VO: Indication. RUKOBIA, used with other antiretrovirals, is indicated for heavily treatment-experienced adults with multidrug-resistant HIV-1 who are failing their current ARV regimen. 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 those listed here. Please see additional Important Safety Information for RUKOBIA at the end of the video. Please use the link on this page to view the full Prescribing Information for RUKOBIA.
VIDEO: Indication, ISI.
VO: My name is Dennis. I’m married and I live with my husband and our two dogs and a cat. I’m a heavily treatment-experienced person living with HIV.
VIDEO: B-Roll, Vineyard. Dennis walking toward the camera, his face obscured by the sun flare.
SUPER: The testimonial in this video is from a person living with HIV-1 sharing his personal experience about his diagnosis and his treatment with RUKOBIA. Individual results may vary.
VO: I was diagnosed with HIV in 1991. When I first received the diagnosis, I was upset. It was kind of a scary time. Back in those days, it was still very much something people thought you should be ashamed of.
VIDEO: B-Roll, Interview Camera A: Dennis taking an inhale, then releasing a deep exhale.
SUPER: Dennis, taking RUKOBIA as part of an HIV-1 regimen. Compensated by ViiV Healthcare.
VO: And I waited almost a year before I sought medical treatment. VIDEO: B-Roll, Interview Camera A.
VO: I think what was so difficult with adherence in the beginning is, um, I was still feeling a little bit of stigma. And also, the side effects were sometimes intolerable. I knew if could I take these pills, I’m gonna feel like I have a hangover all over again. So I wouldn’t.
VIDEO: Macro-shots of Dennis’ hands/gestures to express tension.
VO: I became, you know, serious and really consistent with treatment after I had a bout with toxoplasmosis in 1998.
VIDEO: Interview Footage—Camera B.
VO: My friend found me on the floor. I had passed out.
VIDEO: Screen quickly cuts to black.
VO: A couple days later is when I came to in the hospital.
VIDEO: Slowly fade in from black as “came to” VO plays; light peers through leaves in the wind.
VO: And that really, um, shook me. After I got out of the hospital I vowed I would never go back to that place again.
VIDEO: Interview Footage—Camera A.
VO: The minor challenges in the last, you know, I would say ten years, have always been when I started having treatment failure. And at times, you know, it was very frustrating because you’d be taking your meds, but you would still develop resistance. They would be kind of low points until I would talk to my doctor.
VIDEO: B-Roll, Tower Bridge: Dennis and Marcos shot from the front.
VO: We would just switch to, um, another regimen. And then 12 months, 14 months, 18 months in, we would start seeing virus again in the blood.
VIDEO: B-Roll, Tower Bridge: Dennis and Marcos pensively gazing into the distance, Dennis in focus.
VO: I have resistance to multiple classes of medication, but I’ve never given up. I’m always looking for the, that next thing that can help me.
VIDEO: Macro-shots of Dennis’ hands/gestures.
VO: The last regimen I was taking, I was starting to see more virus. The viral load had kept going up, and it was to the level where we didn’t want it. But I was thinking what am I gonna do?
VIDEO: B-Roll, Tower Bridge, Dennis in focus.
VO: My doctor said, “There’s a medication that’s in clinical trials.” Finding out that there was a medication like RUKOBIA. I had a great hope that this medication when added to others would help get me back down.
VIDEO: Interview Footage—Camera B. RUKOBIA logo appears on screen at first mention.
VO: So when I went into the study, the doctor at the study site was, uh, collaborating with other HIV experts around getting a regimen that would work for me and my multiple resistance.
VIDEO: Interview Footage—Camera A.
VO: RUKOBIA, in conjunction with the other antiretrovirals I’m taking, got me to undetectable.
VIDEO: B-Roll, Picnic: Dennis taking photographs.
SUPER: Not all patients who have taken RUKOBIA as part of an HIV-1 regimen reached undetectable.
VO: I have, uh, so many things to feel grateful for. I have a great support system around me and a husband who loves and supports me, um, and I can love and support back. I feel really confident. In the beginning, I wasn’t, and that’s natural. I’ve learned a few things, you can go on with the other things in your life that you want, and are meant, to do.
VIDEO: B-Roll Footage, Picnic, Vineyard.
VIDEO: Supporting data appears on screen.
SUPER/VO: BRIGHTE is a Phase 3, partially randomized trial in HTE patients with confirmed HIV-1 RNA greater than or equal to 400 copies per milliliter. The randomized cohort (double-blind, placebo-controlled through Day 8, then open-label through Week 96) enrolled 272 patients who had 1 or 2 ARV classes remaining due to resistance, intolerability, or contraindications.
The primary endpoint was based on the adjusted mean decline in HIV-1 RNA from Day 1 to Day 8 in the randomized cohort. RUKOBIA met the primary endpoint by achieving a statistically significant viral load reduction of 0.79 log10 compared to 0.17 log10 with placebo at Day 8.
As a secondary endpoint, BRIGHTE assessed the proportion of randomized patients who achieved virologic suppression with RUKOBIA + OBT, defined as a viral load of less than 40 copies per milliliter. At Week 96, 60% of patients achieved virologic suppression with RUKOBIA + OBT, an increase from 53% at Week 24. The FDA Snapshot Algorithm was used, in which patients who had missing HIV-1 RNA values or who changed the composition of their optimized background therapy were classified as having had virologic failure.
VO: The most common adverse reactions, all grades, observed in greater than or equal to 4% of patients in the randomized cohort were nausea, diarrhea, and headache.
VIDEO: AE Table fades on screen.
VO: Important Safety Information, continued. Warnings and Precautions. Immune Reconstitution Syndrome and autoimmune disorders have been reported with the use of RUKOBIA. QTc prolongation has occurred with higher than recommended dosages of RUKOBIA. Use RUKOBIA with caution in patients with a history of QTc interval prolongation or cardiac disease, or who are taking drugs with a known risk of Torsade de Pointes. Elderly patients may be more susceptible. Monitoring of liver chemistries is recommended in patients with hepatitis B and/or C co-infection. Diligence should be applied when starting RUKOBIA in patients receiving hepatitis B therapy. Adverse reactions or loss of virologic response due to drug interactions may occur when using RUKOBIA with other drugs. Adverse Reactions. The most common adverse reaction reported with RUKOBIA was nausea. Drug Interactions. See the full Prescribing Information for RUKOBIA for all significant drug interactions.
VIDEO: HCP Important Safety Information scrolls.
VO: 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 with careful monitoring. Patients receiving RUKOBIA should not take estrogen-based therapies that contain more than 30 micrograms per day of ethinyl estradiol.
Use RUKOBIA with caution in patients with additional risk factors for thromboembolic events. Use in Specific Populations. There are insufficient data on the use of RUKOBIA during pregnancy to assess drug-associated risks. Breastfeeding is not recommended in patients with HIV-1. Please use the link on this page to view the full Prescribing Information for RUKOBIA.
VIDEO: HCP Important Safety Information scrolls.
VIDEO: Reference block fades on screen.
VIDEO: RUKOBIA AND ViiV LOGOS.
SUPERS: Please use the link on this page to view the full Prescribing Information for RUKOBIA. Trademarks are owned by or licensed to the ViiV Healthcare group of companies. ©2021 ViiV Healthcare or licensor. FSTVID200016 April 2021 Produced in USA.
