ViiV HEALTHCARE TO SHOWCASE INNOVATIVE HIV TREATMENT AND PREVENTION PORTFOLIO AT IDWEEKTM AND HIV GLASGOW
More than 50 abstracts at the two scientific congresses will showcase new mechanisms of action, implementation of the only complete long-acting treatment regimen and key insights into real-world treatment outcomes
*Rapid-Fire Poster indicates mini oral session
|Abstract Title||First Author||Presentation|
|Durable Efficacy of Switching from a 3-/4-Drug Tenofovir Alafenamide (TAF)-Based Regimen to the 2-Drug Regimen Dolutegravir/Lamivudine (DTG/3TC) in the TANGO Study Through Week 196||S. De Wit
|Risk of Tuberculosis After Initiation of Antiretroviral Therapy Among People Living with HIV in Europe||I. S. Johansen
|Efficacy and Safety of Dolutegravir/Lamivudine (DTG/3TC) in Black and Asian Participants from TANGO and SALSA: Pooled 48-Week Data Analyzed by Race||P. Kumar||Poster|
|Patient-Reported Symptom Outcomes Following DTG/3TC Use in a Test and Treat Setting: Results from the STAT Study||A. Oglesby||Poster
|High Efficacy of Dolutegravir/Lamivudine (DTG/3TC) in Treatment-Naive Adults with HIV-1 and High Baseline Viral Load (VL): 48-Week Subgroup Analyses of the GEMINI-1/-2 and STAT Trials||C. Rolle||Poster|
|Efficacy and Safety of Switching to Dolutegravir Plus Rilpivirine in Virologically Suppressed Older PLWH: Pooled Week 148 Results from SWORD-1 and SWORD-2||M. Prakash||Poster|
|Systematic Literature Review of Real-World Experience with the 2-Drug Regimen Dolutegravir and Lamivudine in People with HIV Who Would Not Have Met Inclusion Criteria for the Phase 3 Clinical Program (Encore)||J. Slim||Poster|
|Real-World Experience with the 2-Drug Regimen Dolutegravir and Lamivudine in Women with HIV: A Systematic Literature Review||S. di Giambenedetto||Poster|
|Lipid Changes in Real-World Studies with the 2-Drug Regimen Dolutegravir and Lamivudine (DTG + 3TC) in People with HIV-1: A Systematic Literature Review||E. Letang||Poster|
|Effectiveness of Dolutegravir + Lamivudine in Real-World Studies in People with HIV-1 with M184V/I Mutations:
A Systematic Review and Meta-Analysis
|Treatment-Emergent Integrase Inhibitor Resistance Among Pediatric and Adolescent HIV-1 Populations: A Systematic Review||C. Henegar||Poster|
|Initial Plasma HIV-1 RNA and CD4+ T-Cell Count Are Determinants of Virological Outcomes with Initial Integrase Inhibitor-Based Regimens: A Prospective Multinational RESPOND Cohort Consortium||H. Álvarez||Poster|
|2 Year Outcomes of Dolutegravir (DTG) + Lamivudine (3TC) in ART-Naive and Pre-Treated People Living with HIV in Germany: Real-World Data from the German URBAN Cohort||D. Beer||Poster|
|3-Year Outcomes of Dolutegravir/Rilpivirine in Virologically Suppressed PLHIV: Real-World Data from the Prospective German JUNGLE Cohort||F. Schabaz||Poster|
|Use of Preventive Measures for Cardiovascular Disease in People Living with HIV||N. Jaschinski||Poster|
|Real World Use of Dolutegravir/Lamivudine in Treatment Naive People Living with HIV During the COVID Pandemic||G. Pierone||Poster|
|Real-World Data from the Prospective, Multicenter Study on the Use of Dolutegravir-Based Regimens (DBRs) in ART-Naive and Experienced People Living with HIV: 12-Months Results from the Russian TESLA Study||S. Kuznetsov||Poster|
