Talicia (amoxicillin/omeprazole/rifabutin) / RedHill - LARVOL DELTA

RedHill Biopharma to Submit FDA-Approved Talicia for UK Marketing Authorisation (PRNewswire) - "RedHill Biopharma Ltd...announced its plan to submit a UK Marketing Authorisation Application (MAA) for Talicia for treatment of helicobacter pylori (H. pylori) infection under the Medicines and Healthcare products Regulatory Agency's (MHRA) International Recognition Procedure (IRP), a fast-track regulatory process for UK drug approvals based on a recognized reference approval. Utilizing the U.S. Food and Drug Administration (FDA) approval of Talicia as reference, potential UK approval could be received as early as the fourth quarter of 2025."

MHRA filing • Infectious Disease

Treatment of Refractory Helicobacter pylori Using Intravenous Doxycycline and Ceftriaxone: A Novel Approach (ACG 2024) - "Previous treatment courses from 2018 to 2023 included Prevpak (amoxicillin, clarithromycin, and lansoprazole), bismuth quadruple therapy (metronidazole, bismuth, tetracycline and omeprazole) yet stool antigen remained positive. Subsequent, treatments included LOAD therapy (levofloxacin, omeprazole, nitazoxanide and doxycycline), Levaquin-based triple therapy (omeprazole, levofloxacin, amoxicillin), and Talicia (omeprazole, amoxicillin, rifabutin)... It is important to consider patient related factors when formulating an effective treatment regimen for patients with H. pylori infection. Our case report demonstrated that intravenous antibiotics offers an alternative treatment option for refractory H. pylori."

CNS Disorders • Epilepsy • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Pain

Treatment Resistant Helicobacter pylori in a Patient with Tuberculosis (ACG 2023) - "Due to documented local resistance to triple therapy, he started quadruple therapy with bismuth subsalicylate, pantoprazole, metronidazole and tetracycline...Following completion of his tuberculosis treatment he started on omeprazole, rifabutin and amoxicillin for H pylori salvage therapy...If the first regimen fails, the second line is using an antibiotic not used in the initial treatment such as, a bismuth quadruple therapy, levofloxacin or clarithromycin containing therapy...There are currently no studies proving an acquired resistance to rifabutin with prior exposure. In this patient despite prior exposure to rifampin, he was successfully treated with a rifabutin based therapy."

Clinical • Infectious Disease • Pain • Pulmonary Disease • Respiratory Diseases • Tuberculosis

PHYSIOLOGICALLY-BASED PHARMACOKINETIC MODELING CONFIRMS RIFABUTIN, AMOXICILLIN, AND OMEPRAZOLE BIOEQUIVALENCE BETWEEN Q8H AND TID DOSING FOR LOW-DOSE RIFABUTIN TRIPLE THERAPY (RHB-105) FOR THE ERADICATION OF HELICOBACTER PYLORI IN ADULT PATIENTS (DDW 2023) - P3 | "The simulated plasma concentration-time profiles and intragastric AUC 312-336h support comparable overall exposures over the last full day of treatment following the two different administration frequencies, as evidenced by overlapping 90% geometric mean intragastric AUC 312-336h confidence intervals (Table 1). When comparing simulated versus observed exposure of drugs, being within 2 fold of observed data is considered to be a primary metric for assessment of model fidelity. For the PBPK modelling of amoxicillin, rifabutin, and omeprazole, predictions were considered to be reasonably accurate as the exposures were within 1.25 fold of the observed data."

Clinical • PK/PD data • Infectious Disease

Physiologically based pharmacokinetic modelling to predict intragastric rifabutin concentrations in the treatment of Helicobacter pylori infection. (PubMed, Aliment Pharmacol Ther) - "PBPK modelling showed rifabutin 50 mg three times daily had higher intragastric exposure times than 150 mg once daily or twice daily, or 300 mg once daily. This low-dose rifabutin regimen provides the highest potential for H. pylori eradication while minimising systemic rifabutin exposure."

Journal • PK/PD data • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Infectious Disease • Oncology • Solid Tumor

"$RDHL RedHill Initiates First Community-Setting Warranty Program to Refund Talicia Non-Responders https://t.co/iGuH4o2qYO" (@stock_titan)

"Recipharm announces extension of commercial manufacturing to support RedHill Biopharma’s Talicia® to 2026 https://t.co/TZLqfOXtO3" (@CisionNews)

Two vonoprazan combinations (Voquezna) for H. pylori. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Infectious Disease

Anaphylactic Reaction to Omeprazole After Negative Pantoprazole Allergy Testing (ACAAI 2022) - "To treat the H. pylori infection, the patient took Talicia (amoxicillin, rifabutin, and omeprazole) and developed generalized pruritus, itchy tongue, throat, and bilateral hand swelling within 20 minutes of taking this medication...The patient was taken to the emergency department and received IV Benadryl (25 mg), famotidine (20 mg), methylprednisolone (125 mg), and intravenous fluids (1L NS), with an improvement in his symptoms...The cross-reactivity between different PPIs is not currently well described, and other PPIs should be avoided unless an SKT and oral drug challenge are performed under close observation. Further studies are needed to provide more information on cross-reactivity among PPIs."

