A study in 18 healthy volunteers (Hoqueloux L et al, 2021) showed that Biktarvy® tablet dissolved in water caused a very modest increase and decrease in the bioavailability of bictegravir and tenofovir alafenamide, respectively. The crushed tablet in applesauce resulted in reduced bioavailability of tenofovir and emtricitabine compared to the whole tablet. Based on these data, Biktarvy® could be administered dissolved in water for patients with swallowing difficulties, provided that TDM of bictegravir and tenofovir (when available) is performed for prolonged administration.
There are five case reports of the administration of crushed Biktarvy® tablets. In three cases, the viral load of subjects who took crushed or dissolved Biktarvy® for a short period remained undetectable. In two cases, subjects were unable to achieve virologic suppression after receiving crushed Biktarvy®.
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The first case, a 78-year-old African-American man newly diagnosed with pancreatic cancer, underwent PEG tube placement during his hospital stay and chemotherapy was initiated as an outpatient upon discharge. The patient retained the PEG tube due to persistent dysphagia and was advised to crush Biktarvy® in order to continue the same ART regimen as he wished. The patient’s viral load remained undetectable after 7 months of crushed Biktarvy® diluted in 30-60 mL of water administered via the PEG tube separately from self-administered tube feedings throughout chemotherapy to avoid interactions with polyvalent cations (Roa and Bazzi, 2022).
The second case, a 64-year-old man with significant dysphagia secondary to esophageal cancer. The viral load remained undetectable for 10 months with the administration of crushed Biktarvy® in 30 to 60 ml of water via the PEG tube followed immediately after the administration of 240 ml of an enteral formula (Jevity 1.2) (Fulco PP et al, 2020).
The third case, a 52-year-old woman who dissolved Biktarvy® tablet in a tablespoon of orange juice (without any manipulation) and then swallowed after 10 minutes. The patient did not consult her pharmacist or her treating physician before starting this method of administration. Treatment continued for 12 months and the patient maintained a viral load < 20 c/mL and her CD4 count increased (baseline: 282 cells/μL; after 12 months: 370 cells/μL). The authors visually observed that the film coating dissolved completely after 4 minutes and that the tablet disintegrated in orange juice (pH 4) after 14 minutes without shaking (Ferrandez JS et al, 2020).
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The fourth case, a 43-year-old man newly diagnosed with HIV and hospitalized with a viral load of 769,704 c/mL and a CD4 count of 36 cells/μL. On hospital day 8, he was started on daily oral Biktarvy®. On day 28, after receiving 14 of 20 scheduled doses, his viral load was 5,887 c/mL. On day 38, he was started on crushed Biktarvy® diluted in 30 mL of water administered through a PEG tube with continuous tube feeding. By day 65, the patient had received 37 consecutive doses of Biktarvy® and his HIV RNA level was 8,047 c/mL. On day 67, his ARV treatment was changed to DTG twice daily + DRV/r + FTC/TDF. A resistance panel showed E157Q and V118I mutations. He was discharged on day 161 and oral Biktarvy® was resumed after the PEG tube was removed 2 months later, at which time his viral load was 429 c/mL. The patient achieved virologic suppression and remained suppressed at 1-year follow-up (Rowe SM et al, 2022).
The last case, a 39-year-old woman with dysphagia due to progressive multifocal leukoencephalopathy. An adequate virologic response of 4 weeks (decreased from 1,023,292 to 1,084 copies / mL) and then with Biktarvy® crushed and administered as a solution via the nasogastric tube for 6 weeks. However, 12 weeks after starting Biktarvy®, the patient’s viral load increased and several mutations appeared (M184V, L74I and R263K). It is not known whether the failure of Biktarvy® is due to previous exposure to antiretrovirals (with failure and resistance) or administration of the crushed Biktarvy® tablet (Lozano AB et al, 2020).
For the company, the data is currently insufficient and they recommend against cutting or crushing the tablet and swallowing it whole.
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