Rodica Van Solingen‐Ristea

Janssen (Belgium)

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William Spreen

Triangle

Ronald D’Amico

GlaxoSmithKline (United States)

Susan L. Ford

Research Triangle Park Foundation

Herta Crauwels

Janssen (Belgium)

Kimberly Y. Smith

ViiV Healthcare (United Kingdom)

Parul Patel

Daiichi Sankyo (United States)

Kati Vandermeulen

Janssen (Belgium)

Simon Vanveggel

Janssen (Belgium)

Veerle Van Eygen

Janssen (Belgium)

David A. Margolis

Bioscience (China)

Cooperative Institutions

Janssen (Belgium)

Triangle

GlaxoSmithKline (United States)

ViiV Healthcare (United Kingdom)

Research Triangle Park Foundation

ViiV Healthcare (Spain)

Janssen (United States)

GlaxoSmithKline (United Kingdom)

GlaxoSmithKline (India)

Assistance Publique – Hôpitaux de Paris

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638. Safety, Efficacy, and Durability of Long-Acting CAB and RPV as Maintenance Therapy for HIV-1 Infection: LATTE-2 Week 256 Results

Open Forum Infectious Diseases (2020)

Graham Smith Keith Henry Daniel Podzamczer Mar Masiá Christopher Bettacchi

Abstract Background Long-acting (LA) injectable suspensions of cabotegravir (CAB) & rilpivirine (RPV) are in phase III development. LATTE-2 W160 results demonstrated high rates of virologic response & overall tolerability. This W256 analysis evaluated long-term efficacy, safety, & tolerability of every 8-week (Q8W) & 4-week (Q4W) intramuscular (IM) dosing. Methods LATTE-2 is a phase IIb, multicenter, parallel arm, open-label study in antiretroviral therapy–naive adults with HIV. After a 20-week Induction Period on oral CAB+abacavir/lamivudine, participants (pts) with plasma HIV-1 RNA< 50c/mL were randomized 2:2:1 to IM CAB LA+RPV LA Q8W, Q4W, or continue oral (PO) regimen in the Maintenance Period (MP). After W96, pts on IM regimens continued their current MP regimen. Pts randomized to PO in MP chose a Q8W or Q4W IM regimen in the Extension Period (EP). W256 analysis of MP & EP included virologic success with HIV-1 RNA< 50 c/mL (Food & Drug Administration Snapshot analysis), protocol-defined virologic failure (PDVF), & safety (intention-to-treat–Maintenance Exposed population). Results At W256, 88% (101/115; Q8W) & 74% (85/115; Q4W) of randomized IM pts had HIV-1 RNA< 50 c/mL, as did 93% (41/44) of PO to IM pts. No pt developed PDVF after W48. In the randomized IM arm (MP & EP), excluding injection-site reactions (ISRs), nasopharyngitis (45%), diarrhea (28%), & headache (24%) were the most common adverse events (AEs), with 34% (39/115; Q8W) & 33% (38/115; Q4W) of pts reporting AEs ≥grade 3, of which 12% (14/115; Q8W) & 11% (13/115; Q4W) were drug related. 3% (3/115; Q8W) & 17% (20/115; Q4W) of pts had AEs leading to withdrawal. 22% (25/115; Q8W) & 23% (27/115; Q4W) reported serious AEs (3 were drug related). In the PO to IM arm (EP only), most common AEs excluding ISRs were nasopharyngitis (25%), influenza (23%), & back pain (18%). 23% (10/44) reported AEs ≥grade 3 & 5% (2/44) had AEs leading to withdrawal. Majority of ISRs were mild/moderate pain & discomfort. < 1% of ISRs were severe, with 5 pts discontinuing due to ISRs. Table 1 Table 2 Conclusion CAB+RPV LA injectable therapy, administered Q8W or Q4W, demonstrated high rates of virologic response & tolerability through 5 years. W256 results add to previous results & demonstrate long-term durability of CAB+RPV LA for people living with HIV. Disclosures Keith Henry, MD, Gilead (Research Grant or Support, Paid to institution)GSK/ViiV (Research Grant or Support, Paid to institution)Janssen (Research Grant or Support, Paid to institution)Merck (Research Grant or Support, Paid to institution) Daniel Podzamczer, MD, PhD, Gilead (Grant/Research Support, Advisor or Review Panel member)Janssen Pharmaceutica (Grant/Research Support, Advisor or Review Panel member)Merck Sharp & Dohme (Grant/Research Support, Advisor or Review Panel member)ViiV Healthcare (Grant/Research Support, Advisor or Review Panel member) Mar Masiá, MD, PhD, Janssen Pharmaceutica (Consultant, Other Financial or Material Support, Travel/accommodations/meeting expenses)Merck Sharp & Dohme (Consultant, Other Financial or Material Support, Travel/accommodations/meeting expenses)ViiV Healthcare (Consultant, Other Financial or Material Support, Travel/accommodations/meeting expenses) Hans Jaeger, MD, Abbvie (Consultant, Speaker’s Bureau)Gilead Sciences (Consultant, Speaker’s Bureau)Janssen (Consultant, Speaker’s Bureau)MSD Sharp & Dohme (Consultant, Speaker’s Bureau)ViiV Healthcare (Consultant, Research Grant or Support, Speaker’s Bureau) Marie-Aude Khuong-Josses, MD, Viiv HC (Advisor or Review Panel member) Kenneth Sutton, MA, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) Cynthia C. McCoig, MD, ViiV Healthcare (Employee) Kati Vandermeulen, MSC, Janssen Pharmaceutica (Employee, Shareholder) Rodica Van Solingen-Ristea, MD, Janssen R&D (Employee) William Spreen, PharmD, ViiV Healthcare (Employee, Shareholder) David Margolis, MD, MPH, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee)