|Cabotegravir for Treatment|
|Expanded Multivariable Models to Assist Patient Selection for Long-Acting Cabotegravir+Rilpivirine Treatment: Clinical Utility of a Combination of Patient, Drug Concentration, and Viral Factors Associated with Virologic Failure Over 152 Weeks||C. Orkin||Oral|
|6-Month Outcomes of Every 2-Months Long-Acting Cabotegravir and Rilpivirine in a Real-World Setting – Effectiveness, Adherence to Injections and Patient Reported Outcomes from PLHIV in the German CARLOS Cohort||J. Borch||Oral|
|HIV-1 RNA Blips, Low-Level Viral Replication and Mean CD4+/CD8+ Ratio During Phase 3 Cabotegravir + Rilpivirine Long-Acting Study (FLAIR) are Similar to Oral 3-Drug Therapy Through Week 96||C. Latham||Poster|
|Patient-Reported Outcomes After 152 Weeks of HIV Maintenance Therapy with Long-Acting Cabotegravir + Rilpivirine in the Phase 3b ATLAS-2M Study||V. Chounta||Poster|
|Drug-Related Neuropsychiatric Adverse Events Across Phase 3/3b Studies of Long-Acting Cabotegravir + Rilpivirine Through Week 48||E. Elliot||Poster|
|The Implementation of Every 2-Months Cabotegravir and Rilpivirine Long-Acting Injections from the Perspective of Healthcare Providers in the German CARLOS Cohort, 6-Month Outcomes||J. Scherzer||Poster|
|Perceptions of Cabotegravir and Rilpivirine Long-Acting (CAB+RPV LA) from Patients in the CAB+RPV Implementation Study in European Locations (CARISEL)||T. Lutz||Poster|
|Overcoming Barriers and Achieving Optimal Implementation of Cabotegravir and Rilpivirine Long-Acting (CAB+RPV LA): Staff Study Participant (SSP) Results from the CAB+RPV Implementation Study in European Locations (CARISEL)||L. Slama||Poster|
|Implementation of Cabotegravir and Rilpivirine Long-Acting (CAB+RPV LA): Primary Results from the CAB+RPV Implementation Study in European Locations (CARISEL)||B. J. van Welzen||Poster|
|Cabotegravir for PrEP Collaborative Study|
|Laboratory analysis of HIV infections in the Year 1 unblinded period of HPTN 083: injectable cabotegravir for PrEP in MSM and TGW||M. A. Marzinke||Oral|
|Efficacy and Safety of Fostemsavir Plus Optimised Background Therapy in Heavily Treatment-Experienced Adults with HIV-1: Week 240 Results of the Phase 3 BRIGHTE Study (encore)||J. Aberg||Poster|
|A Multivariable Analysis of the Phase 3 BRIGHTE Trial, Through Week 24, to Identify Predictors of Virologic Response to Fostemsavir in Heavily Treatment-Experienced People Living with HIV||M. Gartland||Poster|
|Fostemsavir and QT Prolongation: Clinical Applications for Co-Administration with Other Agents||S. Patel||Poster|
|Maturation Inhibitor GSK 3640254|
|Effects of the HIV-1 Maturation Inhibitor GSK3640254 on QT Interval in Healthy Participants||Y. Zhang||Poster|
|VH3810109 (N6LS) Reduces Viremia Across a Range of Doses in ART-Naive Adults Living with HIV: Proof of Concept Achieved in the Phase IIa BANNER (207959, NCT04871113) Study||P. Leone||Oral|
|Age Related Differences in Quality of Life Outcomes of People Living with HIV||A. Clark||Poster|
APRETUDE (cabotegravir) extended-release injectable suspensions
APRETUDE is indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test prior to initiating APRETUDE (with or without an oral lead-in with oral cabotegravir) for HIV-1 PrEP.
