Edge of Yesterday Podcast | RUKOBIA Official HCP Website

For heavily treatment-experienced adults with HIV-1 failing therapy. See Full Indication.

Edge of Yesterday, a podcast series, takes you on a journey from the early days of the AIDS epidemic up to the present day. Reflecting on the many milestones along the way reminds us of a subset of patients still in need. Each episode covers an important topic with firsthand accounts.

A WINDOW TO THE PAST

EPISODE 1

Two early pioneers in AIDS treatment and research, Dr. Michael Gottlieb and Marty St. Clair, talk about their involvement in the development and impact of early HIV-1 treatment. They will also discuss their points of view on RUKOBIA, an option for heavily treatment-experienced patients living with HIV-1.

Featured Guests

Dr. Gottlieb was responsible for describing the syndrome of opportunistic infections in CD4⁺ T-cell deficiency that characterized the condition that later became known as AIDS. Dr. Gottlieb also authored the first report of the syndrome to the Centers for Disease Control and Prevention, which was published on June 5, 1981, in Morbidity and Mortality Weekly Report, and would later write about a set of AIDS cases that were published in the New England Journal of Medicine.

Marty St. Clair, a virologist at ViiV Healthcare, has been working as a research scientist since the early 1980s. She was a part of the team that discovered and helped develop the first HIV drug, azidothymidine, otherwise known as AZT, or zidovudine.

To view references for “A Window to the Past,” click here.

EPISODE 2

Interview with Dr. Frank Spinelli, ViiV Healthcare's former U.S. Medical Director of Patient Affairs, and Dennis, who has been living with HIV-1 for three decades and is currently taking RUKOBIA as a part of his HIV-1 treatment regimen. Hear more about heavily treatment-experienced patients, what makes them unique, their treatment priorities, and the RUKOBIA BRIGHTE trial. The guests will also discuss their thoughts on RUKOBIA, an option for heavily treatment-experienced patients living with HIV-1.

FEATURED GUEST

Dennis, who is living with HIV-1 and taking RUKOBIA as a part of his HIV-1 treatment regimen, participated in the RUKOBIA BRIGHTE trial. He was diagnosed with HIV in 1991 and is considered a heavily treatment-experienced person living with HIV. In the early 2000s, Dennis started working in the field of HIV as a case manager.

To view references for “Who are Heavily Treatment-Experienced Patients, and What are Their Treatment Priorities?”, click here.

EPISODE 3

Interview with Dr. Peter Ackerman, former Physician Project Lead at ViiV Healthcare; and Dr. Cathy Creticos, a clinical investigator on the BRIGHTE trial. Hear more about heavily treatment-experienced patients living with HIV-1, the BRIGHTE Trial from the unique perspectives of the guests, and the drug development journey of fostemsavir, marketed as RUKOBIA. The guests will also discuss their thoughts on RUKOBIA, an option for heavily treatment-experienced patients living with HIV-1.

FEATURED GUEST

Dr. Cathy Creticos is an infectious disease specialist and practicing physician. She started working in HIV care in 1985 as a fellow in infectious disease when her site was selected to test azidothymidine, or AZT, the very first drug for HIV treatment. Since then, Dr. Creticos has been in private practice, taking care of patients living with HIV. In recent years, Dr. Creticos’ clinic was one of the sites selected to participate in the RUKOBIA BRIGHTE Trial.

To view references for “Discovering RUKOBIA, a Turning Point for Heavily Treatment-Experienced Patients,” click here.

References:

