ViiV Healthcare announces European Commission Decision for Vocabria (cabotegravir) and Rekambys (rilpivirine) injections to be initiated with or without an oral lead-in period for the long-acting treatment of HIV
For media and investors only
ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (“GSK”), with Pfizer Inc. and Shionogi Limited as shareholders, announced that the European Commission has granted a decision to update the Summary of Product Characteristics (SmPC) for Vocabria (cabotegravir injections and tablets) and Janssen Pharmaceutical Companies of Johnson & Johnson’s Rekambys (rilpivirine long-acting injectable suspension) giving healthcare professionals and people living with HIV the option to start with injections, without the need for an oral lead-in of cabotegravir and rilpivirine. Oral cabotegravir and rilpivirine can be taken for a month to assess tolerability to the medicines, which is now optional with the SmPC update. The data showed that both initiation routes have similar safety and efficacy profiles.1,2
Harmony P. Garges, M.D., MPH,Chief Medical Officer at ViiV Healthcare said: “Being able to initiate cabotegravir and rilpivirine injections without an oral lead-in simplifies the initiation experience for both healthcare professionals and people living with HIV, meaning that they can start long-acting therapy sooner. People living with HIV can experience a range of challenges with daily oral antiretroviral therapy, including daily reminders of HIV and the fear of disclosing their HIV status. We are pleased that with this decision, they now have a choice of switching from their current oral therapy to a long-acting injectable therapy without having to transition through an oral lead-in. At ViiV Healthcare, we are proud to be able to offer innovative choices that meet the changing needs of people living with HIV.”
The decision from the European Commission was based on the phase III FLAIR clinical trial Week 124 results, and supported by extensive safety and tolerability data from Phase II and Phase III studies of oral cabotegravir and rilpivirine, prior to intramuscular injections, where no safety signals that would require the use of an oral lead-in were identified.3 Administration of cabotegravir and rilpivirine injections without the oral lead-in was investigated as part of an extension to the Phase III FLAIR clinical trial, with results showing that there were no meaningful differences in outcomes regarding maintenance of virologic suppression, safety, tolerability and pharmacokinetics in people starting cabotegravir and rilpivirine injections with or without the oral lead-in.2
ViiV Healthcare’s cabotegravir in combination with Janssen Pharmaceutical Companies of Johnson & Johnson’s rilpivirine was co-developed as part of a collaboration with Janssen and builds on ViiV Healthcare’s industry-leading portfolio that is centred on delivering innovative medicines for the HIV community.
About Vocabria (cabotegravir injection) and Rekambys (rilpivirine injection)1,2
Cabotegravir injection used in combination with rilpivirine injection is a complete long-acting regimen dosed monthly or every 2-months, for the treatment of HIV-1 in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class. Cabotegravir and rilpivirine injections are administered as two intramuscular (IM) injections in the buttocks by a healthcare professional at the same appointment.
The complete regimen combines the integrase strand transfer inhibitor (INSTI) cabotegravir, developed by ViiV Healthcare, with rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) developed by Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson.
INSTIs, like cabotegravir, inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic infection. Rilpivirine is an NNRTI that works by interfering with an enzyme called reverse transcriptase, which in turn stops the virus from multiplying.
Trademarks are owned by or licensed to the ViiV Healthcare group of companies.
Important Safety Information
The following Important Safety Information is based on the Summary of Product Characteristics for Vocabria. Please consult the full Summary of Product Characteristics for all the safety information.
Vocabria (cabotegravir)injection is indicated, in combination with rilpivirine injection, for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class. Vocabria injection is indicated for the treatment of HIV-1 in combination with rilpivirine injection, therefore, the prescribing information for rilpivirine injection should be consulted for recommended dosing.
Vocabria tablets are indicated in combination with rilpivirine tablets for the short-term treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class for:
- oral lead in to assess tolerability of Vocabria and rilpivirine prior to administration of long acting Vocabria injection plus long acting rilpivirine injection.
- oral therapy for adults who will miss planned dosing with Vocabria injection plus rilpivirine injection.
Vocabria tablets are only indicated for treatment of HIV-1 in combination with rilpivirine tablets, therefore, the prescribing information for Edurant tablets should also be consulted for recommended dosing.
Prior to starting Vocabria injection, healthcare professionals should have carefully selected patients who agree to the required injection schedule and counsel patients about the importance of adherence to scheduled dosing visits to help maintain viral suppression and reduce the risk of viral rebound and potential development of resistance with missed doses.