IMPORTANT SAFETY INFORMATION
BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF APRETUDE FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTION
Individuals must be tested for HIV-1 infection prior to initiating APRETUDE or oral cabotegravir, and with each subsequent injection of APRETUDE, using a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection. Drug-resistant HIV-1 variants have been identified with use of APRETUDE by individuals with undiagnosed HIV-1 infection. Do not initiate APRETUDE for HIV-1 PrEP unless negative infection status is confirmed. Individuals who become infected with HIV-1 while receiving APRETUDE for PrEP must transition to a complete HIV-1 treatment regimen.
- Do not use APRETUDE in individuals:
- with unknown or positive HIV-1 status
- with previous hypersensitivity reaction to cabotegravir
- receiving carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, and rifapentine
WARNINGS AND PRECAUTIONS
Comprehensive Management to Reduce the Risk of HIV-1 Infection:
- Use APRETUDE as part of a comprehensive prevention strategy, including adherence to the administration schedule and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs). APRETUDE is not always effective in preventing HIV-1 acquisition. Risk for HIV-1 acquisition includes, but is not limited to, condomless sex, past or current STIs, self-identified HIV risk, having sexual partners of unknown HIV-1 viremic status, or sexual activity in a high prevalence area or network. Inform, counsel, and support individuals on the use of other prevention measures (e.g., consistent and correct condom use; knowledge of partner[s] HIV-1 status, including viral suppression status; regular testing for STIs)
- Use APRETUDE only in individuals confirmed to be HIV-1 negative. HIV-1 resistance substitutions may emerge in individuals with undiagnosed HIV-1 infection who are taking only APRETUDE, because APRETUDE alone does not constitute a complete regimen for HIV-1 treatment. Prior to initiating APRETUDE, ask seronegative individuals about recent (in past month) potential exposure events and evaluate for current or recent signs or symptoms consistent with acute HIV-1 infection (e.g., fever, fatigue, myalgia, skin rash). If recent (<1 month) exposures to HIV-1 are suspected or clinical symptoms consistent with acute HIV-1 infection are present, use a test approved or cleared by the FDA as an aid in the diagnosis of acute HIV-1 infection
- When using APRETUDE, HIV-1 testing should be repeated prior to each injection and upon diagnosis of any other STIs
- Additional HIV testing to determine HIV status is needed if an HIV-1 test indicates possible HIV-1 infection or if symptoms consistent with acute HIV-1 infection develop following an exposure event. If HIV-1 infection is confirmed, then transition the individual to a complete HIV-1 treatment
- Counsel HIV-1 uninfected individuals to strictly adhere to the recommended dosing and testing schedule for APRETUDE
Potential Risk of Resistance with APRETUDE:
- There is a potential risk of developing resistance to APRETUDE if an individual acquires HIV-1 either before, while taking, or following discontinuation of APRETUDE. To minimize this risk, it is essential to clinically reassess individuals for risk of HIV-1 acquisition and to test before each injection to confirm HIV-1–negative status. Individuals who are confirmed to have HIV-1 infection must transition to a complete HIV-1 treatment. If individuals at continuing risk of HIV-1 acquisition discontinue APRETUDE, alternative forms of PrEP should be considered and initiated within 2 months of the final injection of APRETUDE
Long-Acting Properties and Potential Associated Risks with APRETUDE:
- Residual concentrations of cabotegravir may remain in the systemic circulation of individuals for prolonged periods (up to 12 months or longer). Take the prolonged-release characteristics of cabotegravir into consideration and carefully select individuals who agree to the required every-2-month injection dosing schedule because non-adherence or missed doses could lead to HIV-1 acquisition and development of resistance
- Serious or severe hypersensitivity reactions have been reported in association with other integrase inhibitors and could occur with APRETUDE
- Discontinue APRETUDE immediately if signs or symptoms of hypersensitivity reactions develop. Clinical status, including liver transaminases, should be monitored and appropriate therapy initiated
- Hepatotoxicity has been reported in a limited number of individuals receiving cabotegravir with or without known pre-existing hepatic disease or identifiable risk factors
- Clinical and laboratory monitoring should be considered and APRETUDE should be discontinued if hepatotoxicity is suspected and individuals managed as clinically indicated
- Depressive disorders (including depression, depressed mood, major depression, persistent depressive disorder, suicidal ideation or attempt) have been reported with APRETUDE
- Promptly evaluate patients with depressive symptoms
Risk of Reduced Drug Concentration of APRETUDE Due to Drug Interactions:
- The concomitant use of APRETUDE and other drugs may result in reduced drug concentration of APRETUDE
- Refer to the full Prescribing Information for steps to prevent or manage these possible and known significant drug interactions, including dosing recommendations. Consider the potential for drug interactions prior to and during use of, and after discontinuation of APRETUDE; review concomitant medications during use of APRETUDE
The most common adverse reactions (incidence ≥1%, all grades) with APRETUDE were injection site reactions, diarrhea, headache, pyrexia, fatigue, sleep disorders, nausea, dizziness, flatulence, abdominal pain, vomiting, myalgia, rash, decreased appetite, somnolence, back pain, and upper respiratory tract infection.
