A randomized study to evaluate injection site reactions using three different enfuvirtide delivery mechanisms (the OPTIONS study)

Background: The antiretroviral enfuvirtide (ENF) is injected subcutaneously using a 27-gauge needle. Injection site reactions (ISRs) can affect long-term ENF tolerability. Alternative ENF delivery methods may ameliorate ISRs. Methods: We conducted a multicentre, open-label, randomized controlled trial in which patients receiving ENF were randomized to continue receiving ENF by a 27-gauge needle, a shorter 31-gauge needle or a gas-powered, needle-free injection device (NFID). The primary study endpoint was the proportion of participants with 0.2). There was no significant between-group difference for any ISR endpoint, except for changes in the composite ISR score (that is, no ongoing pain of >grade 1 or ISR for ongoing pain >grade 1 with induration ISR

Keywords:

• Virology
• Randomized controlled trial
• Enfuvirtide
• Enfuvirtida
• Adverse effect
• Randomization
• Population
• Surgery
• Internal medicine
• Fusion inhibitor
• Medicine
• Tolerability
• Patient satisfaction
• Viral load

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