Allergy • Dermatology • Immunology • Infectious Disease • Pain • Pruritus

Modeling Gastric Luminal Rifabutin Concentrations: RHB-105 (Rifabutin 50mg Q8H) Provides More Favorable Exposure for H. pylori Eradication Than Generic Rifabutin 150mg BID or 300mg QD (ACG 2022) - P3 | "RHB-105 is administered as 50mg rifabutin, 1000mg amoxicillin, and 40mg omeprazole, each dosed Q8H for 14 days. Time with gastric luminal concentration above MIC 90 was 16.32±2.25 h for rifabutin 150mg BID (68% of day), and 8.51±1.86 h (35% of the day) for 300mg QD. Although both generic regimens contain twice the daily dose of rifabutin than RHB-105, both failed to achieve the prolonged gastric luminal rifabutin concentration time (22.25±1.08 h; 93% of the day) seen with RHB-105 (50mg Q8H; Figure 1). We previously showed that rifabutin 50mg Q8H (as in RHB-105) maintains gastric luminal concentrations above the MIC 90 nearly 3-times longer than 150mg QD."

Gastric Cancer • Gastroenterology • Gastrointestinal Cancer • Infectious Disease • Oncology • Peptic Ulcer • Solid Tumor

"$RDHL RedHill Presents New Talicia® and Movantik® Data Analyses at ACG 2022 https://t.co/kyn6jK6emN" (@stock_titan)

"Hello is Talicia available in India ? Is there a way i can get it here ?" (@FootballFnatic9)

LOW-DOSE RIFABUTIN TRIPLE THERAPY (RHB-105) MAINTAINS HIGH HELICOBACTER PYLORI ERADICATION RATES AND SHOWS FAVORABLE SAFETY AND EFFICACY IN SUBJECTS WITH DIABETES MELLITUS (DDW 2022) - P3 | "Methods : Data were pooled from two Phase 3 clinical studies (Study 1 NCT01980095/Study 2 NCT03198507) assessing H. pylori eradication with RHB-105 (a combination therapy including low-dose rifabutin (50 mg), 1000 mg amoxicillin, and 40 mg omeprazole)...There were similar rates of resistance between subjects with and without DM for amoxicillin, clarithromycin, metronidazole, and rifabutin (4.0% vs. 7.0%, 21.0% vs. 17.0%, 45.0% vs. 43.0%, and 0% vs. 0%, respectively)...No isolates showed resistance to rifabutin. Since RHB-105 maintains high eradication rates and is well tolerated regardless of DM status, it represents a rational first-line choice for the treatment of H. pylori infection."

Clinical • Diabetes • Infectious Disease • Metabolic Disorders

PHYSIOLOGICALLY-BASED PHARMACOKINETIC MODEL TO ESTIMATE INTRAGASTRIC RIFABUTIN CONCENTRATIONS FOLLOWING RIFABUTIN 50 MG Q8H (RHB-105) OR 150 MG QD: MORE FAVORABLE EXPOSURE FOR HELICOBACTER PYLORI ERADICATON WITH Q8H DOSING (DDW 2022) - P3 | "Treatment with RHB-105 comprises 50 mg rifabutin, 1000 mg amoxicillin, 40 mg omeprazole given Q8H for 14 days. There may be a link between sustained intragastric rifabutin exposure when dosed at 50 mg Q8H and the high eradication rates seen with RHB-105. Dosing rifabutin at 150 mg QD does not replicate the effect of dosing at 50 mg Q8H."

PK/PD data • Infectious Disease

Drugs for GERD and peptic ulcer disease. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Gastroenterology • Gastroesophageal Reflux Disease • Gastrointestinal Disorder • Infectious Disease • Peptic Ulcer

Pitfalls of Physician-Directed Treatment of Helicobacter pylori: Results from Two Phase 3 Clinical Trials and Real-World Prescribing Data. (PubMed, Dig Dis Sci) - P3 | "Rates of CBT use persist despite sub-optimal eradication rates. Since RHB-105 does not contain clarithromycin, it can be prescribed first-line without concerns about clarithromycin resistance or CYP2C19 status. NCT03198507 & NCT01980095."

Clinical • Journal • P3 data • Real-world evidence • Infectious Disease • CYP2C19

In-Person Exhibitor Product Theater - Rethinking First-line Treatment of Helicobacter pylori (ACG 2021) - "This program is sponsored by RedHill Biopharma.It is a promotional program sponsored by RedHill that is designed to educate and inform HCPs and/or Patients about the benefits, risks, and appropriate uses of Talicia, as well as topics that support the day-to-day care of Patients...No CME is provided for Theater presentations. The Exhibitor Product Theater is located in booth 1413 in the Shoreline Exhibit Hall."