Following discontinuation of Vocabria and rilpivirine injection, it is essential to adopt an alternative, fully suppressive antiretroviral regimen no later than one month after the final injection of Vocabria when dosed monthly and no later than two months after the final injection of Vocabria when dosed every 2 months.
Elderly (≥65 years of age): No dose adjustment is required in elderly patients. There are limited data available on the use of cabotegravir in patients aged 65 years and over.
Paediatrics (<18 years of age): The safety and efficacy of Vocabria in children and adolescents aged under 18 years have not been established. No data are available.
Hypersensitivity to cabotegravir or rilpivirine or to any of the excipients.
Concomitant use with: rifampicin, rifapentine, carbamazepine, oxcarbazepine, phenytoin or phenobarbital.
Special Warnings and Precautions for Use
Risk of resistance following treatment discontinuation
To minimise the risk of developing viral resistance it is essential to adopt an alternative, fully suppressive antiretroviral regimen no later than one month after the final injection of Vocabria when dosed monthly and no later than two months after the final injection of Vocabria when dosed every 2 months.
Residual concentrations of cabotegravir may remain in the systemic circulation of patients for prolonged periods (up to 12 months or longer), therefore, physicians should take the prolonged release characteristics of Vocabria injection into consideration when the medicinal product is discontinued.
If virologic failure is suspected, an alternative regimen should be adopted as soon as possible.
Baseline factors associated with virological failure
Before starting the regimen, it should be taken into account that multivariable analyses indicate that a combination of at least 2 of the following baseline factors may be associated with an increased risk of virological failure: archived rilpivirine resistance mutations, HIV-1 subtype A6/A1, or BMI ≥30 kg/m2. In patients with an incomplete or uncertain treatment history without pre-treatment resistance analyses, caution is warranted in the presence of either BMI ≥30 kg/m2 or HIV-1 A6/A1 subtype.
Hypersensitivity reactions have been reported in association with other integrase inhibitors. These reactions were characterised by rash, constitutional findings and sometimes organ dysfunction, including liver injury. While no such reactions have been observed to date in association with Vocabria, physicians should remain vigilant and should discontinue Vocabria and other suspected medicinal products immediately, should signs or symptoms of hypersensitivity develop (including, but not limited to, severe rash, or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial oedema, hepatitis, eosinophilia or angioedema). Clinical status, including liver aminotransferases should be monitored and appropriate therapy initiated. Administration of oral lead-in is recommended to help identify patients who may be at risk of a hypersensitivity reaction.
Hepatotoxicity has been reported in a limited number of patients receiving Vocabria with or without known pre-existing hepatic disease.
Monitoring of liver chemistries is recommended and treatment with Vocabria should be discontinued if hepatotoxicity is suspected.
Patients with hepatitis B co-infection were excluded from studies with Vocabria. It is not recommended to initiate Vocabria in patients with hepatitis B co-infection. Physicians should refer to current treatment guidelines for the management of HIV infection in patients co-infected with hepatitis B virus.
Limited data is available in patients with hepatitis C co-infection. Monitoring of liver function is recommended in patients with hepatitis C co-infection.
Interactions with medicinal products
Caution should be given to prescribing Vocabria injection and tablets with medicinal products that may reduce its exposure.
Concomitant use of Vocabria injection with rifabutin is not recommended.
Polyvalent cation containing antacids are recommended to be taken at least 2 hours before and 4 hours after taking Vocabria tablets.
Effect of other medicinal products on the pharmacokinetics of cabotegravir
Cabotegravir is primarily metabolised by uridine diphosphate glucuronosyl transferase (UGT) 1A1 and to a lesser extent by UGT1A9. Medicinal products which are strong inducers of UGT1A1 or UGT1A9 are expected to decrease cabotegravir plasma concentrations leading to lack of efficacy.
Summary of the safety profile
The most frequently reported adverse reactions (ARs) from monthly dosing studies were injection site reactions (up to 84%), headache (up to 12%) and pyrexia* (10%).
The most frequently reported ARs from ATLAS-2M every 2-month dosing were injection site reactions (76%), headache (7%) and pyrexia* (7%).
*Pyrexia includes the following: feeling hot, body temperature increased.