Tolerability

Regimen

Rilpivirine

Abacavir

10.1093/ofid/ofaa439.832

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Citations (2)

Pharmakokinetik des Proteaseinhibitors Telaprevir bei schwerer Niereninsuffizienz

Zeitschrift für Gastroenterologie (2011)

R. Van Heeswijk Ann Vandevoorde Griet Boogaerts Els De Paepe Rodica Van Solingen‐Ristea

Hintergrund/Ziele: Telaprevir (T) ist ein sich in der Entwicklung befindlicher HCV NS3·4A Proteaseinhibitor zur Behandlung der chronischen Hepatitis C Infektion in Kombination mit Peginterferon (P) und Ribavirin (R). T wird hauptsächlich über die Faeces ausgeschieden, bei minimaler renaler Exkretion. Schwere Niereninsuffizienz (NI) kann die extrarenale Elimination indirekt beeinflussen. Die Studie untersuchte den Einfluss von schwerer Niereninsuffizienz auf die Pharmakokinetik von T.

Telaprevir

10.1055/s-0031-1285682

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Citations (1)

Pharmacokinetics of Etravirine Combined with Atazanavir/Ritonavir and a Nucleoside Reverse Transcriptase Inhibitor in Antiretroviral Treatment-Experienced, HIV-1-Infected Patients

AIDS Research and Treatment (2015)

Catherine Orrell Franco Felizarta Andre S. Nell Thomas N. Kakuda Ludo Lavreys

Objectives. TEACH (NCT00896051) was a randomized, open-label, two-arm Phase II trial to investigate the pharmacokinetic interaction between etravirine and atazanavir/ritonavir and safety and efficacy in treatment-experienced, HIV-1-infected patients. Methods. After a two-week lead-in of two nucleoside reverse transcriptase inhibitors (NRTIs) and atazanavir/ritonavir 300/100 mg, 44 patients received etravirine 200 mg bid with one NRTI, plus atazanavir/ritonavir 300/100 mg or 400/100 mg qd (n = 22 each group) over 48 weeks. Results. At steady-state etravirine with atazanavir/ritonavir 300/100 mg qd or 400/100 mg qd decreased atazanavir C min⁡ by 18% and 9%, respectively, with no change in AUC24 h or C max⁡ versus atazanavir/ritonavir 300/100 mg qd alone (Day -1). Etravirine AUC12 h was 24% higher and 16% lower with atazanavir/ritonavir 300/100 or 400/100 mg qd, respectively, versus historical controls. At Week 48, no significant differences were seen between the atazanavir/ritonavir groups in discontinuations due to adverse events (9.1% each group) and other safety parameters, the proportion of patients with viral load <50 copies/mL (intent-to-treat population, noncompleter = failure) (50.0%, atazanavir/ritonavir 300/100 mg qd versus 45.5%, 400/100 mg qd), and virologic failures (31.8% versus 27.3%, resp.). Conclusions. Etravirine 200 mg bid can be combined with atazanavir/ritonavir 300/100 mg qd and an NRTI in HIV-1-infected, treatment-experienced patients without dose adjustment.

