Transcript
VISUAL: CABENUVA and ViiV logos, series title and video title are on screen over Dr. Ramgopal and then move off screen.
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Expert Perspectives: Conversations on CABENUVA
SOLAR : A Head-To-Head Switch Study Of CABENUVA vs Continuing BIKTARVY
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Dr Ramgopal: Hello, my name is Dr Moti Ramgopal. I am a board-certified internal medicine and infectious disease doctor in Florida. Please join me for a discussion on the SOLAR clinical study, a head-to-head switch study of CABENUVA vs continuing daily oral BIKTARVY in which I served as an investigator. Before we begin, let us review some Important Safety Information for CABENUVA.
VISUAL: Speaker on frame; graphics animate on screen
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Speaker has been compensated by ViiV Healthcare
Moti Ramgopal, MD
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VO: CABENUVA is for virologically suppressed adults and adolescents with HIV-1 who meet certain requirements. See full indication on screen.
It is contraindicated in patients with a previous hypersensitivity reaction to cabotegravir or rilpivirine and in patients receiving the medications listed here.
Please watch the entire video for additional Important Safety Information.
Please click the link to view the Prescribing Information for CABENUVA.
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INDICATION
CABENUVA is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 35 kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
- Do not use CABENUVA in patients with previous hypersensitivity reaction to cabotegravir or rilpivirine
- Do not use CABENUVA in patients receiving carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, systemic dexamethasone (>1 dose), and St John’s wort
Please watch the entire video for additional Important Safety Information.
Please click the link to view the Prescribing Information for CABENUVA.
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Dr Ramgopal: I’m the founder and director of Midway Immunology Research Center in Fort Pierce, Florida, which in the last 15 years has been involved in over 300 clinical trials predominantly in HIV. I’m also the medical director of an organization of 15 clinics throughout Florida. Our patient population is an underserved community with a diverse multi-ethnic background.
Dr Ramgopal: Today’s presentation will cover patient perspectives of patients entering the SOLAR study. We’ll then go over the SOLAR study design and key efficacy and safety outcomes. Finally, we’ll discuss clinical considerations for CABENUVA and my approach to identifying appropriate patients.
VISUAL: Speaker on frame; split screen graphic animates on left-hand side; icons and content animate on screen as Dr. Ramgopal speaks.
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Today we’ll discuss:
- Patient Perspectives
- SOLAR Study Design and Outcomes
- Clinical Considerations for CABENUVA
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Dr Ramgopal: Let’s start our discussion with an overview of the patient perspective questionnaire at the beginning of SOLAR.
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SOLAR: Patient Perspectives
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Dr Ramgopal: The previous FLAIR, ATLAS, and ATLAS-2M trials all established the efficacy and safety of CABENUVA, which led to the approval of CABENUVA once-monthly and every-2-month dosing regimens.
Dr Ramgopal: Compared to the previous trials, SOLAR is the first and only study to date that compared switching to CABENUVA with continuing daily oral BIKTARVY. BIKTARVY was selected due to its common usage in patients living with HIV-1. The SOLAR study also evaluated the patient treatment preference as a secondary endpoint.
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SOLAR is the first head-to-head switch study comparing every-2-month CABENUVA with continuing daily oral BIKTARVY
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Dr Ramgopal: Patients who entered SOLAR were asked 3 baseline questions about their previous experience with taking daily oral therapy.
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Patients entering SOLAR on BIKTARVY revealed challenges with taking daily oral therapy at baseline
On Day 1 (exploratory endpoint), all patients entering SOLAR on BIKTARVY (n=670; mITT-E) responded to three baseline questions about their previous experience on a daily oral therapy
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Dr Ramgopal: 47% of the patients reported experiencing at least one of the following challenges, either always or often. They were worried about people unintentionally discovering their HIV status or they were worried about forgetting to take their HIV medication, or they felt that taking their HIV medication was an uncomfortable reminder of their HIV status.
