People Living With MDR HIV-1

What may be possible for people living with MDR HIV‍-‍‍‍1?

For people living with multidrug-resistant (MDR) HIV-1, there may come a time when they need a change in regimen.¹

RUKOBIA is a first-in-class attachment inhibitor specifically developed for people living with MDR HIV-1.

Explore a range of people living with MDR HIV-1 who may benefit from RUKOBIA

ARV=antiretroviral; HIV-1=human immunodeficiency virus type-1.

The many faces of people living with MDR HIV-1^2-5

People living with MDR HIV-1 are a diverse group. Each has a unique journey but shares similar needs for:

Durable virologic suppression
CD4⁺ T-cell recovery
Well-tolerated ARV options with a manageable drug interaction profile

Images are not real patients. Profiles are adapted from BRIGHTE study participant characteristics.

65-year-old
Diagnosed 23 years ago

People living with MDR HIV-1 may be long-term survivors who are living with the prospect of running out of treatment options.

See the virologic suppression data for RUKOBIA

49-year-old
Diagnosed 20 years ago

People living with MDR HIV-1 may be concerned about ongoing viremia and the associated health risks. ^1,7-9

Review CD4⁺ T-cell recovery data for RUKOBIA

29-year-old
Diagnosed 15 years ago

People living with MDR HIV-1 may feel that they have to manage the side effects that come with their ARV options. ⁶

Explore RUKOBIA safety summary

59-year-old
Diagnosed 27 years ago

People living with MDR HIV-1 may need an ARV option with a different drug-drug interaction profile. ⁶

Review RUKOBIA
drug interactions

42-year-old
Diagnosed 20 years ago

People living with MDR HIV-1 may need another ARV option that works with their current oral dosing schedule.

See the dosing
schedule for RUKOBIA

Some people living with MDR HIV-1 are failing their current ARV regimen due to resistance, intolerance, or safety considerations and are in need of viable ARV options.¹ Hear the unique experiences and treatment journeys of these people living with HIV-1 (PLWH).

Stories of People Living With MDR HIV-1

James

Listen as James, a heavily treatment-experienced (HTE) patient living with HIV-1, discusses his experience beginning with accepting his diagnosis to now adhering to his treatment.

James, living with HIV. Individual results may vary.

Compensated by ViiV Healthcare.

DENNIS

Dennis shares his experience living with HIV and taking RUKOBIA as part of his HIV-1 treatment regimen.

Dennis, living with HIV and taking RUKOBIA. Individual results may vary.
Compensated by ViiV Healthcare.

References:

Ackerman P, Thompson M, Molina JM, et al. Long-term efficacy and safety of fostemsavir among subgroups of heavily treatment-experienced adults with HIV-1. AIDS. 2021;35(7):1061-1072.
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 September 21, 2022. Accessed November 7, 2022. https://clinicalinfo.hiv.gov/sites/default/files/
guidelines/documents/adultadolescent
-arv/guidelines-adult-adolescent-arv.pdf
European AIDS Clinical Society. Guidelines version 10.0: November 2019. Accessed February 1, 2020. https://www.eacsociety.org/files/
2019_guidelines-10.0_final.pdf
Henegar C, Vannappagari V, Viswanathan S, DeKoven M, Clark A, Ackerman P, et al. Identifying heavily treatment-experienced patients in a large administrative claims database. [Abstract MOPEB236] 10th IAS Conference on HIV Science (IAS); Mexico, City, Mexico, 21–24 July 2019.
Pelchen-Matthews A, Ryom L, Borges AH, Edwards S, Duvivier C, Stephan C, et al. Aging and the evolution of comorbidities among HIV-positive individuals in a European cohort. AIDS. 2018; 32:2405–2416.
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):740-751.
Pelchen-Matthews A, Borges AH, Reekie J, et al. Prevalence and outcomes for heavily treatment-experienced individuals living with human immunodeficiency virus in a European cohort. J Acquir Immune Defic Syndr. 2021;87(2):806-817.
Achhra A, Amin J, Law M, et al. Immunodeficiency and the risk of serious clinical endpoints in a well-studied cohort of treated HIV-infected patients. AIDS. 2010;24(12):1877-1886.
Engsig F, Zangerle R, Katsarou O, et al. Long-term mortality in HIV-positive individuals virally suppressed for >3 years with incomplete CD4 recovery. Clin Infect Dis. 2014;58(9):1312-1321.

References:

Ackerman P, Thompson M, Molina JM, et al. Long-term efficacy and safety of fostemsavir among subgroups of heavily treatment-experienced adults with HIV-1. AIDS. 2021;35(7):1061-1072.
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 September 21, 2022. Accessed November 7, 2022. https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/adultadolescent-arv/guidelines-adult-adolescent-arv.pdf
European AIDS Clinical Society. Guidelines version 10.0: November 2019. Accessed February 1, 2020. https://www.eacsociety.org/files/2019_guidelines-10.0_final.pdf
Henegar C, Vannappagari V, Viswanathan S, DeKoven M, Clark A, Ackerman P, et al. Identifying heavily treatment-experienced patients in a large administrative claims database. [Abstract MOPEB236] 10th IAS Conference on HIV Science (IAS); Mexico, City, Mexico, 21–24 July 2019.
Pelchen-Matthews A, Ryom L, Borges AH, Edwards S, Duvivier C, Stephan C, et al. Aging and the evolution of comorbidities among HIV-positive individuals in a European cohort. AIDS. 2018; 32:2405–2416.
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):740-751.
Pelchen-Matthews A, Borges AH, Reekie J, et al. Prevalence and outcomes for heavily treatment-experienced individuals living with human immunodeficiency virus in a European cohort. J Acquir Immune Defic Syndr. 2021;87(2):806-817.
Achhra A, Amin J, Law M, et al. Immunodeficiency and the risk of serious clinical endpoints in a well-studied cohort of treated HIV-infected patients. AIDS. 2010;24(12):1877-1886.
Engsig F, Zangerle R, Katsarou O, et al. Long-term mortality in HIV-positive individuals virally suppressed for >3 years with incomplete CD4 recovery. Clin Infect Dis. 2014;58(9):1312-1321.

FSTWCNT220030

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.

FSTWCNT220012

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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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 2023 Produced in USA.

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What may be possible for people living with MDR HIV‍-‍‍‍1?

Explore a range of people living with MDR HIV-1 who may benefit from RUKOBIA

The many faces of people living with MDR HIV-12-5

Stories of People Living With MDR HIV-1

The many faces of people living with MDR HIV-1^2-5