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Yahoo
3 days ago
- Business
- Yahoo
GSK Stock Rises Almost 22% in 6 Months: Time to Buy, Sell or Hold?
GSK GSK stock has risen 21.5% in the past six months. The consistently strong performance of the Specialty Medicines unit, regulatory and pipeline successes and an optimistic outlook for the long term are the key factors driving the increase amid several headwinds like slowing sales in the Vaccines unit, generic competition for some drugs and broader economic pressure. Let's discuss these factors in detail to understand how to play GSK's stock amid the recent price increase. GSK is witnessing increased sales growth of its Specialty Medicines unit, particularly reflecting successful new launches in Oncology and long-acting HIV medicines. Sales are rising in all areas, HIV, Immunology/Respiratory as well as Oncology. Sales of the Specialty Medicines unit rose 19% in 2024, driven by double-digit growth in all therapy areas. The positive trend continues in 2025 with sales rising 17% in the first quarter of 2025. In the segment, while products like Nucala and Dovato are key top-line drivers, new long-acting HIV medicines, Cabenuva and Apretude, as well as new oncology drugs Jemperli and Ojjaara, are also witnessing strong patient demand and contributing to top-line growth. In 2025, the company expects sales in the Specialty Medicines segment to rise in a low double-digit percentage at CER, despite the impact from the Inflation Reduction Act or IRA. Specialty Medicines, which now accounts for around 40% of GSK's sales, is expected to be more than 50% of GSK's total revenue by 2031. GSK is increasing R&D investment in promising new long-acting and specialty medicines in Respiratory, Immunology & Inflammation, Oncology and HIV areas. GSK's pentavalent MenABCWY meningococcal vaccine and Blujepa/gepotidacin for treating uncomplicated urinary tract infection ('UTI') were approved in the United States in the first quarter of 2025. Its blockbuster drug Nucala was approved for treating chronic obstructive pulmonary disease or COPD, its fifth indication, in May 2025. Regulatory applications seeking approval of the Blenrep combination for relapsed/refractory multiple myeloma and depemokimab for two indications (chronic rhinosinusitis with nasal polyps or CRSwNP and asthma with type II inflammation) are under review in the United States and some other countries. FDA decisions on all these filings are expected in 2025. Blenrep combinations were approved in the United Kingdom and Japan in April/May 2025. In 2025, GSK expects to launch five new products/line extensions, including Blenrep, depemokimab (severe asthma and CRSwNP), Nucala for COPD, Penmenvy and Blujepa. Of these, Penmenvy, Blujepa and Nucala for COPD are already approved in the United States. GSK's first-quarter Vaccine sales declined 6% due to lower sales of its RSV vaccine, Arexvy, and shingles vaccine, Shingrix. U.S. sales of Shingrix declined 21% in the first quarter of 2025 due to lower demand as a result of challenges in activating harder-to-reach consumers. Arexvy's global sales declined 57% in the first quarter. Revised recommendations for RSV vaccinations issued in June 2024 by the U.S. Advisory Committee on Immunization Practices (ACIP) have been hurting sales of Arexvy from the second half of 2024 in the United States. In June, the ACIP recommended the use of Arexvy for all adults aged 75 and above. However, for adults aged 60-74, the ACIP recommended the vaccine only for those who are at increased risk of severe RSV disease. A challenging macro environment in China and potential for changes in vaccination policies in the United States are expected to hurt Vaccine sales in the near term. In 2025, the company expects sales in the Vaccines segment to decline by a low single-digit percentage at CER. GSK stock has risen 20.1% year to date compared with an increase of 4.0% for the industry. The stock has also outperformed the sector and the S&P 500 index, as seen in the chart below. The stock has also been trading above 200 and 50-day moving averages since May. Image Source: Zacks Investment Research GSK's stock is trading at an attractive valuation relative to the industry. Going by the price/earnings ratio, the company's shares currently trade at 8.63 on a forward 12-month basis, lower than 15.63 for the industry. The stock also trades below its 5-year mean of 10.25. The stock is much cheaper than several other large drugmakers