Phase I/II Study of the Pharmacokinetics and Safety of Long-Acting Injectable Cabotegravir and Rilpivirine in Pregnant and Postpartum Adults With HIV-1

This is a Phase I/II, multicenter, open-label, non-randomized study with four groups to characterize the pharmacokinetics and safety of Cabotegravir (CAB) and Rilpivirine (RPV) long-acting injectable (LA) during pregnancy and postpartum among people with HIV-1 viral suppression and their infants.

Start Date01 May 2025

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

NCT06646562

/ RecruitingPhase 4IIT

Long Acting Cabotegravir Plus Rilpivirine in People Living with HIV-1 Aged ≥ 60 Years for 24 Months.

People Living with HIV-1 (PLHIV) are an important group of patients attending their specialist's and continue growing thanks to efficacy antiretroviral treatment (ART), allowing them to stabilize the HIV-infection and to live a normal life despite the infection. The present study is encouraged to demonstrate that efficacy and security of CAB LA + RPV LA treatment's on this population remains the same compared to younger population of patients. This study also registers some metabolic and hepatic parameters to observe a hypothetical improvement on these parameters, as the population may suffer more comorbidities than younger population and therefore tolerability and convenience gains a huge importance on them. Psychosocial aspects are also very important in these patients as these patients may suffer social stigma, and therefore suffering certain psychological disorders.

Start Date03 Mar 2025

Sponsor / Collaborator

ViiV Healthcare Ltd.

TCTR20250218001

/ RecruitingPhase 3IIT

Changes in sleep quality following a switch of antiretroviral regimen from three to two drugs: A comparative study between dolutegravir and lamivudine (DTG + 3TC) and dolutegravir and rilpivirine (DTG + RPV)

Start Date04 Feb 2025

Sponsor / Collaborator-

100 Clinical Results associated with Rilpivirine Hydrochloride

100 Translational Medicine associated with Rilpivirine Hydrochloride

100 Patents (Medical) associated with Rilpivirine Hydrochloride

2,105

Literatures (Medical) associated with Rilpivirine Hydrochloride

01 Dec 2025·Current HIV/AIDS Reports

Long-Acting Injectable Antiretroviral Therapy for Treatment of Human Immunodeficiency Virus: A Review

Review

Author: Brotherton, Amy L ; Rossi, Michael R ; Beckwith, Curt G ; Sanchez, Martha C ; Johnson, Jennie E

PURPOSE OF REVIEW:

Long-acting injectable (LAI) antiretroviral therapy (ART) for treatment of HIV-1 are approved both as a complete treatment regimen (cabotegravir/rilpivirine) and as an additional treatment option (lenacapavir) for those with multidrug resistant HIV-1. Here, we review the data supporting these approvals, pharmacokinetics, and additional patient populations that many benefit from LAI ART.

RECENT FINDINGS:

Persons with HIV and adherence challenges as well as those in low-and-middle income countries have high rates of adherence and viral suppression with LAI ART. LAI cabotegravir/rilpivirine (CAB/RPV) offers an alternative treatment approach to daily oral ART for people with HIV-1 infection that is associated with high rates of patient satisfaction when compared to daily oral ART. LAI CAB/RPV is currently only approved in those with HIV-1 viral suppression, however recent data support the use of LAI ART in populations with adherence challenges. Furthermore, given high rates of NNRTI resistance globally, CAB/RPV is not recommended in low-and-middle income countries presently, although this recommendation is likely to change based on recently published data. More research is needed among groups that may benefit from long-acting treatments for HIV-1.

01 Jun 2025·ACTA PSYCHOLOGICA

The intention to adopt photovoltaic systems: integrating behavioral theories with mediation-moderation analysis

Article

Author: Hussain, Sajjad ; Rehman, Manzar ; Jun, Yang ; Zelin, Tong ; Hussain, Talib

The swift advancement of photovoltaic (PV) technology, coupled with the increasing emphasis on sustainable energy solutions, has generated interest in understanding the factors that influence consumers' choices to purchase PV systems. This research aims to identify key areas where the intention to acquire photovoltaic systems might be improved. The purchasing intention of Photovoltaic systems is influenced by various individual theories, including the Theory of Planned Behavior, the Model of Technology Acceptance (TAM), and the Theory of the Diffusion of Innovations (DOI). The data we collected came from an online survey that was distributed in May 2024 to a cohort of 1200 persons who are members of a paid panel managed by Credamo.com. The eligible participants were limited to individuals who owned homes in China and did not have solar panels. We use Amos and SPSS for data analysis. We choose China since it is one of the major RPV marketplaces globally, offering numerous purchasing opportunities. Since most of the study on China's adoption of PV systems has been theoretical and not cumulative, an additional purpose is to establish a foundation for future research endeavors. The present study introduces a comprehensive framework that aims to explain consumer interest in residential photovoltaics by incorporating aspects from Technology Acceptance Model, Theory of Planned Behavior, and Diffusion of Innovation. The study results demonstrate a robust and favorable impact of the Theory of Planned Behavior, the Technological Acceptance Model, and the Diffusion of Innovations on the intention to purchase photovoltaic systems. As anticipated by the DOI (Diffusion of Innovation) theory, the findings indicate that the innovativeness of DOI is positively associated with the inclination to engage in discussions about a potential purchase of a photovoltaic (PV) system. The results indicate that both the total effect and direct effect are statistically significant (S.E: 0.276, P: 0.000) accounting for 34 % of the overall contribution. Consumer novelty seeking had a significant beneficial impact on interest and also had favorable indirect impacts through perceived relative advantage. The TPB variables explained 31 % of the variance in interest, taking into account household limitations. The inclusion of social curiosity in the model revealed that the belief in the personal benefits of solar panels had the most powerful direct and overall impact on interest. This was demonstrated by the significant (S.E: 0.313, P: 0.000) direct and total effect on the intention to purchase a PV system for household use. The analytical findings demonstrate a direct and favorable relationship between the Technology Acceptance Model, also known as the TAM, and the intention to acquire photovoltaic (PV) systems in China. The findings demonstrate a 35 % variation and emphasize the significance (S.E: 0.070, P: 0.000) of improving the perceived simplicity of use and perceived usefulness of PV systems in order to encourage customer adoption.

