January 23, 2023

HIV Medications: New Approval and News of Discontinuations

Every year, an estimated 385,000 needlestick and other sharps-related injuries occur among hospital-based healthcare personnel, which can potentially expose these workers to HIV, requiring Postexposure Prophylaxis (PEP) treatment with an antiretroviral regimen.

Antiretrovirals make up a small but costly part of workers’ comp drug spend, and keeping up to date with these HIV medications is beneficial to payers whose covered populations include healthcare workers.

Recently, ViiV Healthcare, a GlaxoSmithKline company, communicated to the FDA that several HIV medications they manufacture will be discontinued by the end of 2023. While many of these drugs have generics on the market, the decrease in production could potentially impact populations taking these medications. Of note, there are several medications on this list that are included in the Updated U.S. Public Health Service Guidelines for the Management of Occupational Exposures to HIV and Recommendations for Postexposure Prophylaxis.

Impacted medications include:

  • Epzicom® (abacavir sulfate, lamivudine) 600/300mg tablets will be discontinued on January 1, 2024
  • Lexiva® (fosamprenavir calcium) 700 mg tablets and the 50mg/mL oral solution (225mL) will no longer be available on January 1, 2024. Of significant note, there is no generic availability for the oral solution formulation of this medication
  • Selzentry® (maraviroc) 25mg and 75mg tablets are expected to cease production by January 1, 2024. However, the 150mg dose, 300 mg dose, and oral solution formulation of Selzentry will not cease production
  • Tivicay® (dolutegravir) 10mg and 25mg tablets will no longer be available as of January 1, 2024. There is currently no generic formulation of Tivicay currently available, though 50mg tablets and Tivicay PD 5mg will remain available
  • Trizivir® (abacavir sulfate, lamivudine, zidovudine) 300mg/150mg/300mg tablets will be discontinued by November 27, 2023
  • Ziagen® (abacavir sulfate): 300mg tablets will cease distribution on January 1, 2024. Ziagen Oral Solution will continue to be available

Lexiva, Selzentry, and Ziagen are all included in the guidelines in the section entitled “alternative antiretroviral agents for use as pep only with expert consultation.”

Also of note, the FDA recently approved Sunlenca® (lenacapavir) tablets for the treatment of HIV-1 infection, in combination with other antiretrovirals, among heavily treatment-experienced patients with multidrug resistance to HIV-1 infection, failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations.

While not as directly relevant to workers’ comp covered populations, this approval is meaningful to individuals with HIV where existing medication regimens are ineffective.

For ongoing coverage of the latest drug approvals and alerts impacting workers’ comp, visit Med Monitor online.

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