VISUAL: Full-screen image; 47% circle graph and footnotes animate under content as Dr. Ramgopal speaks
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47% of patients in SOLAR reported experiencing at least one of the following challenges always or often:
- Worried about people unintentionally discovering their HIV status
- Worried about forgetting to take their HIV medication
- Felt that taking their HIV medication was an uncomfortable reminder of their HIV status
These results are descriptive in nature and should not be used to infer clinical significance.
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Dr Ramgopal: If you include those who sometimes agreed with at least one of the challenges, the percentage increased to 80%.
VISUAL: Full-screen image; 80% circle graph and footnotes animate under content as Dr. Ramgopal speaks
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80% of patients in SOLAR reported experiencing one of these same challenges always, often or sometimes:
- Worried about people unintentionally discovering their HIV status
- Worried about forgetting to take their HIV medication
- Felt that taking their HIV medication was an uncomfortable reminder of their HIV status
These results are descriptive in nature and should not be used to infer clinical significance.
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Dr Ramgopal: Now that we have reviewed some of the challenges that patients have experienced with taking daily oral therapy prior to the start of the SOLAR study, let’s dive into the study overview.
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SOLAR: Study Design
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Dr Ramgopal: The SOLAR study was a Phase 3b, open-label, noninferiority trial that compared switching to every-2-month CABENUVA with continuing once-daily BIKTARVY in virologically suppressed adult patients who were 18 years of age and older with HIV-1.
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SOLAR is the first head-to-head switch study comparing every-2-month CABENUVA with continuing daily oral BIKTARVY
A large phase 3b, open-label, noninferiority study of virologically suppressed adults (greater than or equal to 18 years) with HIV-1
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Dr Ramgopal: Patients came into the study virologically suppressed on BIKTARVY for at least 6 months and at screening.
VISUAL: Full-screen image; SOLAR study design and footnotes animate on screen as Dr. Ramgopal speaks
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Dr Ramgopal: Patients were randomized 2 to 1 either to switch to every-2-month CABENUVA, or to continue daily oral BIKTARVY. Patients that were randomized to CABENUVA were given the option of 1-month oral lead-in or to start long-acting intramuscular injections with CABENUVA directly.
VISUAL: Full-screen image; SOLAR study design and footnotes animate on screen as Dr. Ramgopal speaks
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Dr Ramgopal: The primary endpoint was the proportion of patients with HIV-1 RNA at least 50 copies per mL in the Month 12 analysis.
VISUAL: Full-screen image; SOLAR study design, primary endpoint graphic and footnotes animate on screen as Dr. Ramgopal speaks
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Dr Ramgopal: A key secondary endpoint was the proportion of patients with HIV-1 RNA with less than 50 copies per mL in the Month 12 analysis. Key exclusion criteria included history of virologic failure, known or suspected presence of resistance mutations to the individual components of BIKTARVY or CABENUVA, hepatitis B virus infection at screening, moderate to severe hepatic impairment, and women who were pregnant or breastfeeding or planned to become pregnant or breastfeed.
VISUAL: Full-screen image; SOLAR study design, primary endpoint and secondary efficacy endpoint graphics and footnotes animate on screen as Dr. Ramgopal speaks
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Dr Ramgopal: The efficacy analyses, baseline questionnaire, and preference calculation were based on the modified intent-to-treat population, mITT-E, which includes 670 patients. The safety analyses were based on the intent-to-treat population, ITT-E, where 681 patients were enrolled. The reason behind the modified intent-to-treat population is that 11 participants at a single study site were excluded from the ITT-E population due to significant and persistent non-compliance to protocol requirements.
VISUAL: Full-screen image; SOLAR study design, primary endpoint and secondary efficacy endpoint graphics, exclusion criteria graphic, associated bullets and footnotes animate on screen as Dr. Ramgopal speaks
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Dr Ramgopal: Now, let's jump into the baseline patient characteristics of the SOLAR study. When we look at the spectrum of patients in each treatment arm, I think it's important to recognize that SOLAR enrolled a broad range of patients. The median age of patients in the study was 37 years old, and about 20% of patients were age 50 or older. The majority of the patients were male, approximately 20% were female, and roughly 20% were Black or African American. In addition, patients were on treatment with BIKTARVY for almost 2 years prior to study enrollment.