like Eli Lilly LLY, Novo Nordisk NVO, AbbVie ABBV and AstraZeneca. Image Source: Zacks Investment Research The Zacks Consensus Estimate for earnings has risen from $4.26 to $4.42 per share for 2025 and from $4.71 to $4.82 per share for 2026 over the past 60 days. Image Source: Zacks Investment Research GSK has its share of problems. Competitive pressure on HIV and respiratory drugs has risen. The dolutegravir HIV franchise patent expires in the 2028-2029 period, and U.S. vaccine sales are slowing down. In 2025, GSK also expects a negative sales impact of £400-500 million due to the impact of the IRA Medicare Part D redesign. However, the company is consistently growing its sales and profits, mainly driven by its Specialty Medicines segment. For the five-year period till 2026, GSK expects to record more than 7% sales growth while core operating profit is expected to increase more than 11% on a CAGR basis. In this period, Specialty Medicines is expected to rise in the low-to-mid teens percentage while General Medicines is expected to rise by a low single-digit percentage. The growth in Specialty Medicines and improvement in General Medicines are making up for a slowdown in the Vaccines unit. The company also resolved the vast majority of Zantac litigations in 2024, which had long been an overhang on the stock. GSK believes it is well-positioned to navigate and mitigate the potential financial impact of tariffs on pharmaceutical imports through supply chain and increased productivity initiatives We suggest investors who own this Zacks Rank #3 (Hold) stock stay invested for now, considering steady sales and profit improvement in the coming years. Consistently rising estimates also reflect analysts' optimistic outlook for future growth in profits. Buying the stock at its present cheap valuation can prove prudent for long-term investors who are interested in buying blue-chip companies. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report GSK PLC Sponsored ADR (GSK) : Free Stock Analysis Report Novo Nordisk A/S (NVO) : Free Stock Analysis Report Eli Lilly and Company (LLY) : Free Stock Analysis Report AbbVie Inc. (ABBV) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Globe and Mail
3 days ago
- Business
- Globe and Mail
GSK Stock Rises Almost 22% in 6 Months: Time to Buy, Sell or Hold?
GSK GSK stock has risen 21.5% in the past six months. The consistently strong performance of the Specialty Medicines unit, regulatory and pipeline successes and an optimistic outlook for the long term are the key factors driving the increase amid several headwinds like slowing sales in the Vaccines unit, generic competition for some drugs and broader economic pressure. Let's discuss these factors in detail to understand how to play GSK's stock amid the recent price increase. GSK Specialty Medicines Unit on a Strong Footing GSK is witnessing increased sales growth of its Specialty Medicines unit, particularly reflecting successful new launches in Oncology and long-acting HIV medicines. Sales are rising in all areas, HIV, Immunology/Respiratory as well as Oncology. Sales of the Specialty Medicines unit rose 19% in 2024, driven by double-digit growth in all therapy areas. The positive trend continues in 2025 with sales rising 17% in the first quarter of 2025. In the segment, while products like Nucala and Dovato are key top-line drivers, new long-acting HIV medicines, Cabenuva and Apretude, as well as new oncology drugs Jemperli and Ojjaara, are also witnessing strong patient demand and contributing to top-line growth. In 2025, the company expects sales in the Specialty Medicines segment to rise in a low double-digit percentage at CER, despite the impact from the Inflation Reduction Act or IRA. Specialty Medicines, which now accounts for around 40% of GSK's sales, is expected to be more than 50% of GSK's total revenue by 2031. GSK's Promising Pipeline GSK is increasing R&D investment in promising new long-acting and specialty medicines in Respiratory, Immunology & Inflammation, Oncology and HIV areas. GSK's pentavalent MenABCWY meningococcal vaccine and Blujepa/gepotidacin for treating uncomplicated urinary tract infection ('UTI') were approved in the United States in the first quarter of 2025. Its blockbuster drug Nucala was approved for treating chronic obstructive pulmonary disease or COPD, its fifth indication, in May 2025. Regulatory applications seeking approval of the Blenrep combination for relapsed/refractory multiple myeloma and depemokimab