- Refer to the full Prescribing Information for important drug interactions with APRETUDE
- Drugs that induce UGT1A1 may significantly decrease the plasma concentrations of cabotegravir
USE IN SPECIFIC POPULATIONS
- Lactation: Assess the benefit-risk of using APRETUDE to the infant while breastfeeding due to the potential for adverse reactions and residual concentrations in the systemic circulation for up to 12 months or longer after discontinuation
- Pediatrics: Not recommended in individuals weighing less than 35 kg
Please see full Prescribing Information for APRETUDE.
Important Safety Information for Dovato (50mg dolutegravir/300mg lamivudine) Tablets
Dovato is indicated as a complete regimen to treat HIV-1 infection in adults with no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable ARV regimen with no history of treatment failure and no known resistance to any component of Dovato.
IMPORTANT SAFETY INFORMATION
BOXED WARNING: PATIENTS CO-INFECTED WITH HEPATITIS B VIRUS (HBV) AND HIV-1: EMERGENCE OF LAMIVUDINE-RESISTANT HBV AND EXACERBATIONS OF HBV
All patients with HIV-1 should be tested for the presence of HBV prior to or when initiating Dovato. Emergence of lamivudine-resistant HBV variants associated with lamivudine-containing antiretroviral regimens has been reported. If Dovato is used in patients co-infected with HIV-1 and HBV, additional treatment should be considered for appropriate treatment of chronic HBV; otherwise, consider an alternative regimen.
Severe acute exacerbations of HBV have been reported in patients who are co-infected with HIV-1 and HBV and have discontinued lamivudine, a component of Dovato. Closely monitor hepatic function in these patients and, if appropriate, initiate anti-HBV treatment.
- Do not use Dovato in patients with previous hypersensitivity reaction to dolutegravir or lamivudine
- Do not use Dovato in patients receiving dofetilide
Warnings and precautions
- Hypersensitivity reactions have been reported with dolutegravir and were characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury
- Discontinue Dovato immediately if signs or symptoms of severe skin or hypersensitivity reactions develop, as a delay in stopping treatment may result in a life-threatening reaction. Clinical status, including liver aminotransferases, should be monitored and appropriate therapy initiated
- Hepatic adverse events have been reported, including cases of hepatic toxicity (elevated serum liver biochemistries, hepatitis, and acute liver failure), in patients receiving a dolutegravir-containing regimen without pre-existing hepatic disease or other identifiable risk factors
- Patients with underlying hepatitis B or C or marked elevations in transaminases prior to treatment may be at increased risk for worsening or development of transaminase elevations with use of Dovato. In some cases, the elevations in transaminases were consistent with immune reconstitution syndrome or hepatitis B reactivation, particularly in the setting where anti-hepatitis therapy was withdrawn
- Monitoring for hepatotoxicity is recommended
Embryo Fetal Toxicity:
- Assess the risks and benefits of Dovato and discuss with the patient to determine if an alternative treatment should be considered at the time of conception through the first trimester of pregnancy due to the risk of neural tube defects
- Pregnancy testing is recommended before initiation of Dovato. Individuals of childbearing potential should be counselled on the consistent use of effective contraception
Lactic Acidosis and Severe Hepatomegaly with Steatosis:
Fatal cases have been reported with the use of nucleoside analogues, including lamivudine. Discontinue Dovato if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations.
