People Living with HIV-1 (PLHIV) are an important group of patients attending their specialist's and continue growing thanks to efficacy antiretroviral treatment (ART), allowing them to stabilize the HIV-infection and to live a normal life despite the infection. The present study is encouraged to demonstrate that efficacy and security of CAB LA + RPV LA treatment's on this population remains the same compared to younger population of patients. This study also registers some metabolic and hepatic parameters to observe a hypothetical improvement on these parameters, as the population may suffer more comorbidities than younger population and therefore tolerability and convenience gains a huge importance on them. Psychosocial aspects are also very important in these patients as these patients may suffer social stigma, and therefore suffering certain psychological disorders.

Start Date30 Jan 2025

Sponsor / Collaborator

ViiV Healthcare Ltd.

NCT06501781 / Not yet recruitingNot ApplicableIIT

Peer Behavioral Activation Utilization to Address Structural Racism and Discrimination and Improve HIV Outcomes in High-Risk, Substance-Using Populations

This randomized Type 1 hybrid effectiveness-implementation trial (N=186) will evaluate the effectiveness and implementation of a peer-delivered problem solving and behavioral activation intervention for adherence to LAI-PrEP/ART ("Peer Activate-LAI") compared to enhanced treatment as usual (ETAU) for a largely Black, substance-using population living with or at high risk for HIV. Specific aims are to:
Aim 1: Evaluate the effectiveness of Peer Activate-LAI over 12-months on: a) LAI-PrEP/ART adherence (primary; receipt of all 6 maintenance injections within 7-day window); and b) substance use (secondary; WHOASSIST, urine toxicology); and c) Explore the moderating role of SRD-related factors (exploratory)
Aim 2: To evaluate the implementation of Peer Activate-LAI including feasibility, acceptability, fidelity, and adoption guided by RE-AIM and Proctor's model,12,13 assessed using mixed methods, including a rapid ethnographic assessment of how SRD-related factors may affect implementation.
Aim 3: To evaluate the economic viability of Peer Activate-LAI, including a) cost of implementation and sustainment, and b) cost-effectiveness from multiple stakeholder perspectives.
This study will inform a potentially scalable, cost-effective model for facilitating effective adherence to LAI formulations of PrEP/ART within Black, substance-using populations with multiple minority identities who to date have had limited support for improving LAI adherence for HIV treatment and prevention.

Start Date01 Jan 2025

Sponsor / Collaborator

University of Maryland Baltimore

NCT06336434 / Not yet recruitingPhase 1/2IIT

Phase I/II Study of the Pharmacokinetics and Safety of Long-Acting Injectable Cabotegravir and Rilpivirine in Pregnant and Postpartum Adults With HIV-1

This is a Phase I/II, multicenter, open-label, non-randomized study with four groups to characterize the pharmacokinetics and safety of Cabotegravir (CAB) and Rilpivirine (RPV) long-acting injectable (LA) during pregnancy and postpartum among people with HIV-1 viral suppression and their infants.

Start Date24 Sep 2024

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

100 Clinical Results associated with Cabotegravir sodium

100 Translational Medicine associated with Cabotegravir sodium

100 Patents (Medical) associated with Cabotegravir sodium

540

Literatures (Medical) associated with Cabotegravir sodium

01 Dec 2024·HIV Research & Clinical Practice

Impact of switching to injectables cabotegravir and rilpivirine on sleep disturbances in a cohort of people living with HIV.

Article

Author: Sasset, Lolita ; Agostini, Elena ; Gardin, Samuele ; Presa, Nicolò ; Mazzitelli, Maria ; Leoni, Davide ; Scaglione, Vincenzo ; Vania, Eleonora ; Cattelan, Annamaria

BACKGROUND:

Recently, injectable cabotegravir/rilpivirine (ICAB/RPV) became available for HIV treatment. However, there are no real-life data on the impact of switching to ICAB/RPV on sleep disturbances (SD). Therefore, we aimed at assessing and investigating this aspect in our cohort.

METHODS:

A SD multidimensional assessment (Epworth Sleepiness scale, Insomnia severity Index, Berlin Questionnaire, and Pittsburg Sleep Quality Index, PSQI) was performed to all people who consented before starting ICAB/RPV and 12 wk after the switch. Demographics, life-style habits, laboratory, and clinical data were collected from medical health records.