Atazanavir

Ritonavir

Etravirine

Reverse-transcriptase inhibitor

10.1155/2015/938628

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Citations (4)

Efficacy of telaprevir-based therapy in stable liver transplant patients with chronic genotype 1 hepatitis C.

DOAJ (DOAJ: Directory of Open Access Journals) (2016)

Xavier Forns Didier Samuel David Mutimer S. Fagiuoli Miquel Navasa

Telaprevir

Tolerability

Pegylated interferon

Regimen

Hepatitis C

Source

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Citations (4)

Long-Acting Cabotegravir and Rilpivirine Dosed Every 2 Months in Adults With Human Immunodeficiency Virus 1 Type 1 Infection: 152-Week Results From ATLAS-2M, a Randomized, Open-Label, Phase 3b, Noninferiority Study

Clinical Infectious Diseases (2023)

Edgar T. Overton Gary Richmond Giuliano Rizzardini Anders Thalme Pierre‐Marie Girard

Abstract Background Cabotegravir (CAB) + rilpivirine (RPV) dosed intramuscularly monthly or every 2 months is a complete, long-acting (LA) regimen for the maintenance of HIV-1 virologic suppression. Here, we report the antiretroviral therapy as long acting suppression (ATLAS)-2M study week 152 results. Methods ATLAS-2M is a phase 3b, randomized, multicenter study assessing the efficacy and safety of CAB+RPV LA every 8 weeks (Q8W) versus every 4 weeks (Q4W). Virologically suppressed (HIV-1 RNA <50 copies/mL) individuals were randomized to receive CAB+RPV LA Q8W or Q4W. Endpoints included the proportion of participants with plasma HIV-1 RNA ≥50 copies/mL and <50 copies/mL, incidence of confirmed virologic failure (CVF; 2 consecutive measurements ≥200 copies/mL), safety, and tolerability. Results A total of 1045 participants received CAB+RPV LA (Q8W, n = 522; Q4W, n = 523). CAB+RPV LA Q8W demonstrated noninferior efficacy versus Q4W dosing, with 2.7% (n = 14) and 1.0% (n = 5) of participants having HIV-1 RNA ≥50 copies/mL, respectively, with adjusted treatment difference being 1.7% (95% CI: 0.1–3.3%), meeting the 4% noninferiority threshold. At week 152, 87% of participants maintained HIV-1 RNA <50 copies/mL (Q8W, 87% [n = 456]; Q4W, 86% [n = 449]). Overall, 12 (2.3%) participants in the Q8W arm and 2 (0.4%) in the Q4W arm had CVF. Eight and 10 participants with CVF had treatment-emergent, resistance-associated mutations to RPV and integrase inhibitors, respectively. Safety profiles were comparable, with no new safety signals observed since week 48. Conclusions These data demonstrate virologic suppression durability with CAB+RPV LA Q8W or Q4W for ∼3 years and confirm long-term efficacy, safety, and tolerability of CAB+RPV LA as a complete regimen to maintain HIV-1 virologic suppression.

Rilpivirine

Tolerability

Regimen

10.1093/cid/ciad020

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Citations (57)

Tolérance de cabotégravir + rilpivirine pendant les phases d'instauration orale et de traitement à longue durée d'action : une analyse combinée de 3 études de Phase 3

Médecine et Maladies Infectieuses Formation (2022)

Laurent Finkielsztejn Patricio De los Rios‐Escalante Payal T. Patel J. Huang Ronald D’Amico

10.1016/j.mmifmc.2022.03.280

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Citations (0)

Pregnancy outcomes and pharmacokinetics in pregnant women living with HIV exposed to long‐acting cabotegravir and rilpivirine in clinical trials

HIV Medicine (2022)