Description of selected adverse reactions
Local injection site reactions (ISRs)
Up to 1% of subjects discontinued treatment with Vocabria plus rilpivirine because of ISRs. When dosing monthly, up to 84% of subjects reported injection site reactions; out of 30393 injections, 6815 ISRs were reported. When dosing every 2 months, 76% of patients reported injection site reactions; out of 8470 injections, 2507 ISRs were reported.
The severity of reactions was generally mild (Grade 1, 70%-75% of subjects) or moderate (Grade 2, 27%-36% of subjects). 3-4% of subjects experienced severe (Grade 3) ISRs. The median duration of overall ISR events was 3 days. The percentage of subjects reporting ISRs decreased over time.
At the Week 48 time point, subjects in studies FLAIR and ATLAS, who received Vocabria plus rilpivirine gained a median of 1.5 kg in weight subjects continuing on their current antiretroviral therapy (CAR) gained a median of 1.0 kg (pooled analysis). In the individual studies FLAIR and ATLAS, the median weight gains in the Vocabria plus rilpivirine arms were 1.3 kg and 1.8 kg respectively, compared to 1.5 kg and 0.3 kg in the CAR arms.
At the 48 week timepoint, in ATLAS-2M the median weight gain in both the monthly and 2-monthly CAB+RPV dosing arms was 1.0 kg.
There are a limited amount of data from the use of cabotegravir in pregnant women. The effect of Vocabria on human pregnancy is unknown.
Cabotegravir was not teratogenic when studied in pregnant rats and rabbits but, exposures higher than the therapeutic dose showed reproductive toxicity in animals. The relevance to human pregnancy is unknown.
Vocabria injection is not recommended during pregnancy unless the expected benefit justifies the potential risk to the foetus.
Cabotegravir has been detected in systemic circulation for up to 12 months or longer after an injection
It is expected that cabotegravir will be secreted into human milk based on animal data, although this has not been confirmed in humans. Cabotegravir may be present in human milk for up to 12 months or longer after the last cabotegravir injection.
It is recommended that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.
Rekambys (rilpivirine injection) ISI
The following Important Safety Information is based on the Summary of Product Characteristics for REKAMBYS (rilpivirine injection). Please consult the full Summary of Product Characteristics for all the safety information.
REKAMBYS is indicated, in combination with cabotegravir injection, for the treatment of human immunodeficiency virus type 1 (HIV‑1) infection in adults who are virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with, agents of the NNRTI and INI class.
REKAMBYS should always be co-administered with a cabotegravir injection. The prescribing information for cabotegravir injection should be consulted for recommended dosing.
REKAMBYS may be initiated with oral lead-in or without (direct to injection).
The healthcare professional and patient may decide to use rilpivirine tablets as an oral lead-in prior to the initiation of REKAMBYS injections to assess tolerability or proceed directly to REKAMBYS therapy.
When used for oral lead-in prior to the initiation of REKAMBYS, rilpivirine oral tablets, together with cabotegravir oral tablets, should be taken for approximately 1 month (at least 28 days) to assess tolerability to rilpivirine and cabotegravir. One rilpivirine 25mg tablet should be taken with a meal with one cabotegravir 30mg tablet once daily.
Prior to starting REKAMBYS, the healthcare professional should carefully select patients who agree to the required injection schedule and counsel patients about the importance of adherence to scheduled dosing visits to help maintain viral suppression and reduce the risk of viral rebound and potential development of resistance associated with missed doses.
Following discontinuation of REKAMBYS in combination with cabotegravir injection, it is essential to adopt an alternative, fully suppressive antiretroviral regimen no later than one month after the last every 1 month injection of REKAMBYS or two months after the last every 2 months injection of REKAMBYS.
Elderly: There is limited information regarding the use of REKAMBYS in patients > 65 years of age. No dose adjustment of REKAMBYS is required in older patients.
Paediatric Patients: The safety and efficacy of REKAMBYS in children and adolescents aged < 18 years have not been established. No data are available.
Hypersensitivity to the active substance or to any of the excipients.
REKAMBYS must not be co-administered with the following medicinal products, which may result in loss of therapeutic effect of REKAMBYS:
- the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, phenytoin
- the antimycobacterials rifabutin, rifampicin, rifapentine
- the systemic glucocorticoid dexamethasone, except as a single dose treatment
- St John’s wort (Hypericum perforatum).