RESULTS:

To June 2023, 46 people were included, 76.1% males, with a median age of 48.5 (IQR: 41-57), 50% had multimorbidity, 13% was on polypharmacy. Median age with HIV and CD4 + T cell count nadir were 10 (5-19.5) years and 360 (205-500) cell/mm³, respectively. The reason to start a long-acting strategy was person's choice in all cases. Baseline antiretroviral regimens were mostly: tenofovir alafenamide/emtricitabine/rilpivirine (39.1%) and dolutegravir/lamivudine (32.6%). No significant changes were observed in any of the scores for each questionnaire, but for a worsening PSQI. 37% people reported a subjectively improved sleep quality, even if statistically significant changes were not observed in almost all the sleep parameters.

CONCLUSIONS:

To the best of our knowledge, this is the first study exploring impact of switching to ICAB/RPV on SD. Despite integrase inhibitor have been associated with SD, we did not observed a negative impact on sleep quality after the switch to ICAB/RPV. More studies and with larger number of people are necessary to confirm our results.

01 Dec 2024·JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES

Acceptability of Long-Acting Cabotegravir + Rilpivirine in a Large, Urban, Ambulatory HIV Clinic

Article

Author: Luc, Casey Morgan ; Huhn, Gregory ; Herrera, Kara ; Pérez, Sarah ; Max, Blake ; Dworkin, Mark S.

Background::

Outside of randomized controlled trials, there are limited data regarding the acceptability of injectable long-acting cabotegravir + rilpivirine (LA-CAB+RPV) among persons living with HIV. To evaluate acceptability, we described participant-reported outcomes of LA-CAB+RPV among a population underrepresented in randomized controlled trials.

Setting::

Ruth M. Rothstein Core Center (CORE), large urban HIV clinic in Chicago, IL, USA.

Methods::

We interviewed persons living with HIV prescribed LA-CAB+RPV who receive primary care at CORE. Participant-reported outcome endpoints included treatment satisfaction, reasons for switching to LA-CAB+RPV, tolerability of injections, and unexpected effects of LA-CAB+RPV. Mean and standard deviations (mean ± SD) and proportions (%) are reported.

Results::

Among respondents (N = 150), 67% identified as non-Hispanic Black, 24% Hispanic, 56% male; the average age was 43 years (SD: 13.2), and 37% were ≥50 years old. Most respondents (93%) completed ≥3 injection appointments at the time of interview. The most common reasons for switching to LA-CAB+RPV were no longer wanting to take pills (89%) and trouble taking their pills daily (58%). Treatment satisfaction was high (6.7 ± 0.5 out of 7). Two-thirds (61%) reported an unexpected aspect of their life improved. Pain from injections was common (89%), with a mean pain score of 4.3 out of 10. Among those reporting pain, half (47%) reported that pain decreased after initial injection. Among participants reporting pain score >6 (n = 36), most (78%) reported no improvement since initial injection.

Conclusions::

We found high treatment satisfaction with LA-CAB+RPV in a diverse population. Participants reported moderate injection pain, which improved with time. Results suggest injectable LA-CAB+RPV will be met with acceptability across diverse participant populations.

01 Nov 2024·AIDS

CD4+/CD8+ improvement after switch from a second-generation integrase inhibitor regimen to long-acting cabotegravir and rilpivirine

Article

Author: Lolatto, Riccardo ; Diotallevi, Sara ; Nozza, Silvia ; Castagna, Antonella ; Gianotti, Nicola ; Muccini, Camilla

Our study assessed the CD4+/CD8+ ratio in people with HIV (PWH) switching from a second-generation integrase inhibitor regimen to long-acting cabotegravir (CAB) and rilpivirine (RPV). Over one year, we observed a significant improvement in the CD4+/CD8+ ratio; In addition, our data showed that time spent in CAB+RPV was significantly associated with an increased CD4+/CD8+ ratio. These findings suggest that long-acting therapy may enhance immune recovery, also in treatment-experienced PWH.