VISUAL: Full-screen image; baseline patient characteristics table, associated bullets and footnotes animate on screen as Dr. Ramgopal speaks
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SOLAR included a broad range of patients
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Dr Ramgopal: Now that we have gone over the SOLAR study design, let’s review the main efficacy findings of the SOLAR study.
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SOLAR: Key Efficacy Results
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Dr Ramgopal: The SOLAR primary endpoint was met. Every-2-month CABENUVA was proven to be noninferior to BIKTARVY through the Month 12 analysis. Results from the key secondary endpoint demonstrated that rates of virologic suppression were also found to be similar between treatment arms.
VISUAL: Full-screen image; primary and secondary endpoint graphics and footnotes animate on screen as Dr. Ramgopal speaks
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SOLAR: Every-2-month CABENUVA was noninferior to daily oral therapy with BIKTARVY
FDA snapshot virologic outcomes through Month 12 analysis: every-2-month CABENUVA noninferior to BIKTARVY
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Dr Ramgopal: Confirmed virologic failure was observed in 2 patients receiving CABENUVA, representing 0.4% of patients in the mITT-E population. There was one additional patient on CABENUVA who developed CVF in the ITT-E population. All 3 of these patients were subsequently resuppressed on other alternative HIV medications. There were no confirmed virologic failures in the BIKTARVY group.
VISUAL: Full-screen image; Confirmed Virologic Failure through Month 12 Analysis graphic, associated bullets and footnotes animate on screen as Dr. Ramgopal speaks
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SOLAR: Confirmed virologic failures were seen in 2 patients receiving CABENUVA (in mITT-E)
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Dr Ramgopal: We also found that drug-related adverse events were more frequent in the CABENUVA arm. And this is not unexpected since this is a switch study, where patients had come into the study already virologically suppressed on BIKTARVY for almost 2 years. The most common drug-related adverse events in the CABENUVA arm were injection-site reactions which were identified in previous studies as well. Additionally, the patient discontinuation rate due to drug-related adverse events in the CABENUVA arm was 4%, of which 2% of CABENUVA patients discontinued treatment due to injection-related reasons.
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SOLAR: Safety Profile
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Dr Ramgopal: Now that we have gone over drug-related adverse events in the SOLAR study, let’s take a look at the incidence of injection-site reactions reported by visit. We can see by the figure that ISRs decreased over time. I think it is important to note that self-reported ISRs could potentially underestimate the true rate of ISRs over time. ISRs may still be present but not reported during the study. The majority of these ISR events were Grades 1-2, or mild to moderate in severity and occurred over a median of 3 days.
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SOLAR: Incidence of ISRs (All Grades) Reported by Visit
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Dr Ramgopal: At the Month 12 analysis or study withdrawal, CABENUVA-treated patients in the mITT-E population were asked to respond to a question about which regimen they preferred. 90% of the patients who responded to the survey preferred CABENUVA over daily oral therapy with BIKTARVY, 5% preferred BIKTARVY, and 5% had no preference. 22 patients did not respond to the survey.
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Every-2-month CABENUVA was preferred by 9 out of 10 survey respondents vs daily oral therapy with BIKTARVY
SOLAR: Survey Respondents’ Preference
- At the Month 12 analysis or study withdrawal (secondary endpoint), all CABENUVA treated patients in SOLAR (mITT-E; n=447) were asked to respond to a question about which regimen they preferred. 22 patients did not respond
- Respondents were asked to compare their experience using CABENUVA vs BIKTARVY, to select the treatment they preferred
These results are descriptive in nature and should not be used to infer clinical significance.
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Dr Ramgopal: The reasons for their preference were largely consistent with the challenges we observed with the baseline survey that was discussed earlier. The most common response was being worried about remembering to take their medication every day, followed by the convenience of every-2-month injections, not having to carry medication with them, not having to think about HIV status, and not having to worry about others seeing or finding their HIV pills.