Special Warnings and Precautions for Use
Risk of resistance following treatment discontinuation
To minimise the risk of developing viral resistance it is essential to adopt an alternative, fully suppressive antiretroviral regimen no later than one month after the last every 1 month injection of REKAMBYS or two months after the last every 2 months injection of REKAMBYS.If virologic failure is suspected, an alternative regimen should be adopted as soon as possible.
Long-acting properties of rilpivirine injection
Residual concentrations of rilpivirine may remain in the systemic circulation of patients for prolonged periods (up to 4 years in some patients) and should be considered upon discontinuation of REKAMBYS.
Baseline factors associated with virological failure
Before starting the regimen, it should be taken into account that multivariable analyses indicate that a combination of at least 2 of the following baseline factors may be associated with an increased risk of virological failure: archived rilpivirine resistance mutations, HIV-1 subtype A6/A1, or BMI ≥30 kg/m2. In patients with an incomplete or uncertain treatment history without pre-treatment resistance analyses, caution is warranted in the presence of BMI ≥30 kg/m2 and/or HIV-1 subtype A6/A1.
Partial intravenous administration may result in AEs due to temporarily high plasma concentrations. In clinical studies, serious post-injection reactions were reported within minutes after the injection of rilpivirine, including dyspnoea, agitation, abdominal cramping, flushing, sweating, oral numbness, and changes in blood pressure. These events were very rare and began to resolve within a few minutes after the injection.
Carefully follow the Instructions for Use when preparing and administering REKAMBYS to avoid accidental intravenous administration. Observe patients briefly (approximately 10 minutes) after the injection. If a patient experiences a post-injection reaction, monitor and treat as clinically indicated.
REKAMBYS should be used with caution when co‑administered with a medicinal product with a known risk of Torsade de Pointes. At supra‑therapeutic doses (75 and 300 mg once daily), oral rilpivirine has been associated with prolongation of the QTc interval of the electrocardiogram (ECG). Oral rilpivirine at the recommended dose of 25 mg once daily is not associated with a clinically relevant effect on QTc. Plasma rilpivirine concentrations after REKAMBYS injections are comparable to those during such oral rilpivirine therapy.
Patients with hepatitis B co-infection were excluded from studies with REKAMBYS. It is not recommended to initiate REKAMBYS in patients with hepatitis B co-infection. In patients co‑infected with hepatitis B receiving oral rilpivirine, the incidence of hepatic enzyme elevation was higher than in patients receiving oral rilpivirine who were not hepatitis B co‑infected. Physicians should refer to current treatment guidelines for the management of HIV infection in patients co-infected with hepatitis B virus.
Limited data is available in patients with hepatitis C co-infection. In patients co‑infected with hepatitis C receiving oral rilpivirine, the incidence of hepatic enzyme elevation was higher than in patients receiving oral rilpivirine who were not hepatitis C co‑infected. The pharmacokinetic exposure of oral and injectable rilpivirine in co‑infected patients was comparable to that in patients without hepatitis C co‑infection. Monitoring of liver function is recommended in patients with hepatitis C co-infection.
Interactions with other medicinal products
REKAMBYS should not be administered with other antiretroviral medicinal products, except for cabotegravir injection for the treatment of HIV-1 infection.
There are limited data of REKAMBYS in pregnant women. REKAMBYS is not recommended during pregnancy unless the expected benefit justifies the potential risk. Lower exposures of oral rilpivirine were observed when rilpivirine 25 mg once daily was taken during pregnancy. In the Phase 3 studies with oral rilpivirine, lower rilpivirine exposure, similar to that seen during pregnancy, has been associated with an increased risk of virological failure, therefore viral load should be monitored closely. Alternatively, switching to another ART regimen could be considered.
Immune reactivation syndrome
In HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms. Typically, such reactions have been observed within the first few weeks or months of initiation of CART. Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jirovecii pneumonia. Any inflammatory symptoms should be evaluated and treatment instituted when necessary. Autoimmune disorders (such as Graves’ disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reconstitution, however, the reported time to onset is more variable and these events can occur many months after initiation of treatment.
Transmission of HIV
While effective viral suppression with antiretroviral therapy has been proven to substantially reduce the risk of sexual transmission, a residual risk cannot be excluded. Precautions to prevent transmission should be taken in accordance with national guidelines.