01 Jun 2025·AIDS

Antiretroviral therapy in people with HIV and end-stage kidney disease

Article

Author: Post, Frank A. ; Pieri, Christopher ; Popoola, Joyce ; Hamzah, Lisa ; Jones, Rachael ; Booth, John ; Shah, Sapna ; Murphy, Maurice ; Spencer, Matthew ; Levy, Jeremy

Objective::

To summarize antiretroviral therapy (ART) use in the setting of end-stage kidney disease (ESKD).

Design::

Cross-sectional analysis.

Methods::

Descriptive analysis of ART regimens and dose of nucleoside/nucleotide reverse-transcriptase inhibitors (NRTI) in people with HIV and ESKD [dialysis, kidney transplantation, or estimated glomerular filtration rate (eGFR) <15 ml/min/1.73 m2] receiving HIV and renal care at five London centres. Exposures of interest were use of dual/unboosted ART regimens and higher than recommended doses of renally cleared NRTI.

Results::

A total of 157 participants were included (median age 55 years, 66% men, 84% black ethnicity, median CD4+ cell count 382 cells/μl, 99% HIV RNA <200 copies/ml). Fifty-eight (37%) were on dual/unboosted ART regimens, mainly dolutegravir/lamivudine. Participants on dual/unboosted ART had similar rates of HIV suppression as those on triple ART. Two participants currently virologically controlled on triple-ART had previously failed to suppress on dual/unboosted ART [dolutegravir/rilpivirine and dolutegravir/lamivudine (50 mg)]. Lamivudine doses were higher than recommended in 75 (77%) and lower than recommended in 8 (8%) participants. Full-dose lamivudine (300 mg daily) was used by 24 (32%) participants with eGFR less than 30 ml/min/1.73m2. None of those currently on reduced-dose lamivudine had required dose reductions for previous toxicity concerns.

Conclusion::

Dual/unboosted ART regimens, such as dolutegravir/lamivudine, provide robust viral efficacy in the setting of ESKD, and higher than recommended, including full-dose, lamivudine was well tolerated. The dolutegravir/lamivudine (300 mg) fixed-dose combination provides a single-tablet regimen for use across the eGFR spectrum, avoids under-exposure to lamivudine, and merits further evaluation in this population.

115

News (Medical) associated with Rilpivirine Hydrochloride

28 Apr 2025

·www.globenewswire.com

Phathom Pharmaceuticals to Present VOQUEZNA® (vonoprazan) Data at DDW 2025 Annual Meeting

