Objective: To evaluate the efficacy and safety of bictegravir/lenacapavir for the treatment of HIV-1 infection. Data Sources: A literature search was conducted in PubMed and Google Scholar (January 2016-August 2026) using the search terms bictegravir and lenacapavir . Other data sources included abstracts presented at recent conferences and the prescribing information. Study Selection and Data Extraction: All English-language studies assessing the efficacy and safety of bictegravir/lenacapavir for the treatment of HIV-1 infection were considered for inclusion. Data Synthesis: Bictegravir is an established second-generation integrase strand transfer inhibitor (INSTI), whereas lenacapavir is a novel capsid inhibitor. Both antiretrovirals are highly active against HIV-1. Bictegravir/lenacapavir 75 mg/50 mg was shown to be safe and effective in two phase 3 clinical trials after switching from complex antiretroviral therapy (ART) or bictegravir/emtricitabine/tenofovir alafenamide. The Food and Drug Administration approved this combination for the treatment of HIV-1 infection in adults who are virologically suppressed on stable ART with no resistance to the individual components. It is available as a single-tablet regimen (STR) taken orally once daily. Relevance to Patient Care and Clinical Practice in Comparison With Existing Drugs: Bictegravir/lenacapvir is the first INSTI-capsid inhibitor 2-drug STR indicated for the treatment of HIV-1 infection. The combination could be useful for patients who want to simplify their regimen and/or those who cannot use a nucleos(t)ide or a non-nucleoside reverse transcriptase inhibitor. It is not active against hepatitis B virus coinfection. Conclusions: Bictegravir/lenacapvir is safe and efficacious as a 2-drug regimen for the treatment of adults with HIV-1 infection.
Objective: This article reviews the published data encompassing the development, pharmacology, efficacy, and safety of remibrutinib, summarizing data from pivotal clinical studies and clinical relevance in the treatment of chronic spontaneous urticaria. Data Sources: A literature review was conducted in PubMed and ClinicalTrials.gov from inception through August 2026, using terms “RHAPSIDO,” “remibrutinib,” “LOU064,” and “chronic spontaneous urticaria.” Articles from reference lists were included to identify potentially relevant literature. Study Selection and Data Extraction: Clinical data and studies were limited to those published in the English language that discussed the safety and efficacy of remibrutinib. Data Synthesis: The pivotal phase III studies REMIX-1 (n = 470) and REMIX-2 (n = 455) met all primary endpoints at week 12, with Urticaria Activity Score over 7 days (UAS7) reductions of −20.02 and −19.41 versus −13.79 and −11.73 with placebo, parallel improvements in itch and hive severity, and complete absence of itch and hives in 31.1% and 27.9% versus 10.5% and 6.5%. Safety was comparable to placebo, with mild mucocutaneous bleeding (mainly petechiae) the only category significantly more frequent. Relevance to Patient Care and Clinical Practice in Comparison to Existing Drugs: As the first approved oral targeted Bruton’s tyrosine kinase (BTK) inhibitor, remibrutinib provides a new therapeutic option in chronic spontaneous urticaria treatment. Clinical practice is improved by the broadened evidence-based management option, which offers an oral pill alternative with no required routine lab monitoring in place of biologic injections. Conclusion: Remibrutinib provides a new treatment option with the ability to control symptoms and improve quality of life for patients with difficult-to-treat chronic spontaneous urticaria.