Patients should be advised that REKAMBYS or any other antiretroviral therapy does not cure HIV infection and that they may still develop opportunistic infections and other complications of HIV infection. Therefore, patients should remain under close clinical observation by physicians experienced in the treatment of these associated HIV diseases.
This medicine contains less than 1 mmol sodium (23 mg) per injection, that is to say essentially ‘sodium-free’.
The most frequently reported ARs from every 1 month dosing studies were injection site reactions (up to 84%), headache (up to 12%) and pyrexia (10%).
The most frequently reported ARs from every 2 months dosing were injection site reactions (76%), headache (7%) and pyrexia (7%).
Tabulated list of adverse reactions is available in the full information leaflet.
The overall safety profile at Week 96 and Week 124 in the FLAIR study was consistent with that observed at Week 48, with no new safety findings identified. In the extension phase of the FLAIR study, initiating the rilpivirine plus cabotegravir injection regimen without oral lead-in (direct to injection) was not associated with any new safety concerns related to omitting the oral lead-in phase.
Description of selected adverse reactions
Local Injection Site Reactions (ISRs)
Up to 1% of subjects discontinued treatment with rilpivirine and cabotegravir injections because of ISRs. When dosed every 1 month in ATLAS, FLAIR, and ATLAS-2M (Q4W arm), up to 84% of subjects reported injections site reactions; out of 30393 injections, 6815 ISRs were reported. When dosed every 2 months in ATLAS-2M (Q8W arm), 76% of subjects reported injection site reactions; out of 8470 injections, 2507 ISRs were reported.
Injection site reactions were generally mild (Grade 1, 70%-75% of subjects) or moderate (Grade 2, 27%-36% of subjects). 3-4% of subjects experienced severe (Grade 3) ISRs. The median duration of ISR events was 3 days. The percentage of subjects reporting ISRs decreased over time.
At the Week 48 time point, subjects in Phase 3 Studies FLAIR and ATLAS, who received rilpivirine plus cabotegravir gained a median of 1.5 kg in weight; subjects continuing on their current antiretroviral regimen (CAR) group gained a median of 1.0 kg (pooled analysis). In the individual studies FLAIR and ATLAS, the median weight gains in the rilpivirine plus cabotegravir arms were 1.3 kg and 1.8 kg respectively, compared to 1.5 kg and 0.3 kg in the CAR arms.
At the 48 week timepoint, in ATLAS-2M the median weight gain in both the monthly and every 2 months rilpivirine + cabotegravir dosing arms was 1.0 kg.
Changes in laboratory chemistry
Changes in laboratory chemistry Elevated transaminases (ALT/AST) were observed in subjects receiving rilpivirine plus cabotegravir during the clinical studies. These elevations were primarily attributed to acute viral hepatitis. A few subjects on oral rilpivirine plus oral cabotegravir treatment had transaminase elevations attributed to suspected drug-related hepatotoxicity; these changes were reversible upon discontinuation of treatment. Small, non-progressive increases in total bilirubin (without clinical jaundice) were observed with treatment with rilpivirine plus cabotegravir. These changes are not considered clinically relevant as they likely reflect competition between cabotegravir and unconjugated bilirubin for a common clearance pathway (UGT1A1). Elevated lipases were observed during clinical trials with rilpivirine plus cabotegravir. Grade 3 and 4 lipase increases occurred at a higher incidence with rilpivirine plus cabotegravir compared with CAR. These elevations were generally asymptomatic and did not lead to rilpivirine plus cabotegravir discontinuation. One case of fatal pancreatitis with Grade 4 lipase and confounding factors (including history of pancreatitis) has been reported in study ATLAS-2M for which the causality to the injection regimen could not be ruled out.
The effect of REKAMBYS on human pregnancy is unknown. A moderate amount of data with oral rilpivirine in pregnant women (between 300-1000 pregnancy outcomes) indicate no malformative or foetal/neonatal toxicity of rilpivirine. A study of 19 pregnant women treated with oral rilpivirine in combination with a background regimen during the second and third trimesters, and postpartum, showed lower exposures of oral rilpivirine during pregnancy, therefore viral load should be monitored closely if REKAMBYS is used during pregnancy.
Animal studies do not indicate reproductive toxicity. REKAMBYS is not recommended during pregnancy unless the expected benefit justifies the potential risk.
