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 Date01 May 2025

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

NCT06704204

/ Not yet recruitingNot ApplicableIIT

Long-acting Injectable Antiretroviral Treatment to Improve HIV Treatment Among Justice-involved Persons Being Released to the Community (Study #3; Aim 2 Injectable CAB/RPV Pilot)

The federal research award entitles "Long-acting injectable antiretroviral treatment to improve HIV treatment among justice-involved persons being released to the community" aims to Conduct interviews with justice and treatment experienced PWH (n=20), and carceral and community key stakeholders (n=20), to obtain guidance on the development and implementation of a protocol to transition PWH with viral suppression on oral ART to LAI ART in prison with continuation during community re-entry; develop an initial LAI ART community re-entry protocol based on Aim 1 findings and conduct an open label pilot study. Post-release follow up will occur for three months among 20-30 incarcerated PWH eligible for LAI ART who are near release from prison in order to optimize protocol procedures including participant recruitment, initiation of LAI ART in prison, transition of LAI ART to community providers, and to pilot study retention methods and assessments, including post-release HIV viral loads and urine drug testing, during the follow-up period.

Start Date01 Feb 2025

Sponsor / Collaborator

The Miriam Hospital

[+1]

TCTR20240608002

/ RecruitingNot ApplicableIIT

Medical and practical eligibility for long-acting cabotegravir/rilpivirine in adolescents and young adults living with HIV in tertiary care clinic

Start Date26 Apr 2024

Sponsor / Collaborator-

100 Clinical Results associated with Rilpivirine Hydrochloride

100 Translational Medicine associated with Rilpivirine Hydrochloride

100 Patents (Medical) associated with Rilpivirine Hydrochloride

2,075

Literatures (Medical) associated with Rilpivirine Hydrochloride

15 Apr 2025·JAIDS Journal of Acquired Immune Deficiency Syndromes

Adherence and Forgiveness of Two Modern ART Regimens: Lamivudine/Dolutegravir and Emtricitabine/Tenofovir Alafenamide/Rilpivirine

Article

Author: Comi, Laura ; Blanchi, Sabrina ; Centorrino, Federica ; Maggiolo, Franco ; Di Biagio, Antonio ; Taramasso, Lucia ; Valenti, Daniela

Introduction:Few data are available on the forgiveness of 2-drug (2DR) or low-barrier 3-drug antiretroviral regimens. The aim of this study is to evaluate the real-life forgiveness of lamivudine/dolutegravir (3TC/DTG) and emtricitabine/tenofovir alafenamide/rilpivirine (FTC/TAF/RPV).Methods:A 2-center retrospective observational study enrolled all people with HIV treated with 3TC/DTG or FTC/TAF/RPV. Adherence was measured as the proportion of days covered (PDC) by drug supply. Binary logistic regression was used to test the impact of baseline variables and adherence on the achievement of virological suppression.Results:In total, 1258 adult people with HIV were enrolled, 368 in 3TC/DTG and 890 in FTC/TAF/RPV. Most were men (71%), with a median age of 51 years (IQR 43–58 years) and a median CD4 nadir of 305 cells/mcL (IQR 132–485). Median cohort follow-up was 4558 persons/year. Median adherence, as calculated from PDC, was of 0.98 (IQR 0.93–1). Regardless of the treatment group, a PDC of 0.8 was sufficient to achieve HIV-RNA levels below 200 copies/mL in almost all study participants. With the same level of adherence, >90% of study participants achieved HIV-RNA below 50 copies/mL. PDC (P < 0.0001), Italian origin (P < 0.0001), and male sex (P = 0.038) were significantly correlated with achieving <200 copies/mL.Conclusions:In this study, we found a similar and high level of forgiveness with the INSTI-based 2-drug regimen 3TC/DTG and the NNRTI-based 3-drug regimen FTC/TAF/RPV.

01 Apr 2025·JAIDS Journal of Acquired Immune Deficiency Syndromes

Weight and Metabolic Changes With Long-Acting Cabotegravir and Rilpivirine or Bictegravir/Emtricitabine/Tenofovir Alafenamide

Article

Author: Berni, Alessandro ; van Wyk, Jean ; Eu, Beng ; Sweet, Donna ; Sutton, Kenneth ; D'Amico, Ronald ; Patel, Parul ; Urbaityte, Rimgaile ; Van Dam, Cornelius N. ; Sutherland-Phillips, Denise ; Galindo Puerto, María José ; Batterham, Rachel ; Kinder, Clifford ; Antinori, Andrea ; Spreen, William ; Baugh, Bryan ; Zhang, Feifan ; Tan, Darrell H. S. ; Garges, Harmony P.

