Australian Doctor 18th July 2025 | Page 16

18 JULY 2025 16 NEWS ausdoc. com. au
for your patients aged ≥70 years who test positive for COVID-19 1, 2

18 JULY 2025 16 NEWS ausdoc. com. au

Daily pill for GLP-1 RAs?

Dr Gary Deed.
Mohana Basu ELI Lilly is preparing a TGA application for an oral GLP-1 receptor agonist to treat early diabetes following publication of phase III trial results.
The once-daily pill orforglipron reduced both average HbA1c levels and body weight after 40 weeks, according to the global study published in the New England Journal of Medicine.
The authors said most GLP-1 receptor agonists( RAs) were administered subcutaneously
because of their large molecular weight and peptide structure.
Currently, the only oral version available was a peptide co-formulated with an absorption enhancer.
However, they said both mealtimes and water consumption had to be taken into account when administered to ensure the drug reached therapeutic concentrations.
They said non-peptide, small-molecule GLP-1 RAs, such as orforglipron, had“ the potential to provide higher oral bioavailability
with no dietary requirements and simpler administration”.
The study involved 559 adults with type 2 diabetes who had not used any diabetes medicine in the previous three months and had never used insulin therapy.
All had a baseline HbA1c between 7.0 % and 9.5 % and a BMI of at least 23kg / m 2.
In the placebo-controlled trial, a quarter of participants on orforglipron reached HbA1c levels below 5.7 %, indicating near normoglycaemia.
The researchers said reductions in fasting serum glucose were noticeable as early as four weeks.
“ The once-daily dosing makes it particularly attractive as an option for people living with diabetes not wanting injectable therapy,” Dr Gary Deed, chair of the RACGP’ s Diabetes Specific Interests group, told Australian Doctor.
Eli Lilly was not ready to reveal a potential price, a spokesperson said. N Engl J Med 2025; 21 Jun.