for two indications (chronic rhinosinusitis with nasal polyps or CRSwNP and asthma with type II inflammation) are under review in the United States and some other countries. FDA decisions on all these filings are expected in 2025. Blenrep combinations were approved in the United Kingdom and Japan in April/May 2025. In 2025, GSK expects to launch five new products/line extensions, including Blenrep, depemokimab (severe asthma and CRSwNP), Nucala for COPD, Penmenvy and Blujepa. Of these, Penmenvy, Blujepa and Nucala for COPD are already approved in the United States. GSK's Vaccine Sales Slowing Down GSK's first-quarter Vaccine sales declined 6% due to lower sales of its RSV vaccine, Arexvy, and shingles vaccine, Shingrix. U.S. sales of Shingrix declined 21% in the first quarter of 2025 due to lower demand as a result of challenges in activating harder-to-reach consumers. Arexvy's global sales declined 57% in the first quarter. Revised recommendations for RSV vaccinations issued in June 2024 by the U.S. Advisory Committee on Immunization Practices (ACIP) have been hurting sales of Arexvy from the second half of 2024 in the United States. In June, the ACIP recommended the use of Arexvy for all adults aged 75 and above. However, for adults aged 60-74, the ACIP recommended the vaccine only for those who are at increased risk of severe RSV disease. A challenging macro environment in China and potential for changes in vaccination policies in the United States are expected to hurt Vaccine sales in the near term. In 2025, the company expects sales in the Vaccines segment to decline by a low single-digit percentage at CER. GSK's Price Performance, Valuation & Estimate Movement GSK stock has risen 20.1% year to date compared with an increase of 4.0% for the industry. The stock has also outperformed the sector and the S&P 500 index, as seen in the chart below. The stock has also been trading above 200 and 50-day moving averages since May. GSK Stock Outperforms Industry, Sector and S&P GSK's stock is trading at an attractive valuation relative to the industry. Going by the price/earnings ratio, the company's shares currently trade at 8.63 on a forward 12-month basis, lower than 15.63 for the industry. The stock also trades below its 5-year mean of 10.25. The stock is much cheaper than several other large drugmakers like Eli Lilly LLY, Novo Nordisk NVO, AbbVie ABBV and AstraZeneca. GSK Stock Valuation Image Source: Zacks Investment Research The Zacks Consensus Estimate for earnings has risen from $4.26 to $4.42 per share for 2025 and from $4.71 to $4.82 per share for 2026 over the past 60 days. GSK's Estimates Stay Invested in GSK Stock GSK has its share of problems. Competitive pressure on HIV and respiratory drugs has risen. The dolutegravir HIV franchise patent expires in the 2028-2029 period, and U.S. vaccine sales are slowing down. In 2025, GSK also expects a negative sales impact of £400-500 million due to the impact of the IRA Medicare Part D redesign. However, the company is consistently growing its sales and profits, mainly driven by its Specialty Medicines segment. For the five-year period till 2026, GSK expects to record more than 7% sales growth while core operating profit is expected to increase more than 11% on a CAGR basis. In this period, Specialty Medicines is expected to rise in the low-to-mid teens percentage while General Medicines is expected to rise by a low single-digit percentage. The growth in Specialty Medicines and improvement in General Medicines are making up for a slowdown in the Vaccines unit. The company also resolved the vast majority of Zantac litigations in 2024, which had long been an overhang on the stock. GSK believes it is well-positioned to navigate and mitigate the potential financial impact of tariffs on pharmaceutical imports through supply chain and increased productivity initiatives We suggest investors who own this Zacks Rank #3 (Hold) stock stay invested for now, considering steady sales and profit improvement in the coming years. Consistently rising estimates also reflect analysts' optimistic outlook for future growth in profits. Buying the stock at its present cheap valuation can prove prudent for long-term investors who are interested in buying blue-chip companies. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. 5 Stocks Set to Double Each was handpicked by a Zacks expert as the #1 favorite stock to gain +100% or more in the coming year. While not all picks can be winners, previous recommendations have soared +112%, +171%, +209% and +232%. Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor. Today, See These 5 Potential Home Runs >> Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report GSK PLC Sponsored ADR (GSK): Free Stock Analysis Report Novo Nordisk A/S (NVO): Free Stock Analysis Report Eli Lilly and Company (LLY): Free Stock Analysis Report AbbVie Inc. (ABBV): Free Stock Analysis Report
