Rifampicin

ViiV Healthcare Showcases Long-Acting HIV Innovations and Pipeline Advances at CROI 2025

2 months ago

• Real-world data presented at CROI 2025 demonstrates zero HIV acquisitions and high persistence with Apretude (cabotegravir LA) for PrEP across diverse populations, reinforcing its effectiveness in HIV prevention. • Long-term follow-up data from multiple studies confirms the sustained efficacy and safety of Cabenuva (cabotegravir + rilpivirine LA) as a complete treatment regimen for people living with HIV. • Late-breaking phase IIb data reveals promising results for an investigational broadly neutralizing antibody (VH3810109) in combination with cabotegravir LA, potentially expanding long-acting treatment options.

Shorter, All-Oral Regimens Show Promise for Rifampin-Resistant Tuberculosis

4 months ago

• A phase 3 clinical trial, endTB, has identified three new 9-month, all-oral drug regimens as effective alternatives to the standard 18-24 month treatment for rifampin-resistant tuberculosis. • The new regimens, combining drugs like bedaquiline and delamanid, demonstrated favorable outcomes in 85% to 90% of participants, comparable to the 81% success rate of the control group. • These shorter, less toxic regimens have been endorsed by the WHO and offer improved accessibility and affordability, with some costing less than $500, potentially transforming TB treatment. • The study included diverse populations, such as children, pregnant women, and individuals with HIV or hepatitis C, often excluded from clinical trials, making the findings broadly applicable.

United Therapeutics to Present Clinical Data on Tyvaso DPI at PVRI 2025 Annual Congress

4 months ago

United Therapeutics Corporation announced the presentation of five posters at the Pulmonary Vascular Research Institute (PVRI) 2025 Annual Congress, highlighting clinical data on Tyvaso DPI for pulmonary hypertension. The event will also feature speaking engagements and sponsored luncheons aimed at fostering professional development and networking within the pulmonary hypertension community.

New 4-Month TB Treatment Regimen Shows Effectiveness Comparable to Standard 6-Month Regimen

4 months ago

A new 4-month tuberculosis (TB) treatment regimen, involving high-dose daily rifapentine with moxifloxacin, isoniazid, and pyrazinamide, has been found to be as effective as the standard 6-month regimen for curing drug-susceptible TB disease. This regimen is recommended for individuals aged 12 and older with a body weight of at least 40 kg, who have pulmonary TB caused by organisms not known or suspected to be drug-resistant, and who have no contraindications to this regimen.

Gilead's Livdelzi Shows Sustained Efficacy and Long-Term Safety in Primary Biliary Cholangitis

6 months ago

• Interim analysis of the Phase 3 ASSURE study showed that 81% of participants with PBC achieved a composite biochemical response after two and a half years of Livdelzi treatment. • 41% of participants achieved normalization of alkaline phosphatase (ALP) levels, a key indicator of liver function, highlighting the drug's potential in managing PBC. • Livdelzi demonstrated a reduction in pruritus severity, with nearly resolution of itch in 27% of participants with moderate to severe itch, improving quality of life. • Long-term safety data indicated that Livdelzi was generally well-tolerated, with no treatment-related serious adverse events reported, supporting its use as a durable treatment option.

FDA Approves ROXYBOND™ 10 mg for Pain Management with Abuse-Deterrent Technology

7 months ago

• The FDA has approved ROXYBOND™ (oxycodone hydrochloride) 10 mg immediate-release tablets from Protega Pharmaceuticals for managing severe pain. • ROXYBOND™ features SentryBond™ technology, designed to deter abuse through physical and chemical manipulation, addressing a critical unmet need. • Clinical data suggests ROXYBOND™ reduces abuse potential via intranasal and intravenous routes, offering clinicians a new tool for responsible opioid therapy. • Protega plans to launch ROXYBOND™ 10 mg soon, adding to the existing 5 mg, 15 mg, and 30 mg tablets, enhancing dosing flexibility for patients.

Global TB Crisis Persists: CHEST 2024 Leaders Highlight Post-COVID Challenges and Rising Death Toll

7 months ago

• Tuberculosis remains the second leading infectious killer globally after COVID-19, with death toll rising from 1.4 million in 2019 to 1.6 million in 2021 due to pandemic-related disruptions. • The disease burden is heavily concentrated in low- and middle-income countries, with 87% of cases occurring in 30 high-burden nations, particularly in South-East Asia, Africa, and Western Pacific regions. • Medical experts at CHEST 2024 warn of significant TB underdiagnosis during the COVID-19 pandemic and emphasize the need for continued vigilance, especially in regions where the disease remains prevalent.

Ezetimibe and Rifampin Combination Significantly Increases Coproporphyrin Levels, Impacting Drug Interaction Assessments

7 months ago

• A recent study reveals that ezetimibe monotherapy increases serum coproporphyrin I (CPI) concentrations in healthy individuals, potentially affecting OATP1B1 function. • Co-administration of ezetimibe and rifampin further elevates CPI levels, complicating the assessment of drug interactions in patients undergoing combination therapies. • The research supports CPI as a reliable biomarker for monitoring OATP1B1 activity, crucial for personalized medicine approaches and reducing adverse drug reactions. • Ezetimibe-glucuronide, a metabolite of ezetimibe, significantly reduces cellular CPI accumulation, suggesting a broader role in modulating transporter function beyond cholesterol reduction.

Nose-to-Brain Drug Delivery Shows Promise for Treating Central Nervous System Tuberculosis

7 months ago

• Indian scientists have developed a novel nose-to-brain drug delivery method for treating Central Nervous System Tuberculosis (CNS-TB), a severe form of the disease. • The method utilizes chitosan nano-aggregates to transport TB drugs directly to the brain, bypassing the blood-brain barrier and improving drug bioavailability. • In mice studies, nasal delivery of nano-aggregates significantly reduced bacteria in the brain compared to untreated subjects, demonstrating therapeutic effectiveness. • This approach could potentially be applied to treat other brain infections, neurodegenerative diseases, brain tumors, and epilepsy by enabling efficient drug delivery.

FDA Updates: Approvals for RSV Vaccine, Pneumococcal Vaccine, and TB Drug Alongside Device Recalls

8 months ago

• The FDA granted traditional approval to Sirturo (bedaquiline) for treating rifampin- and isoniazid-resistant tuberculosis in adults and children, based on Phase 3 STREAM study data. • mResvia, an mRNA-based vaccine, received FDA approval for preventing lower respiratory tract disease caused by respiratory syncytial virus (RSV) in adults aged 60 years and older. • Capvaxive, a pneumococcal 21-valent conjugate vaccine, was approved for preventing invasive disease and pneumonia caused by Streptococcus pneumoniae in adults 18 years and older. • Several critical care medical devices, including infusion pumps and chest compression devices, were recalled due to potential for serious adverse health consequences.

Clinical Trial Shows Promise for Maralixibat in Treating ALGS-Related Cholestatic Pruritus

8 months ago

A phase IIb clinical trial, ICONIC, evaluated the safety and efficacy of maralixibat in children with Alagille Syndrome (ALGS), showing significant improvements in serum bile acid (sBA) levels and pruritus severity. The study, involving 31 patients aged 1 to 18 years, demonstrated maralixibat's potential as a treatment for cholestatic pruritus in ALGS patients, with notable reductions in sBA and improvements in quality of life measures.

Drug Development Updates