An alternative oral regimen should be considered in line with current treatment guidelines. After discontinuation of REKAMBYS, rilpivirine may remain in systemic circulation for up to 4 years in some patients.
It is expected that rilpivirine will be secreted into human milk based on animal data, although this has not been confirmed in humans. Rilpivirine may be present in human milk for up to 4 years in some patients after discontinuation of REKAMBYS.
It is recommended that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.
About ViiV Healthcare
ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of becoming infected with HIV. Shionogi joined as shareholders in October 2012. The company’s aims are to take a deeper and broader interest in HIV and AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV.
For more information on the company, its management, portfolio, pipeline, and commitment, please visit www.viivhealthcare.com.
GSK is a science-led global healthcare company. For further information please visit https://www.gsk.com/en-gb/about-us/.
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 2020 and any impacts of the COVID-19 pandemic.
Registered in England & Wales:
ViiV Healthcare Limited
980 Great West Road
1 Vocabria EU Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/vocabria-epar-product-information_en.pdf. Last accessed October 2021.2 Rekambys EU Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/rekambys-epar-product-information_en.pdf Last access October 2021
3 D'Amico R, Orkin C, Morell EB, et al. Safety and efficacy of cabotegravir + rilpivirine long-acting with and without oral lead-in: FLAIR Week 124 results. Presented at HIV Glasgow 2020.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
ViiV Healthcare enquiries:
Melinda Stubbee +1 919 491 0831 (North Carolina)
Benjamyn Tan +44 (0) 7780 494 823 (London)
Tim Foley +44 (0) 20 8047 5502 (London)
Kathleen Quinn +1 202 603 5003 (Washington DC)
James Dodwell +44 (0) 20 8047 2406 (London)
Mick Readey +44 (0) 7990 339653 (London)
Jeff McLaughlin +1 215 751 7002 (Philadelphia)
Frannie DeFranco +1 215 751 4855 (Philadelphia)
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Nel ASA: Receives Purchase Order for 20MW Alkaline Electrolyser From Ovako26.11.2021 20:45:00 CET | Press release
Nel Hydrogen Electrolyser AS, a division of Nel ASA (Nel, OSE:NEL), has received a purchase order for a 20MW alkaline water electrolyser from Ovako, a leading European manufacturer of engineering steel. The electrolyser will be installed at Ovako’s existing plant in Hofors, Sweden. The fossil-free hydrogen will replace the use of fossil propane gas currently used in the heating furnaces. “We are excited to announce the delivery of electrolyser equipment to Ovako. There is huge potential in reducing CO2-emissions from steel-heating processes through green hydrogen. We look forward to working with Ovako and its partners to further develop fossil-free steel production,” says Jon André Løkke, CEO at Nel. The purchase order has a contract value of approximately EUR 11 million with equipment delivery in late 2022. The electrolyser will produce oxygen and hydrogen for Ovako’s steel-heating process and is a major step towards zero-carbon emission steel production. The conversion to hydrogen wi
'Afghan Girl' Sharbat Gula Safely Evacuated to Italy Via Efforts of Photographer Steve McCurry, Metagood/OnChainMonkey Crypto Community & Future Brilliance Charity26.11.2021 18:16:00 CET | Press release
The legendary 'Afghan Girl' photographer, Steve McCurry, and his sister, Bonnie McCurry, are delighted to announce that, together with the British-American charity, Future Brilliance, and with the support of the Italian government, and NFT for Social Good platform Metagood, they have been able to bring the famous icon for Afghan female refugees, Sharbat Gula, to safety. Background: Six weeks ago, Bonnie McCurry reached out to Future Brilliance founder, impact pioneer, and investor Sophia Swire who has a 30-year track record of empowering women in Afghanistan. She told Sophia that Sharbat Gula wanted to be evacuated with her family. After considering all the various country options, they confirmed with Sharbat that her family hoped to seek asylum in Italy. Sophia and her team activated the Future Brilliance network in Afghanistan and, together with the McCurry family, arranged the necessary paperwork, visas, and logistics. The NFT for good platform Metagood (who worked with McCurry to d
ZOVOO Held Distributor Conference, Creating a Splash of Colour in Atomization Industry26.11.2021 16:45:00 CET | Press release
