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2022

Kemal Atlay PATIENTS with contraindications to

daily oral HIV pre-exposure prophylaxis

could soon access a PBS-subsidised

long-acting injectable .

Following its September meeting

, the PBAC has recommended a streamlined authority listing for long-acting cabotegravir ( Apretude ) as an HIV pre-exposure prophylaxis ( PrEP ) alternative .

The antiviral , which was approved by the TGA in 2022 , is an integrase strand transfer inhibitor

that disrupts the HIV replication cycle .

Patients must have a documented negative HIV test before starting treatment and weigh at least 35kg , according to the product information .

It is contraindicated in those with positive or unknown HIV status , known hypersensitivity to cabotegravir or any excipients and in those who are using rifampicin , rifapentine , phenytoin , phenobarbital , carbamazepine or oxcarbazepine .

The PBAC deferred a decision

earlier this year “ to allow further deliberation on the population who should be eligible … and the associated PBS restrictions ”.

“ The PBAC noted the submission requested a listing … only for people who are contraindicated or intolerant to or were repeatedly non-adherent to oral [ tenofovir disoproxil with emtricitabine ] to the extent efficacy and safety were compromised ,” it said at the time . Following the meeting in July , sponsor ViiV Healthcare revised its price offer and proposed criteria .

The revised proposals offered “ simpler ” eligibility assessment with “ an equitable and acceptably cost-effective listing ”, according to the PBAC .

Clinical trial data have suggested the injectable PrEP regimen is as effective or superior to daily oral PrEP . For new patients , two initiation doses ( 3mL / 600mg IM ) are administered a month apart .

Subsequent doses are scheduled once every two months , within seven days of the scheduled dosing date .

The injectable is an alternative to oral PrEP .

Rachel Fieldhouse PATIENTS using GLP-1 receptor agonists for weight loss are nine times more likely to develop pancreatitis than those taking bupropion – naltrexone , researchers say . Use of liraglutide and semaglutide were also associated with a near fourfold increased risk of bowel obstruction and gastroparesis compared with the older fixed-dose combination treatment .

The University of British Columbia – led team analysed US patient prescription and diagnosis data from 2006 to 2020 to assess the risk of gastrointestinal disorders with the weight loss drugs .

The cohort included 4144 liraglutide users , 613 semaglutide users and 654 taking bupropion – naltrexone .

Overall , reports of pancreatitis , bowel obstruction and gastroparesis were significantly higher in patients taking either GLP-1 receptor agonist versus bupropion – naltrexone regardless of history of obesity or hyperlipidaemia .

For instance , the incidence of pancreatitis per 1000 person-years was 7.9 for liraglutide , 4.7 for semaglutide and 1.0 for bupropion – naltrexone .

The Canadian authors also detected a link between GLP-1 receptor agonists and biliary disease , but this was not statistically significant .

“ Given the wide use of these drugs , these adverse events — although rare — must be considered by patients who are contemplating using the drugs for weight loss because the risk – benefit calculus for this group might differ from that of those who use them for diabetes ,” they concluded .

The analysis excluded patients with diabetes and those without obesity to account for the marketing of semaglutide for weight loss after the study period had ended . JAMA 2023 ; 5 Oct .

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