Background:Modest weight and lipid changes have been observed in cabotegravir plus rilpivirine long-acting (CAB + RPV LA) phase 3/3b studies. The SOLAR study included standardized evaluations of weight and metabolic changes in people living with HIV switching to CAB + RPV LA dosed every 2 months (Q2M) vs. continuing bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF).Setting:Phase 3b, randomized, open-label study conducted in 118 centers across 14 countries.Methods:Participants (n = 687) were randomized 2:1; 454 switched to CAB + RPV LA Q2M and 227 continued BIC/FTC/TAF. Participants who started lipid-modifying agents or underwent cosmetic procedures were excluded. We analyzed changes in body weight, body mass index (BMI), waist circumference (WC), hip circumference (HC), waist-to-height ratio (WHtR), waist-to-hip ratio (WHR), muscle mass, body fat, and proportion with insulin resistance or metabolic syndrome at 1 year.Results:Median (interquartile range) change in body weight from baseline was −0.40 kg (−2.95 to +2.10) and +0.05 kg (−2.30 to +1.95) in the LA and BIC/FTC/TAF arm, respectively. Median (interquartile range) changes in WC and HC were +0.06 cm (−4.50 to 4.00) and +0.00 cm (−4.00 to 3.97) in the LA arm, and +1.14 cm (−3.00 to 5.09) and +0.13 cm (−3.10 to 4.00) in the BIC/FTC/TAF arm. There were no clinically relevant changes in WHtR, WHR, or the proportion with metabolic syndrome or insulin resistance in either arm.Conclusions:Standardized changes in weight, BMI, and body composition were minor and similar between participant switching to CAB + RPV LA Q2M or continuing BIC/FTC/TAF, with no clinically relevant changes in metabolic syndrome or insulin resistance.

24 Mar 2025·Journal of Biomolecular Structure and Dynamics

Inhibition of respiratory syncytial virus by Daclatasvir and its derivatives: synthesis of computational derivatives as a new drug development

Article

Author: Afreen, Shagufta ; Mitra, Debanjan ; Abdalla, Mohnad ; Das Mohapatra, Pradeep K.

The most common cause of respiratory tract illness in newborns and young children is the respiratory syncytial virus (RSV). There is no approved vaccination or specific antiviral medication for RSV infections. Here, an attempt has been made to explore the potential of currently marketed drugs as well as their probable derivatives to improve the possibility of developing stronger medications against RSV. From the 100 synthetic drug compounds library, the best drug molecule was identified through drug-likeness properties, toxicity, molecular docking and molecular dynamics simulations. Molecular Mechanics Generalized Born Surface Area (MM-GBSA) was also a method that was applied in this study. Daclatasvir showed the highest binding energy and appeared as the best drug to inhibit matrix protein and a fusion protein of RSV. Based on Daclatasvir, 40 computational derivatives were made. D28, D34 and D40 showed far better results than the actual drug. Changes in lipophilicity character increase the binding energy of derivatives. Molecular dynamic simulations showed their non-deviated, non-fluctuated and stable complex formation with target proteins. The high number of amino acid contacts throughout the trajectory increases the stability and effectiveness of derivatives. The key to producing a novel medicine to eradicate RSV is provided by derivatives. Daclatasvir will be employed as a potential RSV inhibitor up until that point.Communicated by Ramaswamy H. Sarma.