Adverse Reactions or Loss of Virologic Response Due to Drug Interactions with concomitant use of Dovato and other drugs may occur (see Contraindications and Drug interactions).
Immune Reconstitution Syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported with the use of Dovato.
The most common adverse reactions (incidence ≥2%, all grades) with Dovato were headache (3%), nausea (2%), diarrhoea (2%), insomnia (2%), fatigue (2%), and anxiety (2%).
- Consult full Prescribing Information for Dovato for more information on potentially significant drug interactions
- Dovato is a complete regimen. Coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended
- Drugs that induce or inhibit CYP3A or UGT1A1 may affect the plasma concentrations of dolutegravir
- Administer Dovato 2 hours before or 6 hours after taking polyvalent cation-containing antacids or laxatives, sucralfate, oral supplements containing iron or calcium, or buffered medications. Alternatively, Dovato and supplements containing calcium or iron can be taken with food
Use in specific populations
- Pregnancy: The safety and efficacy of a dual regimen has not been studied in pregnancy. If a pregnancy is confirmed in the first trimester while on Dovato, the benefits and risks of continuing Dovato versus switching to another antiretroviral regimen should be discussed with the patient taking the gestational age and the critical time period of neural tube defect development into account. Data analysed from the Antiretroviral Pregnancy Registry do not indicate an increased risk of major birth defects in women exposed to dolutegravir during pregnancy but are currently insufficient to address the risk of neural tube defects. Dovato may be used during the second and third trimester of pregnancy when the expected benefit justifies the potential risk to the foetus.
- Lactation: Breastfeeding is not recommended due to the potential for HIV-1 transmission.
- Women of childbearing potential (WOCBP): WOCBP should be counselled about the potential risk of neural tube defects with dolutegravir (a component of Dovato), including consideration of effective contraceptive measures. If a woman plans pregnancy, the benefits and the risks of continuing treatment with Dovato should be discussed with the patient. Renal Impairment: Dovato is not recommended for patients with creatinine clearance <30 mL/min. Patients with a sustained creatinine clearance between 30 and 49 mL/min should be monitored for hematologic toxicities, which may require a dosage adjustment of lamivudine as an individual component
- Hepatic Impairment: Dovato is not recommended in patients with severe hepatic impairment (Child-Pugh Score C)
Please refer to the full European Summary of Product Characteristics for Dovato for full prescribing information, including contraindications, special warnings and precautions for use. For the US, please refer to the US Prescribing Information, including Boxed Warning.
Important Safety Information for Cabenuva (cabotegravir 200mg/mL; rilpivirine 300mg/mL) extended-release injectable suspensions (marketed as Vocabria/Rekambys outside the US)
Cabenuva is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents who are 12 years of age or older and weighing at least 35 kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than <50 copies per /mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.
- 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
WARNINGS AND PRECAUTIONS
- 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
- Serious or severe hypersensitivity reactions have been reported in association with other integrase inhibitors and could occur with Cabenuva
- Discontinue Cabenuva immediately if signs or symptoms of hypersensitivity reactions develop. Clinical status, including liver transaminases, should be monitored and appropriate therapy initiated.
- 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 inadvertent (partial) intravenous administration and began to resolve within a few minutes after the injection
- 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 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 (including depressed mood, depression, major depression, mood altered, mood swings, dysphoria, negative thoughts, suicidal ideation or attempt) have been reported with Cabenuva or the individual products
- Promptly evaluate patients with depressive symptoms
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
- The most common adverse reactions (incidence ≥2%, all grades) 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
- Refer to the applicable full Prescribing Information for important drug interactions with Cabenuva, VOCABRIA, or EDURANT
- 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 1A9 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
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: The CDC recommends that HIV 1−infected mothers in the United States not breastfeed their infants to avoid risking postnatal transmission of HIV-1 infection. Breastfeeding is also not recommended due to the potential for developing viral resistance in HIV-positive infants, adverse reactions in a breastfed infant, and detectable cabotegravir and rilpivirine concentrations in systemic circulation for up to 12 months or longer after discontinuing injections of Cabenuva
For more information please see US Prescribing Information for Cabenuva.