New data includes real-world analyses of VOQUEZNA-treated patients in the U.S. diagnosed with gastroesophageal reflux disease (GERD) FLORHAM PARK, N.J., April 28, 2025 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, today announced that the company will present real-world data for its first-in-class treatment VOQUEZNA® (vonoprazan) at Digestive Disease Week® (DDW) being held May 3–6, 2025, in San Diego, CA. VOQUEZNA is the first and only treatment of its kind approved by the U.S. Food and Drug Administration for use in adults for the relief of heartburn associated with Non-Erosive GERD and for the treatment of all severities of Erosive Esophagitis (EE), commonly referred to as Erosive GERD, and relief of related heartburn. Two Phathom-sponsored posters will be presented on May 5, 2025, at 12:30 p.m. PT in the Poster Hall at the San Diego Convention Center. In addition, Phathom will host a Product Theater highlighting VOQUEZNA as a first-in-class treatment for GERD and will maintain a strong presence throughout the conference at booth #1743 on the exhibit floor. “Millions of GERD patients continue to experience inadequate symptom control despite treatment with proton pump inhibitors (PPIs),” said Eckhard Leifke, M.D., Chief Medical Officer at Phathom. “The data we’re presenting at DDW this year analyze real-world treatment patterns and patient characteristics, offering valuable insights into how VOQUEZNA is being used in clinical practice. These findings suggest VOQUEZNA may play an important role for patients who have not achieved sufficient relief with existing therapies and reinforce Phathom’s commitment to advancing the understanding and management of acid-related GI diseases. We look forward to engaging with healthcare professionals and thought leaders at DDW to further discuss the evolving treatment landscape.” A high-level schedule of Phathom-sponsored activities at DDW 2025 can be found below: Sunday, May 4, 2025 VOQUEZNA® (vonoprazan) Product Theater: Expert Insights on GERD Therapy: A Case-Based Approach with a First-In-Class Acid Suppressant Time: 12:15 – 1:00 pm PTPresenters: Dr. John Erik Pandolfino and Dr. Felice Schnoll-SussmanLocation: DDW Theater 1 Independent Medscape CME Symposia: Clinical Decisions in the Management of GERD: A Patient Simulation Challenge Time: 6:00 – 7:30 pm PTPresenters: Dr. Charles Vega, Dr. Prakesh Gyawali and Dr. Rena YadlapatiIndependent CME sponsored by Phathom Pharmaceuticals Monday, May 5, 2025 Tadataka ‘Tachi’ Yamada, MD, Lecture: Pivotal Role of Acid Suppression: PPIs, PCABs and Beyond in Clinical Practice Time: 8:00 – 9:30 am PTAGA Clinical Symposium sponsored by Phathom Pharmaceuticals Real-World Demographic and Clinical Characteristics of Vonoprazan-Treated Patients in the United States Diagnosed With GERD: A Descriptive Analysis of Non-Erosive vs. Erosive GERD Time: 12:30 pm PTPresentation #: Mo1369Poster Session Real-World Treatment Patterns of Prior Lines of PPI Therapy in Vonoprazan-Treated Patients in the United States Diagnosed with Non-Erosive or Erosive GERD Time: 12:30 pm PTPresentation #: Mo1363Poster Session Following the meeting, data abstracts will be available on Phathom’s publications and scientific congresses section of the company website. VOQUEZNA is marketed exclusively by Phathom Pharmaceuticals, Inc. Please visit VoqueznaPro.com to learn more about VOQUEZNA. About DDWDigestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW is an in-person and online meeting from May 3-6, 2025. The meeting showcases more than 5,600 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org. INDICATIONS AND USAGE VOQUEZNA® (vonoprazan) is a potassium-competitive acid blocker (PCAB) indicated in adults: for the healing of all grades of Erosive Esophagitis (Erosive Gastroesophageal Reflux Disease or Erosive GERD) and relief of heartburn associated with Erosive GERD.to maintain healing of all grades of Erosive GERD and relief of heartburn associated with Erosive GERD.for the relief of heartburn associated with Non-Erosive GERD.in combination with amoxicillin and clarithromycin for the treatment of Helicobacter pylori (H. pylori) infection.in combination with amoxicillin for the treatment of H. pylori infection. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS VOQUEZNA is contraindicated in patients with a known hypersensitivity to vonoprazan or any component of VOQUEZNA, or in patients receiving rilpivirine-containing products. For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with VOQUEZNA, refer to the Contraindications section of the corresponding prescribing information. WARNINGS AND PRECAUTIONS Presence of Gastric Malignancy: In adults, symptomatic response to therapy with VOQUEZNA does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing in patients who have a suboptimal response or an early symptomatic relapse after completing treatment with VOQUEZNA. In older patients, also consider endoscopy. Acute Tubulointerstitial Nephritis: Acute tubulointerstitial nephritis (TIN) has been reported with VOQUEZNA. If suspected, discontinue VOQUEZNA and evaluate patients with suspected acute TIN. Clostridioides difficile-Associated Diarrhea: Published observational studies suggest that proton pump inhibitors (PPIs) may be associated with an increased risk of Clostridioides difficile-associated diarrhea (CDAD), especially in hospitalized patients. VOQUEZNA may also increase the risk of CDAD. Consider CDAD in patients with diarrhea that does not improve. Use the shortest duration of VOQUEZNA appropriate to the condition being treated. CDAD has been reported with use of nearly all