Yahoo
17-03-2025
- Business
- Yahoo
ViiV to trial twice-yearly HIV antibody dosing after Phase IIb success
ViiV Healthcare is looking to investigate twice-yearly dosing of its human immunodeficiency virus (HIV) therapy, which has been able to suppress viral load in patients dosed every four months in a Phase IIb trial. Results from the company's Embrace trial (NCT05996471) found that 96% of patients dosed with 60mg/kg N6LS (VH109) intravenously (IV), were able to maintain HIV-1 RNA levels below 50 copies per millimetre in blood, compared to 96% in the standard-of-care (SoC) group, who received antiretroviral therapies (ART). At the same time, 88% of another group receiving 3,000mg of N6LS subcutaneously alongside recombinant human hyaluronidase (rHuPH20), were also able to achieve the same effect, maintaining viral load below detectable levels. N6LS was administered in both arms every four months, combined with monthly cabotegravir long-acting injections, in this case using the company's other proprietary HIV regimen, Cabenuva (cabotegravir and rilpivirine). Virologic failure was observed in two patients from each group. Results from the Embrace trial were presented as part of the 2025 Conference on Retroviruses and Opportunistic Infections (CROI) in San Francisco, with the company adding that it plans to advance N6LS to six-monthly IV dosing in combination with Cabenuva as part of the Embrace part two study. ViiV Healthcare research and development head Kimberly Smith said: 'The Embrace study demonstrated that VH109, a CD4-binding broadly neutralising antibody, administered every four months with cabotegravir, achieved high efficacy and was well tolerated through six months. 'We're looking forward to continuing the development of VH109 as a component of our future ultra-long-acting regimens.' The London-based company is majority-owned by UK pharmaceutical giant GSK with companies such as Pfizer and Shionogi holding minority shares in the company. The Phase IIb multi-centre, randomised, open-label study recruited 134 patients at 45 locations across the US. The company describes N6LS as a broadly neutralising antibody (bNAbs), a type of antibody that can recognise and block the entry of a broad range of different strains of HIV into healthy cells. The trial secondary endpoint examining the number of AEs found that 64% of the IV group and 65% of the subcutaneous group experienced some form of treatment-related AE. 16% of patients in the subcutaneous group experienced grade 3 and 4 erythema. Infusion site reactions were reported in no IV patients, but 14% of patients in the subcutaneous group. Research by GlobalData's pharmaceutical research centre details that should N6LS make it to market, it is estimated to bring in $41m for ViiV Healthcare, with that figure expected to rise to $247m by the end of 2031. GlobalData is the parent company of Clinical Trials Arena. Elsewhere in the world of HIV therapies, Gilead is set to launch a Phase III trial of its once-yearly lenacapavir pre-exposure prophylaxis (PrEP) for the disease. Meanwhile, massive cutbacks in USAID funding are set to have ramifications on international research in diseases such as HIV. "ViiV to trial twice-yearly HIV antibody dosing after Phase IIb success" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Yahoo
13-03-2025
- Business
- Yahoo
ViiV to trial twice-yearly HIV antibody dosing after Phase IIb success
