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 < grade 2 ISR induration at week 12.


RESULTS
Sixty patients received treatment and were included in the intention-to-treat population. The cohort was predominantly male (95%) with a mean age of 49.1 (SD +/- 7.7) years who had injected ENF for a mean of 821 (SD +/- 561) days. Response rates for ISR induration at week 12 were 38%, 25% and 42% for the 27-gauge, 31-gauge and NFID groups, respectively (all pairwise treatment comparison P-values > 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 > or = grade 1 with induration ISR < grade 3 and for nodules < grade 2), which favoured the 27-gauge needle and NFID groups over the 31-gauge group (P = 0.012 and 0.047, respectively). Plasma HIV RNA load was unaffected. There were seven adverse events related to the delivery system: five attributed to the NFID. At week 12, 85% of participants elected to use the NFID.


CONCLUSIONS
Needle-free ENF injection offers a reasonable, reliable alternative to needle-based injecting in this population, at least in the short term.
National Centre in HIV Epidemiology and Clinical Research, University of New South Wales, Sydney, NSW 2010, Australia. mboyd@nchecr.unsw.edu.au
Mark A
MA
Boyd
Matt
M
Truman
Gillian
G
Hales
Jonathan
J
Anderson
Dominic E
DE
Dwyer
Andrew
A
Carr
D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001315:Australia; D000077560:Enfuvirtide; D004867:Equipment Design; D005260:Female; D006678:HIV / Q000187:drug effects / Q000235:genetics; D015700:HIV Envelope Protein gp41 / Q000008:administration & dosage* / Q000009:adverse effects; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D007277:Injections, Jet / Q000009:adverse effects; D007279:Injections, Subcutaneous / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009339:Needles; D010146:Pain / Q000209:etiology / Q000517:prevention & control*; D010147:Pain Measurement; D017060:Patient Satisfaction; D010446:Peptide Fragments / Q000008:administration & dosage* / Q000009:adverse effects; D012367:RNA, Viral / Q000097:blood; D012871:Skin Diseases / Q000209:etiology / Q000517:prevention & control*; D016896:Treatment Outcome; D019562:Viral Load
D000998:Antiviral Agents; D015700:HIV Envelope Protein gp41; D010446:Peptide Fragments; D012367:RNA, Viral; D000077560:Enfuvirtide