News (Medical) associated with Rilpivirine Hydrochloride

12 Mar 2025

·pipelinereview.com

ViiV Healthcare’s investigational broadly neutralising antibody - N6LS - successfully maintains viral suppression in long-acting treatment of HIV

LONDON, UK I March 12, 2025 I ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced positive findings from the company’s EMBRACE phase IIb study. 1 The study found that N6LS (VH3810109 or VH109), given every four months in combination with monthly cabotegravir long-acting (CAB LA), successfully kept viral levels suppressed in adults living with HIV who were already stable on treatment. It was also well tolerated by participants. These results were presented today at the Conference on Retroviruses and Opportunistic Infections (CROI 2025) in San Francisco, U.S. Kimberly Smith, M.D., MPH, Head of Research & Development at ViiV Healthcare, said :”As leaders in long-acting injectable innovation, we are building on the positive patient and physician experience we have with Cabenuva and pioneering the next generation of long-acting treatment options. The EMBRACE study demonstrated that VH109, a CD4-binding broadly neutralising antibody, administered every four months with cabotegravir, achieved high efficacy and was well tolerated through six months. We’re looking forward to continuing the development of VH109 as a component of our future ultra long-acting regimens.” Results from the EMBRACE study at the six-month primary endpoint showed that 96% of participants receiving VH109 60mg/kg intravenously (IV) and 88% receiving VH109 3000mg subcutaneously (SC) with rHuPH20 maintained HIV-1 RNA levels below 50 copies/mL, compared to 96% in the standard-of-care group. VH109 was administered in both arms every four months, combined with monthly CAB LA. Confirmed virologic failure was observed in two participants from each VH109 group. Overall, 4% of the IV group and 6% of the SC group had HIV-1 RNA levels of 50 copies/mL or higher, compared to none in the standard-of-care group when measured at month six. VH109 was generally well tolerated, though infusion site reactions were more frequent with SC administration, occurring in 14% compared to none with IV administration. Adverse events specific to the use of study medication were reported in 64% of the IV group and 65% of the SC group, with 16% of participants in the SC group experiencing grade 3-4 adverse events (erythema). No participants in the IV group experienced a grade 3-4 adverse event. Based on the favourable results seen in the trial, ViiV Healthcare will be progressing a six-month IV formulation of VH109 in combination with CAB LA for further evaluation in an EMBRACE part two trial. About Cabenuva (cabotegravir + rilpivirine) Cabenuva is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years and older and weighing at least 35kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 c/ml) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. The complete regimen combines the integrase strand transfer inhibitor (INSTI) cabotegravir, developed by ViiV Healthcare, with rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) developed by Janssen Sciences Ireland Unlimited Company. Rilpivirine tablets are approved in the U.S. and when used with cabotegravir is indicated for short-term treatment of HIV-1 infection in adults and adolescents 12 years and older and weighing at least 35kg who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. INSTIs inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic disease. Rilpivirine is an NNRTI that works by interfering with an enzyme called reverse transcriptase, which stops the virus from multiplying. Please consult the full Prescribing Information . 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 could benefit from HIV prevention. 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. References 1 Taiwo, B et al. VH3810109 (N6LS) Efficacy and Safety in Adults Who Are Virologically Suppressed: The EMBRACE Study. Presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2025), 9-12 March, San Francisco, CA SOURCE: ViiH Healthcare

Clinical ResultDrug ApprovalPhase 2Phase 3

12 Mar 2025

·firstwordpharma.com

ViiV to pursue six-month dosing for HIV antibody after positive Phase II readout

ViiV Healthcare, GSK's HIV-focused subsidiary, is pushing forward with a new long-acting treatment for patients with HIV. After positive results from a mid-stage study, the company says it will advance development of a six-month intravenous (IV) version of its experimental antibody-based therapy, N6LS (VH109), in combination with its long-acting HIV drug cabotegravir.The Phase IIb EMBRACE trial, presented Wednesday at the Conference on Retroviruses and Opportunistic Infections (CROI), showed that N6LS, given every four months along with monthly cabotegravir injections, successfully kept the virus under control in adults already stable on treatment.Primary endpoint data showed that after six months of treatment, 96% of patients given the IV formulation of N6LS maintained HIV-1 RNA levels below 50 copies/mL — exactly matching the success rate of current standard treatments. When given as a subcutaneous (SC) injection, 88% of patients maintained HIV-1 RNA levels below 50 copies/mL. Confirmed virologic failure was observed in two participants from each N6LS group.Meanwhile, the IV option stood out as better tolerated, with no infusion site reactions — unlike the SC group, where 14% of participants reported issues."We are building on the positive patient and physician experience we have with Cabenuva (cabotegravir/rilpivirine) and pioneering the next generation of long-acting treatment options," said Kimberly Smith, head of R&D at ViiV. Cabenuva was first approved by the FDA in 2021, with the product’s label updated the following year to include dosing every two months in virologically suppressed adults."We're looking forward to continuing the development of VH109 as a component of our future ultra long-acting regimens," Smith added.The N6LS presentation was part of a broader showcase of ViiV's long-acting portfolio at CROI, where the company also presented positive findings from two Phase IIa proof-of-concept trials. These additional studies evaluated VH184, a third-generation integrase inhibitor, and VH499, a capsid inhibitor.Specifically, ViiV said VH184 led to a "marked drop" in HIV-1 viral load across all tested doses — 10 mg, 50 mg, and 300 mg taken once every three days — during a 10-day monotherapy period, with the highest average viral load decline being -2.31 log10 copies/mL in the highest dose group. Similarly, VH499 showed decreases in HIV-1 viral load ranging from -1.8 to -2.2 log10 copies/mL across its dosing arms — 25 mg, 100 mg, and 250 mg — with the highest dose producing the greatest reduction.