At 9:30pm (GMT +8) on November 12, ZOVOO, a new industry-leading atomization company, held its 2021 distributor conference online. Distributors from United States, United Kingdom, France and other countries participated in the conference. Meanwhile, ZOVOO also displayed its newly developed disposable products DRAGBAR series for the first time to the public, which attracted widespread attention from distributors worldwide. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211126005521/en/ (Photo: Business Wire) Founded in 2010, ZOVOO has sophisticated research and develop capability, forward-looking product design and perfect supply chain system. ZOVOO founding team has 10 years of proven strength and experience. They have the absolute advantages in terms of heating materials, air channel structure design, etc., and build up the five criteria of good flavor. The birth of each product needs to go through from R&D, design, product
Indeed and Quandoo Announce Partnership to Support the Restaurant Industry Hiring Crisis26.11.2021 15:21:00 CET | Press release
Indeed, the world’s largest jobs site, and Quandoo, one of the fastest growing restaurant reservation platforms worldwide, today announce a partnership to support the restaurant industry's current hiring crisis. This partnership will see restaurants be provided with £50 credit to post a sponsored job advertisement on Indeed’s platform. Sponsored jobs advertisements receive optimal visibility and are more likely to deliver hires* which Indeed and Quandoo hope will connect staff with the restaurants that need them the most. Employers posting a job on Indeed for the first time will have £50 credited to their account to start sponsoring their jobs and reaching more candidates. Employers in the UK can claim the offer here. “We are so excited about this partnership. It’s a topic that is close to home for us at Quandoo as we are hearing how challenging it is to find staff from our partners. So we wanted to do our bit to support the wider industry in any way we can. By partnering with Indeed w
The Leading Event for Payment, Identification and Security Professionals, TRUSTECH will present all the Latest trends in the sector26.11.2021 10:34:00 CET | Press release
For three days, professionals of the cards and digital trust technologies industries will meet at the TRUSTECH exhibition in Paris to discuss the issues and challenges of identity, security and payment, which are the real pillars of the digital transition for institutional or commercial organisations. A panel of international speakers will share their insights across the multiple conference sessions The 6,000 attendees expected from all over the world will also be able to discover concrete solutions to optimise their business and develop their practices. Visitors will have FREE access to participateat Trustech conferences program. AUTHENTICATION AND IDENTIFICATION: A STRATEGIC ISSUE FOR GOVERNMENTS AND ORGANISATIONS These new demands on governments require the use of increasingly complex technologies and processes.Digitization brings into question how the use of physical official documents will be used in the future. It also implies there will be new innovations regarding how physical
Vifor Pharma supports Iron Deficiency Day 2021: Call to action for early iron deficiency diagnosis26.11.2021 07:00:00 CET | Press release
Already for the seventh consecutive year of Iron Deficiency Day, Vifor Pharma is supporting a growing international alliance including the Heart Failure Policy Network, European Kidney Health Alliance, Global Heart Hub and Croí the West of Ireland Cardiac Foundation with the aim to educate people about the importance of iron for the body and what can happen if iron levels are not properly managed. Iron Deficiency Day 2021 encourages people at risk to listen to their body, to take iron seriously and to take control over their health by seeking early diagnosis and medical help from their physician. Iron Deficiency affects about half of the patients with chronic kidney disease2 and chronic heart failure and is associated with reduced quality of life3, an increased risk of hospitalization4 and cardiovascular death5. Despite the serious consequences and high prevalence, of iron deficiency, the condition remains under-recognized6. Diagnosis and treatment of iron deficiency has been further i
LightCON Unveils Global Teaser Site for New Mobile Game 'Rise of Stars (ROS)'26.11.2021 03:00:00 CET | Press release
Rise of Stars (ROS), a new mobile game that is being developed by LightCON, a subsidiary of WEMADE MAX (Co-CEOs: Hyunguk Chang, Gilhyung Lee) (KOSDAQ: 101730), today opened its global teaser site. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211125006252/en/ LightCON unveils global teaser site for new mobile game 'Rise of Stars (ROS).' ROS is a new mobile SF strategy game featuring elaborately designed warships and planets set in the vast universe. Under the slogan, 'The 4x Blockchain Game for the Greatest Conqueror,' the teaser site was designed to help users experience the unique atmosphere of ROS and the game concept with the representative image of the game. ROS will be building a system for players to obtain game tokens through resource mining within planets. It aims for a global launch in the 1st quarter of 2022. (Graphic: Business Wire) Under the slogan, ‘The 4x Blockchain Game for the Greatest Conqueror,’ the tease