News (Medical) associated with Cabotegravir sodium

17 Oct 2024

·pipelinereview.com

ViiV Healthcare Shows More Than 99% Effectiveness in Real-World Studies for Apretude (Cabotegravir Long-Acting), the Only Approved Long-Acting HIV PrEP, in Data Presented at IDWeek 2024

LONDON, UK I October 16, 2024 I ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced the presentation of new real-world evidence and implementation data showing the effectiveness, adherence, and quality-of-life improvement of Apretude (cabotegravir long-acting (CAB LA)) for HIV pre-exposure prophylaxis (PrEP). The data will be presented at IDWeek 2024 , being held in Los Angeles, California from 16 – 19 October. Findings from two real-world evidence studies (from OPERA and Trio Health cohorts) showed more than 99% effectiveness of CAB LA for PrEP in nearly 1,300 individuals. In the PILLAR implementation study, reductions were shown in stigma and anxiety among the 200 individuals using the long-acting injectable PrEP option. Harmony P. Garges, M.D., MPH, Chief Medical Officer at ViiV Healthcare, said: “The findings presented at IDWeek 2024 continue to support the strong and sustained effectiveness of Apretude for people in real life, outside the controlled environment of a clinical trial. The results of the studies from OPERA and Trio cohorts add to the growing body of evidence generated over the last three years, showing CAB LA for PrEP is a highly effective option for HIV prevention. We believe long-acting options have the potential to be transformative in increasing uptake among a broad range of people that could benefit from PrEP and are critical to ending the HIV epidemic.” Trio Health cohort shows CAB LA for PrEP’s effectiveness in the real world with zero cases of HIV acquisition during follow-up 1 New data from the Trio Health cohort shows the real-world use of CAB LA for PrEP in preventing HIV acquisition and adherence, among 474 individuals in the U.S. The analysis identified a diverse population of cis- and transgender male and female individuals initiating CAB LA for PrEP from electronic health records between December 2021 through January 2024. Findings from the cohort showed that there were zero HIV diagnoses identified during follow-up among participants taking CAB LA for PrEP. Eighty-three percent persisted on CAB LA for PrEP injections at the time of analysis, and injections were also administered on time for most of the initiators. Of the 396 participants with continuation injections, 33% experienced delays with a median of one delayed injection and median delay of 12 days [IQR: 3-29]. Adherence to CAB LA for PrEP was high, with only 3% of participants experiencing a missed injection. OPERA study highlights high adherence and effectiveness of CAB LA for PrEP 2 Real-world findings from the OPERA study provide insights into injection timing, adherence, and effectiveness among individuals using CAB LA for PrEP in the U.S.. The OPERA study reported findings from a large, diverse U.S. cohort, which included 764 individuals using CAB LA for PrEP, 29% of whom are Black and 29% Hispanic. CAB LA for PrEP was effective in 99.7% of individuals (762 of 764 were not diagnosed with HIV during the follow-up period). There were two cases of HIV (0.3%) observed among the CAB LA for PrEP initiators. These cases could not be directly linked to the regimen due to its discontinuation in one case and inconsistent testing in the other case. Eighty-five percent of individuals taking CAB LA for PrEP had complete initiation of the regimen (i.e. completed their first two initiation injections 60 or less days apart from each other). Sixty-nine percent of these complete initiators received all of their continuation injections on time. While some injection delays were observed among those with complete initiation, most were short, with a median delay of three days from the target date. PILLAR implementation study shows CAB LA for PrEP may help address key PrEP challenges of stigma and anxiety 3 New findings from the PILLAR trial explore the experiences of more than 200 men who have sex with men (MSM) and transgender men (TGM) who initiated CAB LA for PrEP after