Clinical ResultPhase 2Drug ApprovalPhase 3

03 Feb 2025

·www.pharmaceutical-technology.com

ViiV Healthcare and J&J’s adolescent HIV-1 combo gains EC authorisation

The combo was approved by the EMA in December 2020 for use in virologically suppressed adults with HIV-1. Credit: ktsdesign/Shutterstock. The European Commission (EC) has authorised the use of ViiV Healthcare’s Vocabria (cabotegravir long-acting injections) plus Rekambys (rilpivirine long-acting injections) from Johnson & Johnson (J&J) for treating adolescents with human immunodeficiency virus type-1 (HIV-1). The decision applies to individuals aged 12 and above, weighing a minimum of 35kg, who are virologically suppressed. ViiV Healthcare chief medical officer Harmony Garges stated: “This authorisation for Vocabria + Rekambys is an important milestone for adolescents living with HIV across Europe who may prefer a long-acting HIV treatment that could address challenges with taking daily oral regimens and could better suit their individual needs.” The authorisation is based on week 24 data from the ongoing Phase I/II trial, MOCHA, assessing the tolerability, pharmacokinetics and safety of the long-acting treatment combination. A virological suppression of 96.5% was maintained with no new safety concerns observed, according to data from 144 subjects in the trial. A significant majority – 99% of the study subjects – expressed a preference for the long-acting injectable treatment over daily oral medication. Reasons included convenience and a decrease in pill burden, which translates to less adherence-related stress and more privacy for the individuals. In December 2020, the combo was approved by the European Medicines Agency for use in virologically suppressed adults with HIV-1. Vocabria tablets should be in combination with rilpivirine tablets, and healthcare professionals are advised to consult the prescribing information for Edurant (rilpivirine) for proper dosing. The long-acting regimen minimises the number of doses required for HIV treatment, from 365 daily pills to as few as six injections per year. In October 2023, the National Medical Products Administration of China approved the use of Vocabria in conjunction with Rekambys for treating HIV-1 infection. A specialist HIV company, ViiV Healthcare is majority-owned by GSK while Shionogi and Pfizer are shareholders.

Drug ApprovalClinical StudyClinical ResultImmunotherapy

100 Deals associated with Rilpivirine Hydrochloride

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KEGG	Wiki	ATC	Drug Bank
D09720 D09958	Rilpivirine Hydrochloride	J05AG05	DB08864

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Indication	Country/Location	Organization	Date
HIV Infections	United States	Janssen Products LP	20 May 2011

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Indication	Highest Phase	Country/Location	Organization	Date
HIV Infections	Discovery	Puerto Rico	Janssen R&D Ireland Ltd.	01 May 2008
HIV Infections	Discovery	Puerto Rico	Janssen R&D Ireland Ltd.	01 May 2008
HIV Infections	Discovery	Taiwan Province	Janssen R&D Ireland Ltd.	01 May 2008
HIV Infections	Discovery	Thailand	Janssen R&D Ireland Ltd.	01 May 2008
HIV Infections	Discovery	Russia	Janssen R&D Ireland Ltd.	01 May 2008
HIV Infections	Discovery	Mexico	Janssen R&D Ireland Ltd.	01 May 2008
HIV Infections	Discovery	Russia	Janssen R&D Ireland Ltd.	01 May 2008
HIV Infections	Discovery	Mexico	Janssen R&D Ireland Ltd.	01 May 2008
HIV Infections	Discovery	Thailand	Janssen R&D Ireland Ltd.	01 May 2008
HIV Infections	Discovery	Taiwan Province	Janssen R&D Ireland Ltd.	01 May 2008

