above Brand |
|||
Detailed modelling of viremia exposure does not independently predict cardiovascular disease in people with HIV |
O. Elvstam |
OAB34 |
Oral
Session date: Friday, 26 July 2024
Session time: 10:30-11:30 CEST
|
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.
Please consult the full Summary of Product Characteristics for all the safety information: Dovato 50 mg/300 mg film-coated tablets.
About Vocabria
Vocabria (cabotegravir) injection is indicated - in combination with rilpivirine injection - for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the non-nucleoside reverse transcriptase inhibitors (NNRTI) and integrase inhibitor (INI) class.
Vocabria tablets are indicated - in combination with rilpivirine tablets - for the short-term treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class for:
- oral lead in to assess tolerability of Vocabria and rilpivirine prior to administration of long acting Vocabria injection plus long acting rilpivirine injection.
- oral therapy for adults who will miss planned dosing with Vocabria injection plus rilpivirine injection.
Vocabria tablets are only indicated for treatment of HIV-1 in combination with rilpivirine tablets, therefore, the prescribing information for Edurant tablets should also be consulted for recommended dosing.
Please consult the full Summary of Product Characteristics for all the safety information: Vocabria 400mg/600 mg prolonged-release suspension for injection and Vocabria 30 mg film-coated tablets.
About Rekambys
Rekambys is indicated - in combination with cabotegravir injection - for the treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with, agents of the NNRTI and INI class.
Rekambys should always be co-administered with a cabotegravir injection. The prescribing information for cabotegravir injection should be consulted for recommended dosing. Rekambys may be initiated with oral lead-in or without (direct to injection).
Please consult the full Summary of Product Characteristics for all the safety information: Rekambys 600mg/900 mg prolonged-release suspension for injection.
About Apretude
Apretude is a medicine used for preventing sexually transmitted HIV-1 infection (pre-exposure prophylaxis or PrEP) in adults and adolescents weighing at least 35 kg who are at high risk of being infected. It should be used in combination with safer sex practices, such as using condoms. Apretude contains the active substance cabotegravir.
Please consult the full Summary of Product Characteristics for all the safety information: Apretude 600 mg prolonged-release suspension for injection.
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 SEIMC-GeSIDA Foundation (FSG)
The SEIMC-GeSIDA Foundation (FSG) was founded by 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 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. For more information on the SEIMC-GeSIDA Foundation (FSG), please visit https://fundacionseimcgesida.org/en/quienes-somos/.
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.
Registered in |
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GSK plc |
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ViiV Healthcare Limited |
No. 3888792 |
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No. 06876960 |
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Registered Office: |
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GSK plc |
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ViiV Healthcare Limited |
980 Great West Road |
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GSK Medicines Research Centre |
Brentford, |
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Gunnels Wood Road, |
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TW8 9GS |
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SG1 2NY |
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) randomized clinical trial. Presented at the 25 International AIDS Conference. July 2024.
2 C.P. Rolle, et al. Efficacy, safety and tolerability of switching to dolutegravir/lamivudine in virologically suppressed adults living with HIV on bictegravir/emtricitabine/tenofovir alafenamide - 48-week results from the DYAD study. Presented at the 25 International AIDS Conference. July 2024.
3 J. Slim, et al. Switch to dolutegravir/lamivudine (DTG/3TC) in people living with HIV-1 suppressed on bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF): 96-week final analysis from the SOUND study. Presented at the 25 International AIDS Conference. July 2024.
4 S. Delany-Moretlwe, et al. Initial evaluation of CAB-LA Safety during pregnancy in the HPTN 084 open-label extension. Presented at the 25th International AIDS Conference. July 2024.
5 M. Marzinke, et al. Evaluation of Long-Acting Cabotegravir (CAB-LA) Pharmacokinetics During Pregnancy: A Sub-Study Analysis of the HPTN 084 Open Label Extension. Presented at the 25th International AIDS Conference. July 2024.
6 L. Rogg, et al. Phase 1 study of VH4524184 (VH-184), a new third-generation integrase strand transfer inhibitor (INSTI) with a unique resistance profile. Presented at the 25th International AIDS Conference. July 2024.
7 S. Schneider, et al. Clinical outcomes at Month 12 after initiation of cabotegravir and rilpivirine long acting (CAB+RPV LA) in an observational real-world study (BEYOND). Presented at the 25th International AIDS Conference. July 2024.
8 W. Valenti, et al. Perspectives of people with HIV (PWH) 12 months following a switch to cabotegravir and rilpivirine long-acting (CAB+RPV LA) in an observational real-world US study (BEYOND). Presented at the 25th International AIDS Conference. July 2024.
9 CJ. Oldenbüttel, et al. 12-Month outcomes of cabotegravir plus rilpivirine long-acting every 2 months in a real-world setting: effectiveness, adherence to injections, and patient-reported outcomes from people with HIV-1 in the German CARLOS cohort. Presented at the 25th International AIDS Conference. July 2024.
10 A. Pozniak, et al. Real-world utilization and effectiveness of long-acting cabotegravir + rilpivirine in virologically suppressed treatment experienced individuals in
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FAQ
What is the PASO-DOBLE study comparing Dovato (DTG/3TC) and Biktarvy (BIC/FTC/TAF) at AIDS 2024?
What new data will be presented on Apretude (cabotegravir long-acting injectable) for PrEP at AIDS 2024?
What pipeline data will ViiV Healthcare present at AIDS 2024?