Severe rhabdomyolysis and acute asymptomatic pancreatitis following the concomitant use of Biktarvy in the setting of hyperosmolar diabetic crisis

Abstract

<jats:p>Biktarvy (bictegravir/emtricitabine/tenofovir alafemanide), which has been recently approved for the treatment of HIV, is a single-pill regimen that associates bictegravir and a novel integrase strand transfer inhibitor (INSTI) with a combination of two nucleoside reverse transcriptase inhibitors (NRTI) of emtricitabine and tenofovir alafemanide. Among treatment complications, rhabdomyolysis has been reported in association with some NRTI and INSTI but never with bictegravir. Acute pancreatitis has also been reported recently with another INSTI, dolutegravir. We report here a 62-year-old man with diabetes and HIV infection, and receiving Biktarvy for 1 month. He presented to the emergency department for muscular pain and fatigue. He was on treatment with Descovy (tenofovir alafenamide/emtricitabine) and Viramune (nevirapine) for 2 years but he recently asked for a regimen simplification. Severe rhabdomyolysis and acute pancreatitis were diagnosed. Although the aetiology of these events could be multifactorial, it cannot be ruled out that this episode could be linked to a potential side effect of bictegravir.</jats:p>

Assessment of Gastrointestinal Adverse Effects during the First Six Months of “Biktarvy” Antiretroviral Therapy: Age-Related Patterns and Their Relation with Changes of 5 kg Weight Loss/Gain in the Initial Treatment Period

“…In the medical literature, there have been reports of other adverse events associated with this antiretroviral medication. Notably, cases of severe rhabdomyolysis and acute asymptomatic pancreatitis have been documented, particularly when BIKTARVY ® was used concomitantly in the context of a hyperosmolar diabetic crisis [30]. These findings underscore the importance of closely monitoring patients and being aware of potential complications when administering this medication.…”

Pharmacokinetic interactions of modern antiretroviral therapy

“…Bictegravir, the newer second-generation INSTI, is coformulated with emtricitabine and TAF as a single tablet regimen (Biktarvy) for treatment of HIV in patients without past or present INSTI resistance [39,40]. It is a substrate of CYP3A4 and UGT1A1 [41], and is likely to be a victim of drug interactions by potent inducers or inhibitors of these enzymes with resultant decrease or increase of drug exposure, respectively. In a healthy volunteer study, twice daily administration of bictegravir/ emtrictabine/TAF did not mitigate the induction effect of rifampicin on bictegravir [42].…”