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03299049 \| NCT02951052 \| NCT02938520 (Pubmed \| J Infect Dis)	Phase 3	HIV Infections Maintenance	1,245	CAB + RPV LA every 4 week dosing	ovcjtitpce(iaijcjeier) = tggemdqlor kwjwgfrkuq (agdblkrbom )	Positive	25 Jul 2024
				CAB + RPV LA every 8 week dosing	ovcjtitpce(iaijcjeier) = nkomxsmrqv kwjwgfrkuq (agdblkrbom )
NCT00799864 (PAINT, CTgov)	Phase 2	HIV Infections	54	Rilpivirine (Cohort 1 Adolescents: Rilpivirine 25 mg)	wuhymyuwac(ljwxrdcpls) = eiyzyuzlor ecdpbmifok (nseyflzpbm, aaxpzcmroc - uzcqswfowc) View more	-	25 Jun 2024
				Rilpivirine (Cohort 2 Children (>=25 kg): Rilpivirine 25 mg)	wuhymyuwac(ljwxrdcpls) = ypnoukziov ecdpbmifok (nseyflzpbm, kmqczocphu - tkxxixcqlm) View more
NCT04012931 (CTgov)	Phase 2	HIV Infections	26	Rilpivirine (Rilpivirine 12.5 Milligrams (mg) (<20 kg))	jxonuftpxx(djcjwrhjie) = igludrbmha nptgkibjae (dzzdaoetsp, ibdorvqjdd - wfxflxznzp) View more	-	02 May 2024
				Rilpivirine (Rilpivirine 15 mg (<20 kg))	uacqsyuztj(uvsjaenfit) = cjzajbzqcf fjjhbrwnoc (vjevyizgzd, uvtkglnnfk - qovoqjticl) View more
NCT04399551 (CARISEL, CTgov)	Phase 3	HIV Infections	437	Continuous Quality Improvement (CQI) calls	kzpjaclean(yiepnhgnpb) = douhvyomia fwrrxzyplw (dwqbknljxx, fwigrfsbva - isqhwagbzv)	-	19 May 2023
NCT04399551 (CARISEL, Corporate Publications) Manual	Phase 3	HIV Infections	437	Cabotegravir+Rilpivirine Hydrochloride	kgtfmbvnfa(kxyarowykn) = jzytismkol mhifryhglv (nhdnspivsx ) View more	Positive	24 Oct 2022
NCT03639311 (Pubmed) Manual	Phase 2	HIV Infections	97	CAB+RPV long-acting	zqzzhhwvlj(cgfnhasqng) = evdhzmkata bykqzvynru (kmlphkomjg ) View more	Positive	01 Feb 2022
				dolutegravir/RPV	zqzzhhwvlj(cgfnhasqng) = wdulareove bykqzvynru (kmlphkomjg ) View more
NCT04001803 (CUSTOMIZE, CTgov)	Phase 3	HIV Infections	115	CAB+RPV LA (Staff Study Participants)	(bckjexgwuq) = gntdqufeae grotiwgdme (owxzxgzspn, fqhyaarchz - oihesqzybn) View more	-	10 Jan 2022
				long-acting (LA)+CAB LA+Rilpivirine (RPV) (Participants With HIV Infection)	tnacikjows(zrscbedjap) = ltcbomsemz xsuxwiccce (liqyjgmcux, swcenxxzli - galbgjnkpb) View more
CARLOS cohort (IAS2022)	Not Applicable	HIV Infections	236	Cabotegravir + Rilpivirine long acting	(tmzboxktla) = cyhfyqjzgb ezwffudrmt (xdotndanql ) View more	-	01 Jan 2022
IAS2022	Not Applicable	HIV Infections	70	CAB/RPV-LA	jmnnxemjrp(soywbstggc) = acokpugqof pglppwigaa (qldcctjygw ) View more	-	01 Jan 2022
IAS2022	Not Applicable	Maintenance	920	Long-acting cabotegravir+rilpivirine	xgpeeeneqg(qgdbneeigj) = qhhgqnqdnb ttzzlloxqv (shmwzhvrek ) View more	-	01 Jan 2022

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