Background: Malignant lymphoma-associated pain significantly impairs quality of life and is linked to systemic inflammatory responses. This study evaluated the efficacy and safety of combining extended-release tramadol hydrochloride with acetaminophen compared with monotherapy. Objective: This study aimed to evaluate the efficacy and safety of tramadol hydrochloride extended-release tablets in combination with acetaminophen versus monotherapy with either agent in the treatment of malignant lymphoma-related pain, and to investigate the effects of these treatment regimens on peripheral pain mediators and systemic inflammatory cytokines. Methods: A comparative study was conducted involving 165 patients with malignant lymphoma-associated pain (January 2024-December 2025). Patients were assigned to 3 groups: acetaminophen (n = 53), tramadol (n = 55), or combination therapy (n = 57), receiving 28 days of treatment. Primary outcomes included Numerical Rating Scale (NRS) pain scores and analgesic efficacy. Secondary outcomes included peripheral blood pain mediators (substance P [SP], prostaglandin E2 [PGE2], endothelin-1 [ET-1], 5-hydroxytryptamine [5-HT]), inflammatory cytokines (interleukin [IL]-2, IL-4, IL-6, IL-10, tumor necrosis factor- α [TNF- α ] ] , interferon- γ [IFN- γγ ]), and quality of life. Results: The combination group demonstrated significantly greater reductions in NRS scores and superior analgesic efficacy (91.23%) compared with acetaminophen (71.70%) and tramadol (78.18%) groups ( P < 0 . 05 ) . Combination therapy resulted in the greatest reduction of pain mediators (SP, PGE2, ET-1, 5-HT) and significant modulation of cytokines (lower IL-2, IL-6, TNF- α , IFN- γγ ; higher IL-4, IL-10) ( P < 0 . 05 ) . Quality of life improved significantly more in the combination group ( P < 0 . 05 ) . Adverse event incidence was comparable across groups (18.87%-22.81%; P > 0 . 05 ) , indicating favorable clinical safety. Conclusion and Relevance: The combination of tramadol hydrochloride extended-release tablets and acetaminophen provides superior analgesic efficacy and greater improvement in quality of life compared with either monotherapy in the treatment of malignant lymphoma-related pain, and its mechanism is associated with the synergistic downregulation of peripheral pain mediators and modulation of the inflammatory cytokine profile. During the treatment period, the combination regimen did not significantly increase the risk of adverse reactions, demonstrating a favorable benefit-risk ratio. This report is the first to simultaneously confirm, in this patient population, both the clinical efficacy of this combination regimen and its modulatory effects on the systemic pain-inflammation network, thereby providing a strategy for enhanced analgesia in clinical practice. Based on the data from this study, this regimen may serve as an effective option for the short-term management of moderate to severe pain in patients with malignant lymphoma; however, its long-term efficacy and broad applicability require further investigation.
Objective: To review the pharmacology, efficacy, and safety of palopegteriparatide for the treatment of chronic hypoparathyroidism in adults. Data Sources: A literature search was conducted in PubMed from September 2015 to August 2026. All relevant publications, package inserts, and clinical trials with palopegteriparatide were reviewed. Keywords used were: palopegteriparatide, hypoparathyroidism, parathyroid hormone (PTH), TransCon PTH, hypocalcemia, PTH(1-34), clinical trials and quality of life. Data Extraction: All relevant publications, abstracts, package inserts, and clinical trials involving palopegteriparatide were reviewed. Data Synthesis: Palopegteriparatide is a once-daily subcutaneous injection that uses TransCon technology to treat chronic hypoparathyroidism in adults. Palopegteriparatide led to 93% of participants achieving complete independence from conventional therapy (calcium and active vitamin D) in phase 3 trials. Pill burden decreased from 6.7 at baseline to 0.26 at week 52, and the health-related quality of life of participants significantly increased. The mild-to-moderate adverse effects of palopegteriparatide support its overall favorable tolerability profile. Relevance to Patient Care and Clinical Practice in Comparison to Existing Drugs: Palopegteriparatide is a new PTH analog that mimics physiologic PTH exposure, resulting in more stable serum calcium levels and improved renal handling of calcium and phosphate. Conclusion: Palopegteriparatide is the only Food and Drug Administration-approved medication available that addresses PTH deficiency in chronic hypoparathyroidism. It provides a 24-hour continuous release of PTH enabling effective management of PTH insufficiency.