ViiV Healthcare. Treating HIV: Building On 30 Years of Innovation, Ingenuity and Passion. https://viivhealthcare.com/en-gb/our-stories/our-people/treating-hiv-building-on-30-years-of-innovation-ingenuity-and-passion/
Gottlieb MS. AIDS—past and future. N Engl J Med. 2001;344(23):1788-1791. doi: 10.1056/NEJM200106073442312
Centers for Disease Control and Prevention (CDC). AIDS: the Early Years and CDC’s Response. MMWR. 2011;60(04):64-69.
Fee E, Brown TM. Michael S. Gottlieb and the identification of AIDS. Am J Public Health. 2006;96(6):982-983. doi: 10.2105/AJPH.2006.088435
National Institute of Allergy and Infectious Diseases (NIAID). Antiretroviral Drug Discovery and Development. Accessed June 1, 2021. https://www.niaid.nih.gov/diseases-conditions/antiretroviral-drug-development
National Institutes of Health (NIH). In Their Own Words; NIH Researchers Recall the Early Years of AIDS. Discovery of HIV. Department of Health and Human Services. Accessed June 1, 2021. https://history.nih.gov/display/history/Discovery+of+HIV
Shampo MA, Kyle RA. Luc Montagnier—discoverer of the AIDS virus. Mayo Clin Proc. 2002;77(6):506. doi: 10.4065/77.6.506
Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV. Department of Health and Human Services. Updated May 26, 2020. Accessed June 1, 2020 https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/adult-adolescent-oi/guidelines-adult-adolescent-oi.pdf
Deeks SG, Overbaugh J, Phillips A, Buchbinder S. HIV infection. Nat Rev Dis Primers. 2015;1(15035):1-22. doi: 10.1038/nrdp.2015.35
National Institutes of Health (NIH). In Their Own Words; NIH Researchers Recall the Early Years of AIDS. First Encounters. Department of Health and Human Services. Accessed June 1, 2021. https://history.nih.gov/display/history/First+Encounters
Centers for Disease Control and Prevention (CDC). Pneumocystis Pneumonia—Los Angeles. MMWR. 1981;30(21):1-3.
Quinn TC. HIV epidemiology and the effects of antiviral therapy on long-term consequences. AIDS. 2008;Suppl 3(Suppl 3):S7-S12. doi: 10.1097/01.aids.0000327510.68503.e8
Cochrane J. Zidovudine’s patent history. The Lancet. 2000;356(9241):1611-1612. Accessed June 1, 2021. https://www.thelancet.com/action/showPdf?pii=S0140-6736%2805%2974463-9
McHugh J. A tap and drain: sinking CD4⁺ T cells. Nature Milestones. Accessed June 16, 2021. https://media.nature.com/original/magazine-assets/d42859-018-00014-8/d42859-018-00014-8.pdf
Lataillade M, Lalezari JP, Kozal M, et al. Safety and efficacy of the HIV-1 attachment inhibitor prodrug fostemsavir in heavily treatment-experienced individuals: week 96 results of the phase 3 BRIGHTE study. Lancet HIV. 2020;7(11):e740-e751. doi: 10.1016/S2352-3018(20)30240-X
Data on file, ViiV Healthcare.
Cutrell J, Jodlowski T, Bedimo R. The management of treatment-experienced HIV patients (including virologic failure and switches). Ther Adv Infectious Dis. 2020(7):1-15. doi: 10.1177/2049936120901395
Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in adults and adolescents with HIV. Department of Health and Human Services. Updated June 3, 2021. Accessed June 1, 2021. https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/AdultandAdolescentGL.pdf

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ARROW

IMPORTANT
SAFETY INFORMATION

Contraindications

Do not use in patients with previous hypersensitivity to fostemsavir or any of the components of RUKOBIA.

Do not use RUKOBIA in patients receiving strong cytochrome P450 (CYP)3A inducers, including but not limited to enzalutamide, carbamazepine, phenytoin, rifampin, mitotane, and St John’s wort (Hypericum perforatum).

Warnings and precautions

Immune Reconstitution Syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported with the use of RUKOBIA.

QTc Prolongation with Higher than Recommended Dosages: RUKOBIA at 2,400 mg twice daily has been shown to significantly prolong the QTc interval of the electrocardiogram. Use RUKOBIA with caution in patients with a history of QTc interval prolongation or in patients with relevant pre-existing cardiac disease or who are taking drugs with a known risk of Torsade de Pointes. Elderly patients may be more susceptible to drug-induced QT interval prolongation.

Elevations in Hepatic Transaminases in Patients with Hepatitis B or C Virus Co-infection:

Monitoring of liver chemistries is recommended in patients with hepatitis B and/or C co-infection.

Diligence should be applied in initiating or maintaining effective hepatitis B therapy when starting RUKOBIA in patients co-infected with hepatitis B.

Adverse Reactions or Loss of Virologic Response Due to Drug Interactions with concomitant use of RUKOBIA and other drugs may occur (see Contraindications and Drug Interactions).

Adverse reactions

The most common adverse reaction (all grades, randomized cohort) observed in ≥5% of subjects was nausea (10%).

81% of adverse reactions reported with RUKOBIA were mild or moderate in severity.

Drug interactions

See the full Prescribing Information for RUKOBIA for a complete list of significant drug interactions.

Temsavir may increase plasma concentrations of grazoprevir and voxilaprevir. Use an alternative hepatitis C virus regimen if possible.

Use the lowest possible starting dose for statins and monitor for statin-associated adverse events.

Patients receiving RUKOBIA should not take doses of estrogen-based therapies, including oral contraceptives, that contain more than 30 mcg/day of ethinyl estradiol. Caution is advised particularly in patients with additional risk factors for thromboembolic events.

Use in specific populations

Pregnancy: There are insufficient human data on the use of RUKOBIA during pregnancy to definitively assess a drug-associated risk for birth defects and miscarriage. An Antiretroviral Pregnancy Registry has been established.

Lactation: Breastfeeding is not recommended due to the potential for HIV-1 transmission, developing viral resistance, and adverse reactions in a breastfed infant.

INDICATION

RUKOBIA, in combination with other antiretrovirals (ARVs), is indicated to treat HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current ARV regimen due to resistance, intolerance, or safety considerations.

Please see full Prescribing Information for RUKOBIA.

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To report SUSPECTED ADVERSE REACTIONS, contact ViiV Healthcare at
1-877-844-8872 or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.

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This site is intended for US healthcare professionals only.

Trademarks are owned by or licensed to the

ViiV Healthcare group of companies.

This site is funded and developed by

ViiV Healthcare.

This site is intended for US healthcare

professionals only.

June 2022 Produced in USA.

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