Parul Patel Susan L. Ford Mark Baker Claudia Meyer Louise Garside

Abstract Background Limited data exist on pregnant women living with HIV exposed to cabotegravir + rilpivirine (CAB + RPV). Outcomes in pregnant participants exposed to CAB + RPV, and pharmacokinetic washout data in those exposed to CAB + RPV long‐acting (LA) with live births, are presented. Methods Women exposed to one or more doses of CAB + RPV (oral/LA) from ViiV Healthcare‐sponsored phase 2b/3/3b clinical trials and the compassionate use programme who became pregnant were included. Upon pregnancy in the trial programme, CAB + RPV was discontinued, an alternative antiretroviral regimen was initiated, and quarterly pharmacokinetic sampling for 52 weeks post‐last injection was obtained. CAB + RPV continuation or alternative antiretroviral regimen initiation was decided by pregnant compassionate use programme participants and their treating physicians. Results As of 31 March 2021, 25 pregnancies following CAB + RPV exposure at conception were reported (five oral, 20 LA), including four who conceived during pharmacokinetic washout following treatment discontinuation. There were eight elective abortions, six miscarriages (five in first trimester), one ectopic pregnancy, and 10 live births (one oral, nine LA), including one infant born with congenital ptosis. Among participants exposed to CAB + RPV LA at conception with live births, plasma CAB and RPV washout concentrations during pregnancy were within the range of those observed in non‐pregnant women. Conclusion In this first analysis of pregnancy outcomes following CAB + RPV exposure at conception, 10 live births, including one with congenital anomaly, were reported. Plasma CAB and RPV washout concentrations during pregnancy were within the range of those in non‐pregnant women. Pregnancy surveillance within ViiV Healthcare‐sponsored clinical trials is ongoing, with dedicated pregnancy studies planned.

Rilpivirine

Regimen

Discontinuation

Live birth

10.1111/hiv.13439

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Citations (34)

Efficacy, safety, and tolerability of switching to long-acting cabotegravir plus rilpivirine versus continuing fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide in virologically suppressed adults with HIV, 12-month results (SOLAR): a randomised, open-label, phase 3b, non-inferiority trial

The Lancet HIV (2023)

Moti Ramgopal Antonella Castagna Charles Cazanave Vicens Díaz-Brito Robin Dretler

Emtricitabine

Rilpivirine

Tenofovir alafenamide

Dolutegravir

Tolerability

10.1016/s2352-3018(23)00136-4

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Citations (42)

Pharmacokinetics of bound and unbound telaprevir in cirrhotic patients with moderate and severe hepatic impairment

The Journal of Clinical Pharmacology (2015)

Sivi Ouwerkerk‐Mahadevan Atef Halabi Blanka Cieslarová Indra Aerts James Witek

This study aimed to characterize the pharmacokinetic parameters of telaprevir (TVR) in patients with moderate and severe hepatic impairment, measure the unbound (pharmacologically active) plasma concentrations of TVR, and determine if any changes in TVR exposure were of clinical relevance. Ten patients with moderate (Child-Pugh B) hepatic impairment, 10 matched healthy control volunteers, and 4 nonmatched patients with severe (Child-Pugh C) hepatic impairment received 750 mg TVR every 8 hours for 6 days. Venous blood samples were collected at various times throughout the study. Single-dose and steady-state pharmacokinetics of total and unbound TVR were calculated. Safety and tolerability of TVR were also assessed. The mean maximum plasma concentration and area under the curve values of total and unbound TVR were lower in patients with moderate hepatic impairment compared with matched healthy controls following a single dose and at steady state but did not consistently meet statistical significance. This trend was also present when patients with severe hepatic impairment were compared with the nonmatched healthy controls. However, the safety profile of TVR in the patient and healthy volunteer groups was comparable with previously published data. These results indicate that reduced plasma concentrations of total and unbound TVR in patients with hepatic impairment are unlikely to be clinically relevant.

Tolerability

Clinical Significance

Volunteer

10.1002/jcph.545

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Citations (4)

Efficacy, Safety, and Pharmacokinetics by Body Mass Index Category in Phase 3/3b Long-Acting Cabotegravir Plus Rilpivirine Trials

The Journal of Infectious Diseases (2023)

Emilie R Elliot Joseph W. Polli Parul Patel Louise Garside Richard Grove

Cabotegravir + rilpivirine (CAB + RPV) is a guideline-recommended long-acting (LA) injectable regimen for the maintenance of HIV-1 virologic suppression. This post hoc analysis summarizes CAB + RPV LA results by baseline body mass index (BMI) category among Phase 3/3b trial participants.

Rilpivirine

10.1093/infdis/jiad580

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Citations (6)