antibacterial agents. For more information specific to antibacterial agents (clarithromycin and amoxicillin) indicated for use in combination with VOQUEZNA, refer to Warnings and Precautions section of the corresponding prescribing information. Bone Fracture: Several published observational studies suggest that PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine, especially in patients receiving high dose (multiple daily doses) and long-term therapy (a year or longer). Bone fracture, including osteoporosis-related fracture, has also been reported with vonoprazan. Use the shortest duration of VOQUEZNA appropriate to the condition being treated. Patients at risk for osteoporosis-related fractures should be managed according to the established treatment guidelines. Severe Cutaneous Adverse Reactions (SCAR): Severe cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with VOQUEZNA. Discontinue VOQUEZNA at the first signs or symptoms of SCAR or other signs of hypersensitivity and consider further evaluation. Vitamin B12 (Cobalamin) Deficiency: Long-term use of acid-suppressing drugs can lead to malabsorption of Vitamin B12 caused by hypo- or achlorhydria. Vitamin B12 deficiency has been reported postmarketing with vonoprazan. If clinical symptoms consistent with vitamin B12 deficiency are observed in patients treated with VOQUEZNA, consider further workup. Hypomagnesemia and Mineral Metabolism: Hypomagnesemia has been reported postmarketing with vonoprazan. Hypomagnesemia may lead to hypocalcemia and/or hypokalemia and may exacerbate underlying hypocalcemia in at-risk patients. Consider monitoring magnesium levels prior to initiation of VOQUEZNA and periodically in patients expected to be on prolonged treatment, in patients taking drugs that may have increased toxicity in the presence of hypomagnesemia or drugs that may cause hypomagnesemia. Treatment of hypomagnesemia may require magnesium replacement and discontinuation of VOQUEZNA. Consider monitoring magnesium and calcium levels prior to initiation of VOQUEZNA and periodically while on treatment in patients with a preexisting risk of hypocalcemia. Supplement with magnesium and/or calcium, as necessary. If hypocalcemia is refractory to treatment, consider discontinuing VOQUEZNA. Interactions with Diagnostic Investigations for Neuroendocrine Tumors: Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acidity. The increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumors. Temporarily discontinue VOQUEZNA treatment at least 4 weeks before assessing CgA levels and consider repeating the test if initial CgA levels are high. Fundic Gland Polyps: Use of VOQUEZNA is associated with a risk of fundic gland polyps that increases with long-term use, especially beyond one year. Fundic gland polyps have been reported with vonoprazan in clinical trials and during postmarketing use with PPIs. Most patients who developed fundic gland polyps were asymptomatic and fundic gland polyps were identified incidentally on endoscopy. Use the shortest duration of VOQUEZNA appropriate to the condition being treated. ADVERSE REACTIONS: Healing of Erosive GERD: The most common adverse reactions (≥2% of patients in the VOQUEZNA arm) include gastritis (3%), diarrhea (2%), abdominal distention (2%), abdominal pain (2%), and nausea (2%). Maintenance of Healed Erosive GERD: The most common adverse reactions (≥3% of patients in the VOQUEZNA arm) include gastritis (6%), abdominal pain (4%), dyspepsia (4%), hypertension (3%), and urinary tract infection (3%). Relief of Heartburn Associated with Non-Erosive GERD: The most common adverse reactions (≥2% of patients in the VOQUEZNA arm) include abdominal pain (2%), constipation (2%), diarrhea (2%), nausea (2%), and urinary tract infection (2%). Treatment of H. Pylori Infection (VOQUEZNA and Amoxicillin): The most common adverse reactions (≥2% in any treatment arm) include diarrhea (5%), abdominal pain (3%), vulvovaginal candidiasis (2%), nasopharyngitis (2%), dysgeusia (1%), headache (1%), and hypertension (1%). Treatment of H. Pylori Infection (VOQUEZNA, Amoxicillin and Clarithromycin): The most common adverse reactions (≥2% in any treatment arm) include dysgeusia (5%), diarrhea (4%), vulvovaginal candidiasis (3%), headache (3%), abdominal pain (2%), hypertension (2%), and nasopharyngitis (<1%). For more information on adverse reactions and laboratory changes with amoxicillin or clarithromycin, refer to Adverse Reactions section of the corresponding prescribing information. DRUG INTERACTIONS VOQUEZNA has the potential for clinically important drug interactions, including interactions with drugs dependent on gastric pH for absorption, drugs that are substrates for certain CYP enzymes, and some diagnostic tests. Avoid concomitant use of VOQUEZNA with atazanavir or nelfinavir. See full Prescribing Information for more details about important drug interactions. Consult the labeling of concomitantly used drugs to obtain further information about interactions with vonoprazan. For information about drug interactions, contraindications, and warnings and precautions of antibacterial agents (amoxicillin or clarithromycin) indicated in combination with VOQUEZNA, refer to their corresponding prescribing information. USE IN SPECIFIC POPULATIONS Lactation: Breastfeeding is not recommended during treatment. Because of the potential risk of adverse liver effects shown in animal studies with vonoprazan, advise patients not to breastfeed during treatment with VOQUEZNA. Renal Impairment: For the healing of Erosive GERD, dosage reduction is recommended in patients with severe renal impairment (eGFR < 30 mL/min). Use of VOQUEZNA is not recommended for the treatment of H. pylori infection in patients with severe renal impairment. Hepatic Impairment: For the healing of Erosive GERD, dosage reduction is recommended in patients with moderate to severe hepatic impairment (Child-Pugh Class B and C). Use of VOQUEZNA is not recommended for the treatment of H. pylori infection in patients with moderate to severe hepatic impairment. You are encouraged to report suspected adverse reactions by contacting Phathom Pharmaceuticals at 1-888-775-PHAT (7428) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Please click here to see full Prescribing Information for VOQUEZNA. About Gastroesophageal Reflux Disease (GERD) GERD is one of the most prevalent gastrointestinal diseases, with approximately 1 in 5 U.S. adults living with the condition. Depending on the severity, GERD can cause heartburn, regurgitation, difficulty eating and drinking and damage to the esophageal lining. There are two main types of GERD. The largest category of GERD is Non-Erosive GERD, which is characterized by reflux-related symptoms in the absence of esophageal mucosal erosions. It is estimated that approximately 70% of the overall GERD population have Non-Erosive GERD. Symptoms of Non-Erosive GERD may impact overall quality of life and can include episodic heartburn, especially at night, regurgitation, problems swallowing, and chest pain. Erosive GERD, also referred to as Erosive Esophagitis (EE), is a subtype of GERD characterized by erosions in the gastric mucosa caused by acidic reflux of stomach contents into the esophagus. There are estimated to be over 65 million individuals with GERD in the U.S., of which approximately 30% have Erosive GERD. In addition to experiencing troubling symptoms including heartburn, patients with inadequately treated Erosive GERD may progress to more severe diseases including Barrett’s esophagus and esophageal cancer. About VOQUEZNA® VOQUEZNA® (vonoprazan) tablets contain vonoprazan, an oral small molecule potassium-competitive acid blocker (PCAB). PCABs are a novel class of medicines that block acid secretion in the stomach. VOQUEZNA is approved in the U.S. for the treatment of adults with Erosive Esophagitis, also known as Erosive GERD, the relief of heartburn associated with Erosive GERD, the relief of heartburn associated with Non-Erosive GERD, and for the treatment of H. pylori infection in combination with either amoxicillin or amoxicillin and clarithromycin. Phathom in-licensed the U.S. rights to vonoprazan from Takeda, which markets the product in Japan and numerous other countries in Asia and Latin America.  About Phathom Pharmaceuticals, Inc. Phathom Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of novel treatments for gastrointestinal diseases. Phathom has in-licensed the exclusive rights to vonoprazan, a first-in-class potassium-competitive acid blocker (PCAB) that is currently marketed in the United States as VOQUEZNA® (vonoprazan) tablets for the relief of heartburn associated with Non-Erosive GERD in adults, the healing and maintenance of healing of Erosive GERD in adults and relief of associated heartburn, in addition to VOQUEZNA® TRIPLE PAK® (vonoprazan tablets, amoxicillin capsules, clarithromycin tablets) and VOQUEZNA® DUAL PAK® (vonoprazan tablets, amoxicillin capsules) for the treatment of H. pylori infection in adults. For more information about Phathom, visit the company’s website at www.phathompharma.com and follow on LinkedIn and X. Forward Looking StatementThis press release contains forward-looking statements. Investors are cautioned not to place undue reliance on these forward-looking statements, including statements about the possible treatment role that VOQUEZNA plays for GERD patients, Phathom’s plans to continue to engage with healthcare professions regarding treatment options and estimates of the patient populations with GERD. The inclusion of forward-looking statements should not be regarded as a representation by Phathom that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Phathom’s business, including, without limitation: the results of market research regarding real-world usage of VOQUEZNA may not predict acceptance by patients, healthcare providers or payors in the future; we may not be able to successfully commercialize VOQUEZNA, VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK, which will depend on a number of factors including coverage and reimbursement levels from governmental authorities and health insurers as well as market acceptance by healthcare providers; regulatory developments in the United States and foreign countries; unexpected adverse side effects or inadequate efficacy of vonoprazan that may limit its development, regulatory approval and/or commercialization, or may result in recalls or product liability claims; Phathom’s ability to obtain and maintain intellectual property protection and non-patent regulatory exclusivity for vonoprazan; Phathom’s estimates regarding patient population and commercial coverage could prove to be inaccurate; and other risks described in the Company’s prior press releases and the Company’s filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Phathom undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. MEDIA CONTACTNick Benedetto1-877-742-8466media@phathompharma.com INVESTOR CONTACTEric Sciorilli1-877-742-8466ir@phathompharma.com © 2025 Phathom Pharmaceuticals. All rights reserved. VOQUEZNA, VOQUEZNA TRIPLE PAK, VOQUEZNA DUAL PAK, Phathom Pharmaceuticals, and their respective logos are registered trademarks of Phathom Pharmaceuticals, Inc.