Cancerrisk sperm donor

Reasons to consider LAGEVRIO

for your patients aged ≥70 years who test positive for COVID-19 1, 2

LAGEVRIO must be for use when nirmatrelvir-ritonavir is contraindicated. 1, 2
Proven
In MOVe-OUT, LAGEVRIO reduced the risk for hospitalisation or death vs. placebo through Day 29 by 30 %( adjusted relative risk reduction) in adult patients with mild to moderate COVID-19 4
( 95 % CI: 1 %, 51 %; 6.8 %( 48 / 709 ] vs 9.7 %( 68 / 699). Adjusted risk difference-3.0 %( 95 % CI-5.9 %,-0.1 %), p-value not available). Based on a planned interim analysis of LAGEVRIO vs placebo: The adjusted risk difference was-6.8 %( 95 % CI:-11.3 %,-2.4; 7.3 %( 53 / 377) vs 14.1 %( 28 / 385); p = 0.0024).
Real-world studies, 5-9 including the local Victorian study published in 2023, 5 also support the use of LAGEVRIO in treating older vaccinated patients with mild to moderate COVID-19.
Treatment-related adverse events ≥ 1 %( MOVe-OUT, LAGEVRIO vs placebo): 3 Diarrhoea( 2 % vs 2 %), nausea( 1 % vs 1 %), dizziness( 1 % vs 1 %)
No No to reduce risk of hospitalisation or death 3, 4
known drug interactions based on limited data available 3
dose adjustments required in patients with renal and / or hepatic impairment 3
▼This medicine is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www. tga. gov. au / reporting-problems.
SELECTED SAFETY INFORMATION 3 INDICATION: LAGEVRIO has provisional approval for the treatment of adults with COVID-19 who do not require initiation of oxygen due to COVID-19 and who are at increased risk for hospitalisation or death. The decision to approve this indication was based on efficacy and safety data from a Phase 3 trial. Continued approval of this indication depends on additional data. CONTRAINDICATIONS: Hypersensitivity to the active substance or any of the excipients. Hypersensitivity reactions have been reported with LAGEVRIO. If signs or symptoms of a clinically significant hypersensitivity reaction occur, immediately discontinue LAGEVRIO and initiate appropriate medications and / or supportive care. PRECAUTIONS: Pregnancy Category D: The use of LAGEVRIO is not recommended during pregnancy. In women of childbearing potential, health care providers should discuss the chance that they may be pregnant and consider the need for a pregnancy test. Contraception: Advise women of childbearing potential to use effective contraception for the duration of treatment and for 4 days after the last dose of LAGEVRIO. Sexually active men with a partner of childbearing potential should use contraception during and for 3 months after treatment. Based on animal data, LAGEVRIO may cause foetal harm when administered to pregnant women. Breastfeeding: Based on the potential for adverse reactions on the infant from LAGEVRIO, breastfeeding is not recommended during treatment and for 4 days after the last dose of LAGEVRIO. Paediatric patients: Use in patients under the age of 18 years is not recommended. ADVERSE REACTIONS: Common: nausea, diarrhoea, dizziness. The following have been reported in post-marketing experience: hypersensitivity, angioedema, erythema, pruritus, rash, urticaria, vomiting.
Scan to access study design for registration study 4
PBS information: Authority required( STREAMLINED): LAGEVRIO must be for use when nirmatrelvir(&) ritonavir is contraindicated. 1 The contraindications to nirmatrelvir(&) ritonavir can be found using the Liverpool COVID-19 Drug interaction checker or the TGA-approved Product
1, 10, 11
Information for nirmatrelvir(&) ritonavir. Visit www. pbs. gov. au for more information.
References: 1. Pharmaceutical Benefits Scheme. www. pbs. gov. au( accessed March 2024). 2. Pharmaceutical Benefits Scheme. Lagevrio ®( molnupiravir) Pharmaceutical Benefits Scheme Factsheet – Updated 1 December 2024. https:// www. pbs. gov. au / publication / factsheets / covid-19-treatments / PBS-Factsheet-lagevrio-molnupiravir-updated- December-2024. pdf( accessed December 2024). 3. LAGEVRIO Product Information, October 2023. 4. Bernal AJ et al. N Engl J Med 2022; 509 – 520. 5. Van Heer C et al. Lancet Reg Health West Pac 2023; 41:100917. 6. Gentry CA et al. J Infect 2023; 86( 3): 248 – 255. 7. Lin DY et al. JAMA Netw Open 2023; 6( 9): e2335077. 8. Park HR et al Infect Chemother 2023; 55( 4): 490 – 499. 9. Abu Ahmad W et al. Clin Microbiol Infect 2024; 30( 10): 1305 – 1311. 10. Paxlovid( nirmatrelvir-ritonavir) Product Information. December 2024. 11. University of Liverpool. COVID-19 Drug Interaction Checker. Available at https:// covid19-druginteractions. org / checker( accessed March 2024).
Before prescribing, please review the full Product Information available at www. msdinfo. com. au / lagevriopi or by scanning the QR code.
Copyright © 2025 Merck & Co., Inc., Rahway, NJ, USA and its affi iates. All rights reserved. Merck Sharp & Dohme( Australia) Pty Limited. Level 1 – Building A, 26 Talavera Road, Macquarie Park NSW 2113. MSDA0156 / 01. AU-ANV-00634 v2.0. Issued January 2025.
Ciara Seccombe THE sperm of a prolific donor carried an undetected genetic cancer risk, which was only discovered when 10 of the 67 known children he fathered developed cancers.
Some of the man’ s sperm contained variants of the tumour protein 53( TP53) gene, which is responsible for DNA repair and regulating cell division in the body to prevent tumours.
People with a faulty TP53 gene have a 40 % chance of developing any cancer by age 18, which increases to 95 % by age 60.
After two of the children developed the cancers, which included leukaemia and non-Hodgkin’ s lymphoma, their families contacted the European Sperm Bank, which had supplied the sperm, and the genetic risk was discovered.
Sixty-seven of the children he had fathered were genetically tested: 23 had the abnormal TP53 gene, and 10 had already developed cancers. The children were born between 2008 and 2015.
The case was presented to the European Society of Human Genetics annual conference by Dr Edwige Kasper( PhD), a biologist at Rouen University Hospital in France.
“ Although the variant would have been practically undetectable in 2008 when the individual started to donate sperm, there are many things that could have been and still need to be improved,” Dr Kasper said.
She added that the sperm bank would not tell her how many children he had fathered but it was more than the 67 who had been tested. Different countries in Europe have set limits on the number of donations a single man can make within their borders, but those rules are not harmonised across jurisdictions, meaning a man could travel from country to country making dozens of donations.