VISUAL: Full-screen image; SOLAR Survey Respondent’s Preference table and footnotes animate on screen as Dr. Ramgopal speaks
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SOLAR: Survey Respondents’ Preference
CABENUVA-treated patients from SOLAR who preferred CABENUVA to BIKTARVY (n=382) were offered a list of responses to explain why
- The most commonly chosen responses were:
- 85%: “I do not have to worry as much about remembering to take HIV medication every day”
- 83%: “It is more convenient for me to receive injections every 2 months”
- 74%: “I do not have to carry my HIV medication with me”
- 61%: “I do not have to think about my HIV status every day”
- 59%: “I do not have to worry about others seeing or finding my HIV pills”
These results are descriptive in nature and should not be used to infer clinical significance.
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Dr Ramgopal: Now that we have gone through a summary of the study’s key findings, I want to talk about how the SOLAR study has not only impacted my clinical practice, but the treatment landscape as well.
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Clinical Considerations for CABENUVA
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Dr Ramgopal: A key question here is, what do physicians need to think about when moving forward with an injectable treatment option? While virologic suppression remains the most important goal of antiretroviral therapy, I think it’s also important that we consider what challenges patients might experience with their medicines.
Dr Ramgopal: I think providers need to start asking their patients questions such as, “do you hide your medication from those around you?”
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Potential Questions to Ask Your Patients Who May Be Struggling with Taking Daily Oral Therapy
- Do you hide your medication from those around you?
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Dr Ramgopal: Is it difficult to remember to take your oral treatment every day?
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- Is it difficult to remember to take your oral treatment every day?
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Dr Ramgopal: Do you feel that your HIV medication is an uncomfortable reminder of your HIV status? And once these questions are introduced to the patient, they have to think about the answer, even though they might have been taking their pills for some time. And that can reveal another element of patient care.
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- Do you feel that your HIV medication is an uncomfortable daily reminder of your HIV status?
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Dr Ramgopal: Even though a patient may seem comfortable with taking an oral medication and is virologically suppressed, this should not prevent providers from asking these types of questions. This is because taking an oral medication can be one of the many challenges that patients may already have, helping them alleviate even one challenge by offering CABENUVA as an alternative to daily oral treatment is very important to me.
As I've had these conversations, more and more patients have expressed interest in CABENUVA. I have patients who have been on CABENUVA for almost two years, and they are very comfortable receiving this medication. And I think my experience is reflective of what we saw in the SOLAR study in which 90% of the survey respondents preferred CABENUVA.
Dr Ramgopal: Additionally, providers may think that the initial startup to implement CABENUVA into their practice will be time-consuming. And while it does take some extra work to implement, I find that the end result is worth it once I see my patients looking forward to their next appointment for a CABENUVA treatment. Patients come into the clinic, get their CABENUVA injection, and then I check-in and monitor the patients before they leave. I have found that creating a system for CABENUVA implementation has been very helpful for my practice.
Dr Ramgopal: To summarize our conversation today, we discussed the challenges that patients may face with taking daily oral HIV therapy. We also reviewed that the SOLAR study is the first head-to-head switch study comparing every-2-month CABENUVA with continuing daily oral BIKTARVY.
The study found that every-two-month CABENUVA was noninferior to daily oral therapy with BIKTARVY. In addition, nine out of 10 survey respondents in the CABENUVA arm preferred CABENUVA over daily therapy with BIKTARVY.
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Today we discussed:
- Challenges to address
- Remove challenges of taking daily oral HIV therapy
- Proven efficacy
- Noninferior vs daily oral therapy with BIKTARVY
- Patient preference
- Preferred by 9 out of 10 survey respondents over daily oral therapy with BIKTARVY
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Dr Ramgopal: On behalf of ViiV Healthcare, I would like to thank you for taking the time to learn about the SOLAR study and how offering CABENUVA has impacted my clinical practice as well as the treatment landscape for HIV.
Continue watching for additional Important Safety Information.
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SUPER: Continue watching for additional Important Safety Information.
VO:
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions:
Serious or severe hypersensitivity reactions have been reported in association with other integrase inhibitors and during postmarketing experience with rilpivirine-containing regimens where reactions include cases of drug reaction with eosinophilia and systemic symptoms. Some skin reactions were accompanied by symptoms such as fever, other skin reactions were associated with organ dysfunctions.