Drug ApprovalLicense out/in

31 Mar 2025

·www.globenewswire.com

Actor and Comedian Kenan Thompson Teams Up with Phathom Pharmaceuticals to Raise Awareness About GERD and VOQUEZNA® (vonoprazan)

For the first time, Thompson shares his journey living with gastroesophageal reflux disease (GERD) and experience using VOQUEZNA, as part of the new GERD IS NO JOKE campaignVOQUEZNA is a potassium competitive acid blocker (PCAB), the first and only FDA-approved treatment of its kind for both types of GERD1 A Media Snippet accompanying this announcement is available by clicking on this link. FLORHAM PARK, N.J., March 31, 2025 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, announced today a partnership with actor, comedian, and author Kenan Thompson, best known as the longest-running cast member on Saturday Night Live. For the first time ever, Thompson is publicly speaking out about his experience with GERD as part of the GERD IS NO JOKE campaign to raise awareness about the condition and encourage others to talk with their doctor about treatment options. Thompson, who has been diagnosed with the most common form of GERD, called Non-Erosive GERD, found heartburn relief with VOQUEZNA® (vonoprazan) after struggling with other treatments. VOQUEZNA is the first and only treatment of its kind approved by the U.S. Food and Drug Administration (FDA) to help manage his condition.1 VOQUEZNA is approved for use in adults for the relief of heartburn associated with Non-Erosive GERD and for the treatment of all severities of Erosive Esophagitis, commonly referred to as Erosive GERD, and relief of related heartburn.1 As one of more than 65 million people in the U.S. living with GERD2—a chronic condition where stomach acid flows into the esophagus, causing irritation and heartburn3—Thompson knows firsthand how disruptive symptoms can be. His goal is to help elevate the discussion around GERD and help others recognize the importance of finding an effective treatment to better manage their disease. “This is the first time I’m sharing my story with GERD, and trust me—it's no joke,” said Thompson. “I’ve dealt with terrible burning in my chest, avoided some of my favorite foods, and even had my heartburn affect my voice and sleep, which is tough when your job is to make people laugh. After struggling with treatments that didn’t work, my doctor recommended VOQUEZNA, and it helped me kick some acid and reduce my heartburn! I’m excited to partner with Phathom to encourage others to talk to their doctor and find the right treatment for them.” While Thompson has not experienced side effects while taking VOQUEZNA, some patients taking VOQUEZNA do. The most common side effects of VOQUEZNA for the relief of heartburn related to Non-Erosive GERD include stomach pain, constipation, diarrhea, nausea, and urinary tract infection.1 Please see additional Important Safety Information below. Thompson shares more about his personal story with GERD at GERDIsNoJoke.com, including a downloadable guide from his own unique point of view, and helpful tips for people to talk to their doctor about the condition. “Despite using over-the-counter medications and prescription treatments like antacids, histamine-2 receptor antagonists, or proton pump inhibitors—also called PPIs—many people with GERD continue to experience persistent, bothersome symptoms which could affect their daily lives,” said Kavita Kongara, M.D., Motility Clinical Chair and Georgia Physician Executive Committee Member, United Digestive, Physician, Atlanta Gastroenterology Associates. “It’s crucial that patients engage in open, honest conversations with their healthcare providers to explore all available therapeutic approaches. VOQUEZNA, a first-in-class PCAB, works differently than traditional medications and provides rapid and durable acid suppression, resulting in effective relief from heartburn and making it an important and differentiated option for GERD management.” As part of the campaign, Thompson is also taking on the comedic role of a chef in a “Kick Some Acid Cooking Show," a humorous nod to how VOQUEZNA has helped him better control his GERD-related heartburn. This multi-channel campaign will feature a new commercial airing next month on broadcast television and streaming platforms—including Prime Video, Hulu, and Peacock—and will also extend across digital platforms such as Facebook and Instagram, and in waiting rooms at doctors’ offices. The goal of the light-hearted campaign is to empower individuals experiencing persistent heartburn to consult their healthcare providers. “Phathom is passionate about supporting the millions of patients living with GERD and working to advance innovative treatments to address unmet needs," said Martin Gilligan, Chief Commercial Officer at Phathom. “We are excited to partner with Kenan Thompson, who has been making audiences laugh and feel good for decades. Kenan's story is inspiring and relatable to so many GERD sufferers. By sharing his journey for the first time, he’s helping to spark conversations and encourage others to talk to their doctors about VOQUEZNA.” To learn more about Thompson’s story, tips for discussing GERD with your healthcare provider, and VOQUEZNA as a treatment option, visit GERDIsNoJoke.com. A Media Snippet accompanying this announcement is available by clicking on this link. INDICATION AND IMPORTANT SAFETY INFORMATION What is VOQUEZNA? VOQUEZNA® (vonoprazan) is a prescription medicine used in adults: for 8 weeks to heal acid-related damage to the lining of the esophagus (called Erosive Esophagitis) and for relief of heartburn related to Erosive Esophagitis.for up to 6 months to maintain healing of Erosive Esophagitis and for relief of heartburn related to Erosive Esophagitis.for 4 weeks for relief of heartburn related to gastroesophageal reflux disease (GERD). It is not known if VOQUEZNA is safe and effective in children. Do not take VOQUEZNA if you: are allergic to vonoprazan or any of the other ingredients in VOQUEZNA. Allergic reaction symptoms may include trouble breathing, rash, itching, and swelling of your face, lips, tongue or throat.are taking a medicine that contains rilpivirine (EDURANT, COMPLERA, JULUCA, ODEFSEY) used to treat HIV-1 (Human Immunodeficiency Virus). Before taking VOQUEZNA, tell your healthcare provider about all your medical conditions, including if you: have low magnesium, calcium, or potassium in your blood, or you are taking a medicine to increase urine (diuretic).have kidney or liver problems.are pregnant, think you may be pregnant, or plan to become pregnant. It is not known if VOQUEZNA will harm your unborn baby.are breastfeeding or plan to breastfeed. It is not known if VOQUEZNA passes into your breast milk. You and your healthcare provider should decide if you will take VOQUEZNA or breastfeed. You should not do both. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. VOQUEZNA may affect how other medicines work, and other medicines may affect how VOQUEZNA works. Especially tell your healthcare provider if you take medicine that contains rilpivirine (EDURANT, COMPLERA, JULUCA, ODEFSEY). What are the possible side effects of VOQUEZNA? VOQUEZNA may cause serious side effects including: A type of kidney problem (acute tubulointerstitial nephritis): Some people who take VOQUEZNA may develop a kidney problem called acute tubulointerstitial nephritis. Call your healthcare provider right away if you have a decrease in the amount that you urinate or if you notice blood in your urine.Diarrhea caused by an infection (Clostridioides difficile) in your intestines: Call your healthcare provider right away if you have watery stools, stomach pain, and fever that does not go away.Bone fractures (hip, wrist, or spine): Bone fractures in the hip, wrist, or spine may happen in people who take multiple daily doses of another type of medicine that reduces acid in your stomach known as proton pump inhibitors (PPI medicines) for a long period of time (a year or longer). Tell your healthcare provider if you have a bone fracture, especially in the hip, wrist, or spine.Severe skin reactions: VOQUEZNA can cause rare, but severe skin reactions that may affect any part of your body. These serious skin reactions may need to be treated in a hospital and may be life threatening: Skin rash which may have blistering, peeling, or bleeding on any part of your skin.You may also have fever, chills, body aches, shortness of breath, or enlarged lymph nodes. If you experience any of these symptoms, stop taking VOQUEZNA and call your healthcare provider right away. These symptoms may be the first sign of a severe skin reaction. Low vitamin B-12 levels: VOQUEZNA lowers the amount of acid in your stomach. Stomach acid is needed to absorb Vitamin B12 properly. Tell your healthcare provider if you have symptoms of low vitamin B12 levels, including irregular heartbeat, shortness of breath, lightheadedness, tingling or numbness in the arms or legs, muscle weakness, pale skin, feeling tired, or mood changes. Talk with your healthcare provider about the risk of low vitamin B12 levels if you have been on VOQUEZNA for a long time.Low magnesium levels in the body can happen in people who take VOQUEZNA. Tell your healthcare provider right away if you have symptoms of low magnesium levels, including seizures, dizziness, irregular heartbeat, jitteriness, muscle aches or weakness, or spasms of the hands, feet, or voice.Stomach growths (fundic gland polyps): A certain type of stomach growth called fundic gland polyps may happen in people who take another type of medicine that reduces acid in your stomach known as proton pump inhibitors (PPI medicines) for a long time. Talk with your healthcare provider about the possibility of fundic gland polyps if you have been on VOQUEZNA for a long time. The most common side effects of VOQUEZNA for treatment of Erosive Esophagitis and/or relief of heartburn related to gastroesophageal reflux disease include: • stomach inflammation• indigestion• diarrhea• constipation• stomach bloating• high blood pressure• stomach pain• urinary tract infection• nausea These are not all the possible side effects of VOQUEZNA. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects. You are encouraged to report suspected adverse reactions by contacting Phathom Pharmaceuticals at 1-888-775-PHAT (7428) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Please see Patient Information and full Prescribing Information for VOQUEZNA. About Erosive and Non-Erosive Gastroesophageal Reflux Disease (GERD)Erosive GERD, also referred to as Erosive Esophagitis (EE), is a subtype of gastroesophageal reflux disease (GERD) characterized by erosions in the gastric mucosa caused by acidic reflux of stomach contents into the esophagus.4 There are estimated to be over 65 million individuals with GERD in the U.S.,2 of which approximately 30% have Erosive GERD.3 In addition to experiencing troubling symptoms including heartburn, patients with inadequately treated Erosive GERD may progress to more severe diseases including Barrett’s esophagus and esophageal cancer.5 Non-Erosive GERD is the largest category of GERD and is characterized by reflux-related symptoms in the absence of esophageal mucosal erosions.3 It is estimated that approximately 70% of the overall GERD population have Non-Erosive GERD.3 Symptoms of Non-Erosive GERD may impact overall quality of life and can include episodic heartburn, especially at night, regurgitation, problems swallowing, and chest pain.2,3 About VOQUEZNA®VOQUEZNA® (vonoprazan) tablets contain vonoprazan, an oral small molecule potassium-competitive acid blocker (PCAB). PCABs are a novel class of medicines that block acid secretion in the stomach. VOQUEZNA is approved in the U.S. for the treatment of adults with Erosive Esophagitis, also known as Erosive GERD, the relief of heartburn associated with Erosive GERD, the relief of heartburn associated with Non-Erosive GERD, and for the treatment of H. pylori infection in combination with either amoxicillin or amoxicillin and clarithromycin. Phathom in-licensed the U.S. rights to vonoprazan from Takeda, which markets the product in Japan and numerous other countries in Asia and Latin America. About Phathom Pharmaceuticals, Inc.Phathom Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of novel treatments for gastrointestinal diseases. Phathom has in-licensed the exclusive rights to vonoprazan, a first-in-class potassium-competitive acid blocker (PCAB) that is currently marketed in the United States as VOQUEZNA® (vonoprazan) tablets for the relief of heartburn associated with Non-Erosive GERD in adults, the healing and maintenance of healing of Erosive GERD in adults and relief of associated heartburn, in addition to VOQUEZNA® TRIPLE PAK® (vonoprazan tablets, amoxicillin capsules, clarithromycin tablets) and VOQUEZNA® DUAL PAK® (vonoprazan tablets, amoxicillin capsules) for the treatment of H. pylori infection in adults. For more information about Phathom, visit the company’s website at www.phathompharma.com and follow on LinkedIn and X. Forward-Looking StatementsThis press release contains forward-looking statements. Investors are cautioned not to place undue reliance on these forward-looking statements, including statements about the Company’s estimates of the number of patients with GERD. The inclusion of forward-looking statements should not be regarded as a representation by Phathom that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Phathom’s business, including, without limitation: the Company’s estimates regarding patient population could prove to be inaccurate and other risks described in the Company’s prior press releases and the Company’s filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Phathom undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. References VOQUEZNA. Prescribing Information. Phathom Pharmaceuticals; 2024.Machicado JD, Greer JB, Yadav D. (2021) Epidemiology of Gastrointestinal Diseases. In: Pitchumoni CS, Dharmarajan T, (eds). Geriatric Gastroenterology. Springer, Cham. https://doi.org/10.1007/978-3-030-30192-7_7Antunes C, Aleem A, Curtis SA. Gastroesophageal reflux disease. NCBI Bookshelf. Accessed January 21, 2024. Available at: https://www.ncbi.nlm.nih.gov/books/NBK441938/?report=printableDickman R, Maradey-Romero C, Gingold-Belfer R, Fass R. Unmet Needs in the Treatment of Gastroesophageal Reflux Disease. J Neurogastroenterol Motil. 2015 Jul 30;21(3):309-19. doi: 10.5056/jnm15105. Savarino E, de Bortoli N, De Cassan C, et al. The natural history of gastro-esophageal reflux disease: A comprehensive review. Dis Esophagus. 2017;30(2):1-9. MEDIA CONTACTNick Benedetto1-877-742-8466media@phathompharma.com INVESTOR CONTACTEric Sciorilli1-877-742-8466ir@phathompharma.com © 2025 Phathom Pharmaceuticals. All rights reserved. VOQUEZNA, VOQUEZNA TRIPLE PAK, VOQUEZNA DUAL PAK, Phathom Pharmaceuticals, and their respective logos are registered trademarks of Phathom Pharmaceuticals, Inc. 03/25US-VPZ-24-0652