ViiV Healthcare is looking to investigate twice-yearly dosing of its human immunodeficiency virus (HIV) therapy which has been able to suppress viral load in patients dosed every four months in a Phase IIb trial. Results from the company's Embrace trial (NCT05996471) found that 96% of patients dosed with 60mg/kg N6LS (VH109) intravenously (IV), were able to maintain HIV-1 RNA levels below 50 copies per ml in blood, compared to 96% in the standard-of-care (SoC) group, who received antiretroviral therapies (ART). At the same time, 88% of another group receiving 3000mg of N6LS subcutaneously alongside recombinant human hyaluronidase (rHuPH20), were also able to achieve the same effect, maintaining viral load below detectable levels. N6LS was administered in both arms every four months, combined with monthly cabotegravir long-acting injections, in this case using the company's other proprietary HIV regimen, Cabenuva (cabotegravir and rilpivirine). Virologic failure was observed in two patients from each group. Results from the Embrace trial were presented as part of the 2025 Conference on Retroviruses and Opportunistic Infections (CROI) in San Francisco, with the company adding that it plans to advance N6LS to six-monthly IV dosing in combination with Cabenuva as part of the Embrace part two study. Kimberly Smith, head of research & development at ViiV Healthcare, said: 'The Embrace study demonstrated that VH109, a CD4-binding broadly neutralising antibody, administered every four months with cabotegravir, achieved high efficacy and was well tolerated through six months. 'We're looking forward to continuing the development of VH109 as a component of our future ultra-long-acting regimens.' The London-based company is majority-owned by UK pharmaceutical giant GSK with companies such as Pfizer and Shionogi holding minority shares in the company. The Phase IIb multicentre, randomised, open-label study recruited 134 patients at 45 locations across the US. The company describes N6LS as a broadly neutralising antibody (bNAbs), a type of antibody that can recognise and block the entry of a broad range of different strains of HIV into healthy cells. The trial secondary endpoint examining the number of AEs found that 64% of the IV group and 65% of the subcutaneous group experienced some form of treatment-related AE. 16% of patients in the subcutaneous group experienced grade 3 and 4 erythema. Infusion site reactions were reported in no IV patients, but 14% of patients in the subcutaneous group. Research by GlobalData's pharmaceutical research centre details that should N6LS make it to market, it is estimated to bring in $41m for ViiV Healthcare, with that figure expected to rise to $247m by the end of 2031. GlobalData is the parent company of Clinical Trials Arena. Elsewhere in the world of HIV therapies, Gilead is set to launch a Phase III trial of its once-yearly lenacapavir pre-exposure prophylaxis (PrEP) for the disease. Meanwhile, massive cutbacks in USAID funding is set to have ramifications on international research in diseases such as HIV. "ViiV to trial twice-yearly HIV antibody dosing after Phase IIb success" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Yahoo
13-03-2025
- Health
- Yahoo
ViiV Healthcare announces new implementation study data showing zero cases of HIV with Apretude, the only long-acting injectable approved for HIV PrEP
New data at CROI 2025 show zero cases of HIV acquisition reported with Apretude (cabotegravir long-acting (CAB LA) for PrEP) in varied clinical settings and populations in two implementation studies in the U.S. and Brazil Data for Cabenuva (cabotegravir + rilpivirine long-acting (CAB+RPV LA)), the only complete long-acting injectable approved for HIV treatment, show high effectiveness in two, large real-world studies LONDON, March 12, 2025--(BUSINESS WIRE)--ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced new data from two implementation studies showing zero cases of HIV acquisition for Apretude, the only long-acting injectable approved for HIV prevention. Real-world data were also presented for Cabenuva, the only approved, complete long-acting injectable treatment regimen, showing its effectiveness in the three years since it has been available. These data were presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2025), in San Francisco, U.S. Harmony P. Garges, M.D. MPH., Chief Medical Officer at ViiV Healthcare, said: "As the leaders in long-acting injectables for HIV, we're committed to collecting data to understand the effectiveness of these first-in-class medicines in real-world settings. Our ongoing, real-world and implementation studies for Apretude show effectiveness of HIV prevention of more than 99% in nearly 4,000 people; and we have real-world experience in more than 15,000 people receiving Cabenuva for HIV treatment showing continued high effectiveness up to two years. Our data at CROI 2025 reinforce that, across a broad range of settings and populations, our long-acting injectables provide a highly effective option for both HIV treatment and prevention, that remove the need for daily pills." Ricky Hsu, M.D., Department