Oral lead-in may be administered prior to administration of CABENUVA to help identify patients who may be at risk for a hypersensitivity reaction. If a hypersensitivity reaction is suspected, CABENUVA should be discontinued immediately, and the patient should be monitored.
Post-Injection Reactions:
In clinical trials, serious post-injection reactions, such as those shown here, were reported in less than 1% of subjects within minutes after the injection of rilpivirine. These events may have been a result of accidental IV administration and began to resolve within a few minutes after the injection.
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IMPORTANT SAFETY INFORMATION (continued)
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions:
- Serious or severe hypersensitivity reactions have been reported in association with other integrase inhibitors and could occur with CABENUVA
- Hypersensitivity reactions, including cases of drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during postmarketing experience with rilpivirine-containing regimens. While some skin reactions were accompanied by constitutional symptoms such as fever, other skin reactions were associated with organ dysfunctions, including elevations in hepatic serum biochemistries
- Discontinue CABENUVA immediately if signs or symptoms of hypersensitivity reactions develop. Clinical status, including liver transaminases, should be monitored and appropriate therapy initiated. Cabotegravir and rilpivirine oral lead-in may be used to help identify patients who may be at risk of a hypersensitivity reaction
Post-Injection Reactions:
- Serious post-injection reactions (reported in less than 1% of subjects) were reported within minutes after the injection of rilpivirine, including dyspnea, bronchospasm, agitation, abdominal cramping, rash/urticaria, dizziness, flushing, sweating, oral numbness, changes in blood pressure, and pain (e.g., back and chest). These events may have been associated with accidental intravenous administration and began to resolve within a few minutes after the injection
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VO: It is important to carefully follow the instructions for use and observe patients for approximately 10 minutes after the injection. If a post-injection reaction occurs, monitor and treat as clinically indicated.
Hepatotoxicity:
Hepatic adverse events have been reported in patients receiving cabotegravir or rilpivirine with or without pre-existing hepatic disease or identifiable risk factors. Patients with underlying liver disease prior to treatment may be at increased risk with CABENUVA. Hepatic monitoring is recommended and discontinue if hepatotoxicity is suspected.
Depressive Disorders:
Depressive disorders have been reported with CABENUVA or the individual components; promptly evaluate patients with depressive symptoms.
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IMPORTANT SAFETY INFORMATION (continued)
WARNINGS AND PRECAUTIONS (continued)
Post-Injection Reactions (continued):
- Carefully follow the Instructions for Use when preparing and administering CABENUVA. The suspensions should be injected slowly via intramuscular injection and avoid accidental intravenous administration. Observe patients briefly (approximately 10 minutes) after the injection. If a post-injection reaction occurs, monitor and treat as clinically indicated
Hepatotoxicity:
- Hepatotoxicity has been reported in patients receiving cabotegravir or rilpivirine with or without known pre-existing hepatic disease or identifiable risk factors
- Patients with underlying liver disease or marked elevations in transaminases prior to treatment may be at increased risk for worsening or development of transaminase elevations
- Monitoring of liver chemistries is recommended and treatment with CABENUVA should be discontinued if hepatotoxicity is suspected
Depressive Disorders:
- Depressive disorders (including depressed mood, depression, major depression, mood altered, mood swings, dysphoria, negative thoughts, suicidal ideation, suicide attempt) have been reported with CABENUVA or the individual products
- Promptly evaluate patients with depressive symptoms
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VO:
Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions:
Adverse reactions or loss of virologic response due to drug interactions with concomitant use of CABENUVA may occur. Use with caution in combination with drugs with a known risk of Torsade de Pointes.
Long-Acting Properties and Potential Associated Risks with CABENUVA:
Residual cabotegravir and rilpivirine concentrations may remain in the systemic circulation for up to 12 months or longer. Non-adherence to injections could lead to loss of virologic response and development of resistance. It is important to initiate a fully suppressive regimen no later than 1 month after the final injection doses of CABENUVA when dosed once-monthly and no later than 2 months after the final injections of CABENUVA when dosed every 2 months. If virologic failure is suspected, switch the patient to an alternative regimen as soon as possible.