previous experience with daily oral PrEP. PILLAR is a phase 4 implementation trial assessing the integration of CAB LA for PrEP across 17 U.S. clinics among a diverse population of MSM and TGM, 23% of whom are Black and 39% Hispanic/Latino. The six-month findings from the PILLAR trial showed that individuals taking CAB LA for PrEP reported lower rates of PrEP stigma and anxiety compared to their prior oral PrEP experience, and that the long-acting injectable was feasible, acceptable, and convenient for their life. When recounting their oral PrEP experience at the initiation of the trial, 15% of participants had worried about privacy while taking oral PrEP, 24% felt they had to hide their oral PrEP from others, and 29% expressed worry about stigma from taking oral PrEP. After initiating CAB LA for PrEP and completing surveys at month six of the trial, <1% of participants reported concerns about privacy and only 1% expressed worry about stigma while taking CAB LA for PrEP. Participants who completed interviews noted CAB LA for PrEP reduced the stress and fear of missing a PrEP dose, while offering confidence of protection from HIV. While 45% of participants reported injection site reactions (ISRs), 86% of participants returned to daily activities the same day and few reported being bothered by injection pain (8%). These individuals who had been initially bothered by injection pain reported that pain decreased over subsequent injections. CAB LA for PrEP demonstrated high levels of acceptability among users, with mean acceptability scores increasing from 4.4 at baseline (SD: 0.69) to 4.6 at six months (SD: 0.61), with interviewees noting that CAB LA for PrEP was convenient for their life. This positive experience was supported by flexible clinic scheduling, transportation assistance, and the use of virtual appointments, all of which were identified as valuable facilitators of adherence. These studies demonstrate ViiV Healthcare’s commitment to generating robust real-world evidence for CAB LA for PrEP, furthering the study of its implementation, and advancing the understanding of its impact on diverse communities who can benefit from HIV prevention. Further research will continue to explore the long-term benefits of CAB LA for PrEP and optimise its use. APRETUDE (cabotegravir) extended-release injectable suspension Professional Indication and Important Safety Information INDICATION APRETUDE is indicated for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents weighing at least 35 kg who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating APRETUDE (with or without an oral lead-in with oral cabotegravir) for HIV-1 PrEP. IMPORTANT SAFETY INFORMATION BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF APRETUDE FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED HIV-1 INFECTION Individuals must be tested for HIV-1 infection prior to initiating APRETUDE or oral cabotegravir, and with each subsequent injection of APRETUDE, using a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection. Drug-resistant HIV-1 variants have been identified with use of APRETUDE by individuals with undiagnosed HIV-1 infection. Do not initiate APRETUDE for HIV-1 PrEP unless negative infection status is confirmed. Individuals who acquire HIV-1 while receiving APRETUDE for PrEP must transition to a complete HIV-1 treatment regimen. CONTRAINDICATIONS WARNINGS AND PRECAUTIONS Comprehensive Management to Reduce the Risk of HIV-1 Infection: Potential Risk of Resistance with APRETUDE: Long-Acting Properties and Potential Associated Risks with APRETUDE: Hypersensitivity Reactions: Hepatotoxicity: Depressive Disorders: Risk of Reduced Drug Concentration of APRETUDE Due to Drug Interactions: ADVERSE REACTIONS The most common adverse reactions (incidence ≥1%, all grades) with APRETUDE were injection site reactions, diarrhea, headache, pyrexia, fatigue, sleep disorders, nausea, dizziness, flatulence, abdominal pain, vomiting, myalgia, rash, decreased appetite, somnolence, back pain, and upper respiratory tract infection. DRUG INTERACTIONS USE IN SPECIFIC POPULATIONS 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. SOURCE: GlaxoSmithKline