of Medicine, NYU Grossman School of Medicine and Medical Director, AHF Healthcare Center, said: "While randomised clinical trials are the gold standard for testing the safety and efficacy of medicines, real-world evidence can provide a fuller understanding of the safety and effectiveness of a therapy over time. Since ViiV Healthcare's introduction of long-acting injectables, generating these valuable insights is more important than ever to help providers decide who could benefit from particular medicines and better understand how they address the everyday needs of people impacted by HIV." Highlights from ViiV Healthcare and partner real-world and implementation studies for long-acting injectables Apretude (prevention) and Cabenuva (treatment): PILLAR 12-month clinical results: zero HIV acquisition and high persistence with CAB LA for PrEP1 New 12-month findings from the PILLAR study explore effectiveness, diagnostic testing, persistence (time that an individual continued to receive injections), safety and tolerability of CAB LA in 201 participants. PILLAR is a phase IV implementation trial assessing the integration of CAB LA for PrEP across 17 clinics in the U.S. among a diverse population of men who have sex with men and transgender men, 26% of whom were Black and 38% Hispanic/Latino. No cases of HIV acquisition were observed through 12 months. Persistence on CAB LA was high, at 85% (n=171/201) at six months and 72% (n=142/196) at 12 months; excluding five participants who completed the study post-data cutoff. Five participants missed an injection and received either oral CAB or alternative PrEP. Adverse events (AEs) related to CAB LA were uncommon, with injection site pain the most frequently reported (3%, n=6). Five percent of participants (n=11) had AEs leading to discontinuation, most commonly due to injection site pain. These implementation study data - obtained from a diverse population - support CAB LA as an effective PrEP option associated with high persistence. ImPrEP CAB Brazil implementation study data shows significantly improved PrEP coverage and protection with CAB LA2 The ImPrEP CAB Brazil study (The Choice Cohort) assessed PrEP coverage and HIV incidence among 1,447 participants who were given the choice of CAB LA or oral PrEP (TDF/FTC) for HIV prevention. The Choice Cohort included PrEP-naïve, cisgender men who have sex with men, non-binary and trans people aged 18 to 30. As a comparison group, the study assessed 2,263 people of a similar demographic, initiating oral PrEP through the Brazilian public health system during the same period. The results show that offering CAB LA injections significantly improved PrEP coverage and HIV prevention for young key populations, reinforcing the role of CAB LA in addressing adherence challenges some people face with oral PrEP. Eighty-three percent of the 1,447 participants who were free to choose either CAB LA or oral PrEP chose CAB LA (1,200 participants) and there were zero HIV acquisitions reported over 798.4 person-years in The Choice Cohort. There were eight HIV acquisitions over 408.52 person-years reported in the comparison group (incidence rate 1.96 [95% CI 0.98-3.92] per 100 person-years). The proportion of individuals covered by PrEP during follow-up was highest in the CAB LA group (96.2%, 221,273/229,951 days), followed by the oral PrEP group within The Choice Cohort (64.1%, 32,272/50,310 days) and lowest in the comparison group (47.4%, 191,765/404,781 days). The study is sponsored by the Evandro Chagas National Institute of Infectious Diseases at the Oswaldo Cruz Foundation, Brazil, and funded by Unitaid. Real-world data from OPERA show high effectiveness of CAB+RPV LA in broad populations3,4 The first of two OPERA analyses looked at long-term effectiveness in diverse virologically suppressed individuals on CAB+RPV LA - 42% of whom are Black and 30% Hispanic - through two years. In this large (n=2,485) U.S. cohort of individuals who switched to CAB+RPV LA, with a median follow-up time of 11 months (IQR: 6-18), 95% maintained virological suppression (<50c/ml at last Viral Load (VL)) and 1% (n=21) experienced confirmed virologic failure (CVF) after a median of seven months. Outcomes were consistent over time through 24 months and across BMI categories (<30 kg/m2, ≥30 kg/m2).3 In a second analysis among a diverse group of 381 virologically suppressed women with HIV, with a median follow-up time of 12 months (IQR:7-19), 94% maintained suppression at their last viral load