Important Safety Information for Rukobia (fostemsavir), 600 mg extended-release tablets
INDICATIONS AND USAGE
- RUKOBIA, a human immunodeficiency virus type 1 (HIV-1) gp120-directed attachment inhibitor, in combination with other antiretroviral(s), is indicated for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations.
- 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).
- 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.
- 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.
For more information please see US Prescribing Information for Rukobia.
|ViiV Healthcare enquiries:|
|Media enquiries:||Audrey Abernathy||+1 919 605 4521||(North Carolina)|
|Catherine Hartley||+44 (0) 7909 002 403||(London)|
|Media enquiries:||Tim Foley||+44 (0) 20 8047 5502||(London)|
|Madeleine Breckon||+44 (0) 20 8047 5502
|Kathleen Quinn||+1 202 603 5003
|Lyndsay Meyer||+1 202 302 4595
|Analyst/Investor enquiries:||Nick Stone||+44 (0) 7717 618834||(London)|
|Sonya Ghobrial||+44 (0) 7392 784784||(Consumer)|
|James Dodwell||+44 (0) 20 8047 2406||(London)|
|Mick Readey||+44 (0) 7990 339653||(London)|
|Josh Williams||+44 (0) 7385 415719||(London)|
|Jeff McLaughlin||+1 215 751 7002||(Philadelphia)|
Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the Company's Annual Report on Form 20-F for 2021, GSK’s Q2 Results for 2022 and any impacts of the COVID-19 pandemic.
Registered in England & Wales:
GSK plc ViiV Healthcare Limited
No. 3888792 No. 06876960
- P. Leone et.al. VH3810109 (N6LS) Reduces Viremia Across a Range of Doses in ART-Naive Adults Living with HIV: Proof of Concept Achieved in the Phase IIa BANNER (207959, NCT04871113) Study. Presented at HIV Glasgow 2022.
- M. A. Marzinke et. al., Laboratory analysis of HIV infections in the Year 1 unblinded period of HPTN 083: injectable cabotegravir for PrEP in MSM and TGW. Presented at HIV Glasgow 2022.
- S. DeWit et. al. CARISEL: A Hybrid III Implementation Effectiveness Study of Implementation of Cabotegravir Plus Rilpivirine Long Acting (CAB+RPV LA) in EU Health Care Settings; Key Clinical and Implementation Outcomes by Implementation Arm. Presented at IDWeek 2022.
- V. Chounta et. al. Patient-reported outcomes after 152 weeks of HIV maintenance therapy with long-acting cabotegravir + rilpivirine in the phase 3b ATLAS-2M study. Presented at HIV Glasgow 2022.
- G. Pierone et. al. Suppressed Switch to DTG/3TC 2-Drug Regimen vs BIC- or DTG-Based 3-Drug Regimens. Presented at IDWeek 2022.
- J. Borch et. al. 6-Month outcomes of every 2-months long-acting cabotegravir and rilpivirine in a real-world setting – effectiveness, adherence to injections and patient reported outcomes from PLHIV in the German CARLOS cohort. Presented at HIV Glasgow 2022.
- J. Scherzer et. al. The implementation of every 2-months cabotegravir and rilpivirine long-acting injections from the perspective of healthcare providers in the German CARLOS cohort, 6-month outcomes. Presented at HIV Glasgow 2022.
- R. Hsu US Healthcare Provider Perspectives on the Initiation of Cabotegravir and Rilpivirine Long-Acting (CAB+RPV LA) in an Observational Real-world Study (BEYOND). Presented at IDWeek 2022.