Clinical ResultPhase 3

17 Oct 2024

·www.biospace.com

GSK, ViiV Tout 99% Effectiveness for Long-Acting PrEP as Gilead Gains Ground

Poznan, Poland – October 29, 2020: The Glaxosmithkline headquarters office building in Poznan. LOGO. GaxoSmithKline also called GSK is a British pharmaceutical company. iStock, Wirestock Real-world evidence show that GSK and ViiV Healthcare’s long-acting pre-exposure prophylaxis Apretude can prevent nearly all HIV infections, while rival Gilead Sciences is moving quickly toward an approval for a twice-yearly option. GSK and ViiV Healthcare’s pre-exposure prophylaxis drug Apretude is more than 99% effective at preventing HIV infections , according to real-world results being presented at this week’s IDWeek 2024 conference. The results came from the real-world OPERA and Trio Health cohorts, which together enrolled almost 1,300 individuals, and “support the strong and sustained effectiveness of Apretude … outside the controlled environment of a clinical trial,” ViiV CMO Harmony Garges said in a statement. These data “add to the growing body of evidence generated over the last three years, showing [Apretude] for PrEP is a highly effective option for HIV prevention.” In Trio Health, which involved both cis- and transgender male and female participants, none of the patients taking Apretude PrEP were diagnosed with HIV during follow-up. Adherence to the injection was high, with only 3% of participants missing a dose. Similar findings were obtained from OPERA, which showed that 762 of 764 patients on Apretude remained free of HIV during follow-up, resulting in a 99.7% effectiveness rate. Of the two patients who were diagnosed with HIV, one had discontinued Apretude while the other had inconsistent testing. According to ViiV, the HIV diagnoses in these patients “could not be directly linked to the regimen.” GSK and ViiV are also presenting data from the PILLAR implementation study at IDWeek 2024, touting quality of life improvements in men who have sex with men and transgender men on Apretude. Six-month findings from PILLAR showed that Apretude lowered PrEP stigma and anxiety among study participants, compared with oral PrEP. Participants also found the long-acting injectable to be feasible, acceptable and convenient. Apretude is an intramuscularly administered HIV-1 integrase strand transfer inhibitor. It works by preventing the virus’ genetic material from being integrated into the host DNA, disrupting the HIV replication cycle. First approved in 2021 , Apretude is the first long-acting PrEP to hit the U.S. market. GSK and ViiV are working to extend the dosing interval of Apretude, which is currently approved to be given every two months. Meanwhile, its top HIV competitor Gilead is moving quickly toward an approval for a twice-yearly option. In June 2024, Gilead released data from the Phase III PURPOSE 1 study, announcing that its investigational PrEP shot lenacapavir showed 100% efficacy in preventing HIV in cisgender women. Gilead bolstered these findings last month with an interim readout from PURPOSE 2, which showed that the twice-yearly injection reduced HIV infections by 96% in a diverse study population —including cisgender men, transgender men, transgender women and gender non-binary individuals who have sex with partners assigned male at birth. Of the 2,180 participants, only two patients were diagnosed with HIV, suggesting that 99.9% of participants remained free of the infection at the time of the analysis. Gilead is working toward regulatory filings by the end of the year, with a potential launch in 2025.

Clinical ResultPhase 3Drug Approval

16 Oct 2024

·www.gsk.com

ViiV Healthcare shows more than 99% effectiveness in real-world studies for Apretude (cabotegravir long-acting), the only approved long-acting HIV PrEP, in data presented at IDWeek 2024