and CVF was ≤1.3% (n≤5).4 High rates of viral suppression observed in Trio Health cohort5 The Trio Health cohort followed 928 virologically suppressed individuals initiating CAB+RPV LA in real-world settings in the U.S. The median (IQR) follow-up time after the first injection was 12 months (5-19) and 89% of injections (6176/6934) were administered without delay (<7 days after the target dosing date). Ninety-five percent of individuals on CAB+RPV LA maintained viral suppression (last VL <50 c/mL) and 1.6% (n=15) experienced CVF. These studies add to the real-world evidence supporting CAB+RPV LA's high effectiveness in a broad range of populations. About Apretude Apretude is a medicine used for preventing sexually transmitted HIV-1 infection (pre-exposure prophylaxis or PrEP) in adults and adolescents weighing at least 35kg who are at high risk of being infected. 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. It should be used in combination with safer sex practices, such as using condoms. Apretude contains the active substance cabotegravir. Please consult the full Prescribing Information. About Cabenuva (cabotegravir + rilpivirine) Cabenuva is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years and older and weighing at least 35kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 c/ml) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. 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 Unlimited Company. Rilpivirine tablets are approved in the U.S. and when used with cabotegravir is indicated for short-term treatment of HIV-1 infection in adults and adolescents 12 years and older and weighing at least 35kg who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. INSTIs 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 disease. Rilpivirine is an NNRTI that works by interfering with an enzyme called reverse transcriptase, which stops the virus from multiplying. Please consult the full Prescribing Information. Trademarks are owned by or licensed to the ViiV Healthcare group of companies. About ViiV Healthcare ViiV Healthcare is a global specialist HIV company established in November 2009 by GSK (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who could benefit from prevention. Shionogi became a ViiV shareholder 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 About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at 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 under Item 3.D "Risk factors" in GSK's Annual Report on Form 20-F for 2024. Registered in England & Wales: GSK plc ViiV Healthcare Limited No. 3888792 No. 06876960 Registered Office: 79 New Oxford Street ViiV Healthcare Limited London GSK Medicines Research Centre WC1A 1DG Gunnels Wood Road, Stevenage United Kingdom SG1 2NY References 1 T Khan, et al. PILLAR 12 Month Clinical Results: Zero HIV acquisition and High Persistance with CAB LA for PrEP. Presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2025), 9-12 March, San Francisco, CA2 B Grinsztejn et al. ImPrEP CAB Brasil: Enhancing PrEP coverage with CAB LA in Young Key Populations. Presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2025), 9-12 March, San Francisco, CA3 Sension M, et al. Long-term CAB+RPV LA Effectiveness in Virologically Suppressed Individuals in the OPERA Cohort. Presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2025), 9-12 March, San Francisco, CA4 Altamirano J, et al. Clinical outcomes Among Virologically Suppressed Women Receiving CAB+RPV LA in the OPERA Cohort. Presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2025), 9-12 March, San Francisco, CA5 Sax P, et al. Outcomes on Cabotegravir + Rilpivirine in Suppressed People with HIV (PWH) in TRIO Health US Cohort. Presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2025), 9-12 March, San Francisco, CA View source version on Contacts ViiV Healthcare enquiries:Media:Rachel Jaikaran +44 (0) 78 2352 3755 (London)Melinda Stubbee +1 919 491 0831 (North Carolina)GSK enquiries:Media:Tim Foley +44 (0) 20 8047 5502 (London)Sarah Clements +44 (0) 20 8047 5502 (London)Kathleen Quinn +1 202 603 5003 (Washington DC)Alison Hunt +1 540 742 3391 (Washington DC)Investor Relations:Annabel Brownrigg-Gleeson +44 (0) 7901 101944 (London)James Dodwell +44 (0) 20 8047 2406 (London)Mick Readey +44 (0) 7990 339653 (London)Camilla Campbell +44 (0) 7803 050238 (London)Steph Mountifield +44 (0) 7796 707505 (London)Jeff McLaughlin +1 215 751 7002 (Philadelphia)Frannie DeFranco +1 215 751 4855 (Philadelphia)