Drug ApprovalLicense out/in

12 Mar 2025

·www.businesswire.com

ViiV Healthcare announces new implementation study data showing zero cases of HIV with Apretude , the only long-acting injectable approved for HIV PrEP

LONDON--(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 viivhealthcare.com. 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 gsk.com. 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, CA 2 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, CA 3 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, CA 4 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, CA 5 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

Clinical ResultDrug ApprovalPhase 3

100 Deals associated with Rilpivirine Hydrochloride

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KEGG	Wiki	ATC	Drug Bank
D09720 D09958	Rilpivirine Hydrochloride	J05AG05	DB08864

R&D Status

Approved

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Indication	Country/Location	Organization	Date
HIV Infections	United States	Janssen Products LP	20 May 2011

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Pregnancy	Phase 3	United States	Janssen Scientific Affairs LLC	09 Apr 2009
Pregnancy	Phase 3	Puerto Rico	Janssen Scientific Affairs LLC	09 Apr 2009
Hepatitis	Phase 1	United States	ViiV Healthcare Ltd.	01 Nov 2011
Hepatitis C	Phase 1	-	Tibotec Pharmaceuticals	01 Nov 2010
Contraception	Phase 1	-	Tibotec Pharmaceuticals	01 Jul 2008
Contraception Behavior	Phase 1	-	Tibotec Pharmaceuticals	01 Jul 2008
Acquired Immunodeficiency Syndrome	Phase 1	-	Tibotec Pharmaceuticals	01 Jun 2008

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03635788 (LATITUDE , CTgov)	Phase 3	HIV Infections	456	CAB-LA Maintenance Dose+Oral CAB+RPV-LA Loading Dose (Step 2 Arm A: LA ART)	endcjayfdx = friaogkivp tyejdgbvye (pomapsttfn, ohvcsphflc - qawturtgsn) View more	-	24 Apr 2025
				Standard of Care (SOC) Oral ART (Step 2 Arm B: SOC)	endcjayfdx = xifeqyydwd tyejdgbvye (pomapsttfn, bkokxkdkbo - czgpqldidc) View more
NCT03497676 (IMPAACT 2017/MOCHA, Pubmed \| Lancet HIV)	Phase 1/2	-	139	Long-acting Injectable Cabotegravir 600 mg + Long-acting Injectable Rilpivirine 900 mg	ifmgsuilrq(wbkzwxlyrp) = 10.8% [95% CI 6.2-17.2] of all 139 participants in the evaluable analysis population had at least one adverse event of grade 3 or above by week 24 ofhrhhoosb (pmxdkywoba ) View more	Positive	01 Mar 2025
NCT00799864 (PAINT, CTgov)	Phase 2	HIV Infections	54	Rilpivirine (Cohort 1 Adolescents: Rilpivirine 25 mg)	mhqpvsdrdn(cbggjppjug) = xoiatqwovz rlcfddjbid (mjyvxvkcdl, 38.0) View more	-	25 Jun 2024
				Rilpivirine (Cohort 2 Children (>=25 kg): Rilpivirine 25 mg)	mhqpvsdrdn(cbggjppjug) = ykiwzslhpo rlcfddjbid (mjyvxvkcdl, 52.2) View more
NCT04012931 (CTgov)	Phase 2	HIV Infections	26	Rilpivirine (Rilpivirine 12.5 Milligrams (mg) (<20 kg))	lcmxxbvptv(auejbcdcpg) = ojdeciubqa czilkgqvlg (qdzfenkoio, NA) View more	-	02 May 2024
				Rilpivirine (Rilpivirine 15 mg (<20 kg))	pthirhpkcu(rhvgnkdodi) = rrshfgmptq bagjumnvaq (cagchayvvh, NA) View more
TMC278-C213 (FDA) Manual	Phase 2	HIV Infections	-	EDURANT+BR (HIV RNA ≤100,000)	cjbmglsfio(gsqehvrdgf) = nxycefvmik tprupsyywt (tcthwpfpxg ) View more	Superior	15 Mar 2024
				EDURANT+BR (HIV RNA >100,000)	cjbmglsfio(gsqehvrdgf) = etuykrgdvr tprupsyywt (tcthwpfpxg ) View more
NCT00543725 \| NCT00540449 (THRIVE, FDA) Manual	Phase 3	HIV Infections	-	EDURANT + BR	tjeiqvmbjf(frhsljdemc) = ikoskyqwom aocgvjjrdd (tjurveiyrd ) View more	Superior	15 Mar 2024
				Efavirenz + BR	tjeiqvmbjf(frhsljdemc) = xbslsiccfn aocgvjjrdd (tjurveiyrd ) View more
NCT04399551 (CARISEL, CTgov)	Phase 3	HIV Infections	437	Continuous Quality Improvement (CQI) calls	ccacwgrfpv = hykbjsiyhd nlahiydizs (catcqzorif, gkeikijtex - iesgvnqoqc)	-	19 May 2023
NCT04399551 (CARISEL, Corporate Publications) Manual	Phase 3	HIV Infections	437	Cabotegravir+Rilpivirine Hydrochloride	ynzmjjtozz(ilzycbleir) = mcxtkhwlto ndnqafuvhg (wexlnkxfcq ) View more	Positive	24 Oct 2022
NCT03639311 (Pubmed) Manual	Phase 2	HIV Infections	97	CAB+RPV long-acting	jmlfhmvpzg(drbkzjxbzm) = akhmsatbrz ajyyxwlrrq (gvrawjonux ) View more	Positive	01 Feb 2022
				dolutegravir/RPV	jmlfhmvpzg(drbkzjxbzm) = gztaxgqujl ajyyxwlrrq (gvrawjonux ) View more
NCT04001803 (CUSTOMIZE, CTgov)	Phase 3	HIV Infections	115	CAB+RPV LA (Staff Study Participants)	maelqvuuvb(eumuaqgzgj) = bqcpramwum ykzqadnvpb (xskdcrzzlf, 0.42) View more	-	10 Jan 2022
				long-acting (LA)+CAB LA+Rilpivirine (RPV) (Participants With HIV Infection)	vjmbaavucd(iyhgbkkpmp) = yujaiitzfo atkkmadlcm (yqfvkiaesf, 0.74) View more

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