16 October 2024 Studies from OPERA and Trio cohorts provide further real-world evidence supporting CAB LA for PrEP’s high effectiveness and adherence in preventing HIV acquisition Patient-reported results for CAB LA for PrEP in the PILLAR implementation study showed a reduction in stigma and anxiety – common challenges associated with daily oral PrEP 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 today shared the presentation of new real-world evidence and implementation data showing the effectiveness, adherence, and quality-of-life improvement of Apretude (cabotegravir long-acting (CAB LA)) for HIV pre-exposure prophylaxis (PrEP). The data will be presented at IDWeek 2024, being held in Los Angeles, California from 16 – 19 October. Findings from two real-world evidence studies (from OPERA and Trio Health cohorts) showed more than 99% effectiveness of CAB LA for PrEP in nearly 1,300 individuals. In the PILLAR implementation study, reductions were shown in stigma and anxiety among the 200 individuals using the long-acting injectable PrEP option. Harmony P. Garges, M.D., MPH, Chief Medical Officer at ViiV Healthcare, said: “The findings presented at IDWeek 2024 continue to support the strong and sustained effectiveness of Apretude for people in real life, outside the controlled environment of a clinical trial. The results of the studies from OPERA and Trio cohorts add to the growing body of evidence generated over the last three years, showing CAB LA for PrEP is a highly effective option for HIV prevention. We believe long-acting options have the potential to be transformative in increasing uptake among a broad range of people that could benefit from PrEP and are critical to ending the HIV epidemic.” Trio Health cohort shows CAB LA for PrEP’s effectiveness in the real-world with zero cases of HIV acquisition during follow-up1 New data from the Trio Health cohort shows the real-world use of CAB LA for PrEP in preventing HIV acquisition and adherence, among 474 individuals in the U.S.. The analysis identified a diverse population of cis- and transgender male and female individuals initiating CAB LA for PrEP from electronic health records between December 2021 through January 2024. Findings from the cohort showed that there were zero HIV diagnoses identified during follow-up among participants taking CAB LA for PrEP. 83% percent persisted on CAB LA for PrEP injections at the time of analysis, and injections were also administered on time for most of the initiators. Of the 396 participants with continuation injections, 33% experienced delays with a median of one delayed injection and median delay of 12 days [IQR: 3-29]. Adherence to CAB LA for PrEP was high, with only 3% of participants experiencing a missed injection. OPERA study highlights high adherence and effectiveness of CAB LA for PrEP2 Real-world findings from the OPERA study provide insights into injection timing, adherence, and effectiveness among individuals using CAB LA for PrEP in the U.S.. The OPERA study reported findings from a large, diverse U.S. cohort, which included 764 individuals using CAB LA for PrEP, 29% of whom are Black and 29% Hispanic. CAB LA for PrEP was effective in 99.7% of individuals (762 of 764 were not diagnosed with HIV during the follow-up period). There were two cases of HIV (0.3%) observed among the CAB LA for PrEP initiators. These cases could not be directly linked to the regimen due to its discontinuation in one case and inconsistent testing in the other case. 85% of individuals taking CAB LA for PrEP had complete initiation of the regimen (i.e. completed their first two initiation injections 60 or less days apart from each other). 69% of these complete initiators received all of their continuation injections on time. While some injection delays were observed among those with complete initiation, most were short, with a median delay of three days from the target date. PILLAR implementation study shows CAB LA for PrEP may help address key PrEP challenges of stigma and anxiety3 New findings from the PILLAR trial explore the experiences of more than 200 men who have sex with men (MSM) and transgender men (TGM) who initiated CAB LA for PrEP after previous experience with daily oral PrEP. PILLAR is a phase 4 implementation trial assessing the integration of CAB LA for PrEP across 17 U.S. clinics among a diverse population of MSM and TGM, 23% of whom are Black and 39% Hispanic/Latino. The six-month findings from the PILLAR trial showed that individuals taking CAB LA for PrEP reported lower rates of PrEP stigma and anxiety compared to their prior oral PrEP experience, and that the long-acting injectable was feasible, acceptable, and convenient for their life. When recounting their oral PrEP experience at the initiation of the trial, 15% of participants had worried about privacy while taking oral PrEP, 24% felt they had to hide their oral PrEP from others, and 29% expressed worry about stigma from taking oral PrEP. After initiating CAB LA for PrEP and completing surveys at month six of the trial, <1% of participants reported concerns about privacy and only 1% expressed worry about stigma while taking CAB LA for PrEP. Participants who completed interviews noted CAB LA for PrEP reduced the stress and fear of missing a PrEP dose, while offering confidence of protection from HIV. While 45% of participants reported injection site reactions (ISRs), 86% of participants returned to daily activities the same day and few reported being bothered by injection pain (8%). These individuals who had been initially bothered by injection pain reported that pain decreased over subsequent injections. CAB LA for PrEP demonstrated high levels of acceptability among users, with mean acceptability scores increasing from 4.4 at baseline (SD: 0.69) to 4.6 at six months (SD: 0.61), with interviewees noting that CAB LA for PrEP was convenient for their life. This positive experience was supported by flexible clinic scheduling, transportation assistance, and the use of virtual appointments, all of which were identified as valuable facilitators of adherence. These studies demonstrate ViiV Healthcare's commitment to generating robust real-world evidence for CAB LA for PrEP, furthering the study of its implementation, and advancing the understanding of its impact on diverse communities who can benefit from HIV prevention. Further research will continue to explore the long-term benefits of CAB LA for PrEP and optimise its use. 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. Trademarks are owned by or licensed to the ViiV Healthcare group of companies. 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 Q2 Results for 2024. References You might also like

Clinical ResultPhase 3Drug Approval

100 Deals associated with Cabotegravir sodium

External Link

KEGG	Wiki	ATC	Drug Bank
D10548 D10549	Cabotegravir sodium	J05AR	DB11751

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
HIV Infections	CA	ViiV Healthcare Ltd.	21 Sep 2020

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
HIV-Associated Lipodystrophy Syndrome	Phase 1	US	GSK Plc	01 May 2013
Hepatitis	Phase 1	US	ViiV Healthcare Ltd.	01 Nov 2011
Herpesviridae Infections	Phase 1	-	GSK Plc	01 Sep 2010