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IMPORTANT SAFETY INFORMATION (continued)
WARNINGS AND PRECAUTIONS (continued)
Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions:
- The concomitant use of CABENUVA and other drugs may result in known or potentially significant drug interactions (see Contraindications and Drug Interactions)
- Rilpivirine doses 3 and 12 times higher than the recommended oral dosage can prolong the QTc interval
- CABENUVA should be used with caution in combination with drugs with a known risk of Torsade de Pointes
Long-Acting Properties and Potential Associated Risks with CABENUVA:
- Residual concentrations of cabotegravir and rilpivirine may remain in the systemic circulation of patients for prolonged periods (up to 12 months or longer). Select appropriate patients who agree to the required monthly or every-2-month injection dosing schedule because non-adherence could lead to loss of virologic response and development of resistance
- To minimize the potential risk of developing viral resistance, it is essential to initiate an alternative, fully suppressive antiretroviral regimen no later than 1 month after the final injection doses of CABENUVA when dosed monthly and no later than 2 months after the final injections of CABENUVA when dosed every 2 months. If virologic failure is suspected, switch the patient to an alternative regimen as soon as possible
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VO:
ADVERSE REACTIONS
The most common adverse drug reactions were injection site reactions, pyrexia, fatigue, headache, and those listed here. The safety of CABENUVA in adolescents is expected to be similar to adults.
DRUG INTERACTIONS
For important drug interaction information, refer to the full Prescribing Information for CABENUVA, VOCABRIA for oral cabotegravir, and EDURANT for oral rilpivirine. It is not recommended to coadminister CABENUVA with other antiretrovirals. Drugs that are strong inducers of UGT1A1 or UGT1A9 are expected to decrease the plasma concentrations of cabotegravir. Drugs that induce or inhibit CYP3A may affect the plasma concentrations of rilpivirine.
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IMPORTANT SAFETY INFORMATION (continued)
ADVERSE REACTIONS
- The most common adverse reactions in adults (incidence ≥2%, all grades) treated with CABENUVA were injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash
- The safety of CABENUVA in adolescents is expected to be similar to adults
DRUG INTERACTIONS
- Refer to the applicable full Prescribing Information for important drug interactions with CABENUVA, VOCABRIA (cabotegravir), or EDURANT (rilpivirine)
- Because CABENUVA is a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended
- Drugs that are strong inducers of UGT1A1 or UGT1A9 are expected to decrease the plasma concentrations of cabotegravir. Drugs that induce or inhibit CYP3A may affect the plasma concentrations of rilpivirine
- CABENUVA should be used with caution in combination with drugs with a known risk of Torsade de Pointes
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VO:
USE IN SPECIFIC POPULATIONS
Assess the potential risks of using CABENUVA during conception, pregnancy, and while breastfeeding.
Please click the link to view the Prescribing Information for CABENUVA.
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IMPORTANT SAFETY INFORMATION (continued)
USE IN SPECIFIC POPULATIONS
- Pregnancy: There are insufficient human data on the use of CABENUVA during pregnancy to adequately assess a drug-associated risk for birth defects and miscarriage. Discuss the benefit-risk of using CABENUVA during pregnancy and conception and consider that cabotegravir and rilpivirine are detected in systemic circulation for up to 12 months or longer after discontinuing injections of CABENUVA. An Antiretroviral Pregnancy Registry has been established
- Lactation: Potential risks of breastfeeding include HIV-1 transmission, developing viral resistance in HIV-positive infants, and adverse reactions in a breastfed infant
Please click the link to view the Prescribing Information for CABENUVA.
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Dr. Ramgopal: Are you interested in hearing more? Please watch the other videos in the series, “Expert Perspectives: Conversations on CABENUVA.”
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Expert Perspectives: Conversations on CABENUVA
Interested in hearing from more experts?
Check out our other videos in the “Expert Perspectives: Conversations on CABENUVA” series!
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