Clinical • Infectious Disease

Pitfalls of Physician-Directed Treatment of H. pylori Infection: Results From Two Phase 3 Clinical Trials and Real-World Prescribing Data (ACG 2021) - P3 | "After study NCT03198507, CLR-triple was prescribed for 87% (27/31) of subjects with a cure rate of 59.3%. Following study NCT01980095, CLR-triple was prescribed for 51% (48/94) of subjects with a cure rate of 60.4%. Rapid CYP2C19 metabolizers who received CLR-regimens achieved an eradiation rate of 18.2% (2/11; pooled analysis)."

Clinical • P3 data • Real-world evidence • Infectious Disease • CYP2C19

RHB-105 Q8H Rifabutin Dosing Provides Favorable Exposure for Helicobacter pylori Eradication (ACG 2021) - P3 | "In two phase 3 trials in treatment-naïve subjects, RHB-105 (50 mg rifabutin, 1000 mg amoxicillin, 40 mg omeprazole Q8H for 14 days) demonstrated eradication rates of 89.4% (NCT03198507; modified intention-to-treat) and 83.8% ITT (NCT01980095; 90.3% in confirmed adherent subjects). Predicted plasma PK parameters were consistent with those observed in RHB-105 clinical studies. Based on steady-state simulations, time above MIC90 for RIF was 7.8 ± 2.7 h with 50 mg Q8H and 2.5 ± 1.0 h with 150 mg QD (3.12-fold difference). There was no impact of intragastric pH on predicted gastric lumen concentrations."

Gastrointestinal Disorder • Infectious Disease

"$RDHL $REDIF RedHill Biopharma Presents New Talicia® and Movantik® Data Analyses at ACG 2021 https://t.co/vcP6woMwPz" (@stock_titan)

[VIRTUAL] RedHill Biopharma (BIO 2021) - "RedHill promotes the gastrointestinal drugs Movantik® (OIC), Talicia® (H. pylori) and Aemcolo® (travelers' diarrhea). RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for NTM disease; (ii) opaganib (Yeliva®, ABC294640), a first-in-class SK2 selective inhibitor targeting multiple indications with positive Phase 2 COVID-19 data and an ongoing Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), a serine protease inhibitor in a U.S. Phase 2/3 study as treatment for symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases, as well as additional late-stage asset assets. More information about the Company is available at www.redhillbio.com."

Biliary Cancer • Cholangiocarcinoma • Gastroenterology • Gastrointestinal Cancer • Gastrointestinal Disorder • Genito-urinary Cancer • Infectious Disease • Inflammatory Bowel Disease • Novel Coronavirus Disease • Oncology • Prostate Cancer • Solid Tumor

"Haven't used Talicia! Is it covered by insurance or does it require PA/out of pocket costs? What is success rate so far?" (@GI_PharmD)

Reimbursement

[VIRTUAL] Persistent H. pylori Infection Following Participation in Two Randomized Controlled Trials: Outcomes of Patients Receiving Physician-Directed Standard-of-Care Therapy (ACG 2020) - "RHB-105 is a fixed-dose combination product containing omeprazole, amoxicillin and rifabutin. PD therapy cure rates (mITT analysis) were 61.3% and 56.2% for ERADICATE Hp and ERADICATE Hp2 subjects, respectively. Further details are listed in Table 1. The most frequently prescribed regimens were clarithromycin triple therapy and bismuth quadruple therapy; for both RCTs combined (n=120), these were prescribed for 62.5% and 20.0% of subjects, respectively (Table 2)."

Clinical • Complement-mediated Rare Disorders

"$RDHL RedHill Biopharma Extends Talicia® Unrestricted National and Regional Commercial Coverage to Over 40 Million Additional Americans https://t.co/q2V3a0lsfi" (@stock_titan)

Rifabutin-Based Triple Therapy (RHB-105) for Helicobacter pylori Eradication: A Double-Blind, Randomized, Controlled Trial. (PubMed, Ann Intern Med) - P3 | "RHB-105 (amoxicillin, 3 g; omeprazole, 120 mg; and rifabutin, 150 mg) versus active comparator (amoxicillin, 3 g, and omeprazole, 120 mg), given as 4 capsules every 8 hours for 14 days...Eradication rates were unaffected by resistance to clarithromycin or metronidazole...These findings suggest potential for RHB-105 as first-line empirical H pylori therapy, addressing an unmet need in the current environment of increasing antibiotic resistance. RedHill Biopharma Ltd."

Clinical • Journal • Complement-mediated Rare Disorders • Infectious Disease • Pain