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


OPERA (BusinessWire) Manual	Not Applicable	HIV Infections	-	Apretude (cabotegravir long-acting (CAB LA))	mscraubtgu(orhznyltnc) = zhsujcsfzq zxntswwdqh (uwochhojfm )	Positive	16 Oct 2024
NCT04824131 (CTgov)	Phase 2	HIV Infections	55	Cabotegravir (Cabotegravir Long Acting)	uldtstrmtc(hpwrcqzcpg) = piqpjwwhdo rveivfkcta (mzvmdkvucp, bivwqynypq - wutjdzpvst) View more	-	30 Jul 2024
				CAB (Step 1 - CAB LA Oral Phase)	gvyjnvgvlw(lapzfeacjp) = gierpbrdxw wzlanciiyd (ksaeoodabe, dwduwnyzib - orpjyssjdt) View more
NCT03299049 \| NCT02951052 \| NCT02938520 (Pubmed \| J Infect Dis)	Phase 3	HIV Infections Maintenance	1,245	CAB + RPV LA every 4 week dosing	cytcrvjmgs(wlzfmqkbbu) = karhecqlbe pbwlcaygqh (sxqeqgghex )	Positive	25 Jul 2024
				CAB + RPV LA every 8 week dosing	cytcrvjmgs(wlzfmqkbbu) = lvzbcoizle pbwlcaygqh (sxqeqgghex )
NCT02720094 (CTgov)	Phase 2/3	HIV Infections	4,570	Cabotegravir (Cabotegravir)	rkckjyphla(amyxawsmyu) = qywvdttfpl ybywgcxalp (rbcylglgzl, ljnyuewfsz - qwktlxcqec) View more	-	24 Nov 2023
				FTC+TDF (TDF/FTC)	rkckjyphla(amyxawsmyu) = ebrfdrywfr ybywgcxalp (rbcylglgzl, qtjcsocvlb - aybtjwitvz) View more
NCT04399551 (CARISEL, CTgov)	Phase 3	HIV Infections	437	Continuous Quality Improvement (CQI) calls	ukxpvkpfan(fuipoqgumc) = nawfqurplv iuhtlseaxb (lqkhvbzqse, qixceoekqt - ohwomgvueg)	-	19 May 2023
NCT03164564 (HPTN 084, CTgov)	Phase 3	HIV Infections	3,224	Oral CAB+CAB LA+Oral TDF/FTC (Arm A: CAB + Placebo TDF/FTC + CAB LA)	yxokvlcqha(ejeqemyani) = pdkhozlxfb vixwdamybs (eixxsjirgs, cetphmoihu - jibplfacaz) View more	-	28 Mar 2023
				Placebo for CAB LA+Oral TDF/FTC (Arm B: TDF/FTC + Placebo CAB + Placebo CAB LA)	yxokvlcqha(ejeqemyani) = ztfzqxfsnb vixwdamybs (eixxsjirgs, vptocrxprb - rregbbfxpo) View more
NCT04399551 (CARISEL, Corporate Publications) Manual	Phase 3	HIV Infections	437	Cabotegravir+Rilpivirine Hydrochloride	plifdhwzse(tqtokkidwz) = kqetgvucdk iwhgxlbwhg (tcsgdbyvqz ) View more	Positive	24 Oct 2022
NCT03164564 (HPTN 084, Corporate Publications) Manual	Phase 3	HIV Infections	3,224	Cabotegravir	xxfuirkwau(nzohuiousk) = suvvsqstde lddvzcbhij (xoitqwrdyq ) View more	Superior	28 Jul 2022
				Emtricitabine+Tenofovir	xxfuirkwau(nzohuiousk) = gkrpyydpxh lddvzcbhij (xoitqwrdyq ) View more
NCT03164564 (HPTN 084, Pubmed) Manual	Phase 3	HIV Infections	3,224	Placebo+cabotegravir	bplnqvhsqg(ufyjdabeli) = imltxqwjps ddsvntfvme (qzskomivqx ) View more	Superior	01 Apr 2022
				Placebo+tenofovir diphosphate plus emtricitabine	bplnqvhsqg(ufyjdabeli) = pjrfrzmlmv ddsvntfvme (qzskomivqx ) View more
NCT03639311 (Pubmed) Manual	Phase 2	HIV Infections	97	CAB+RPV long-acting	lkbpzageiv(hnysihclug) = eknckwyshp thpqzykfta (wtzltfhrxh ) View more	Positive	01 Feb 2022
				dolutegravir/RPV	lkbpzageiv(hnysihclug) = ephbqfrvuf thpqzykfta (wtzltfhrxh ) View more

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