Efficacy of flurbiprofen 8.75 mg spray in patients with sore throat due to an upper respiratory tract infection: A randomised controlled trial

<p><b>Background:</b> Viral infections cause most cases of pharyngitis (sore throat); consequently, antibiotics are generally not warranted. However, a treatment targeting pain and inflammation, e.g. a topical non-steroidal anti-inflammatory spray, may be helpful for patients.</p> <p><b>Objective:</b> To evaluate the efficacy and safety of flurbiprofen 8.75 mg spray.</p> <p><b>Methods:</b> This randomised, double-blind, parallel group study was conducted at six community-based clinical research centres in Australia and two in New Zealand. Adults with sore throat due to upper respiratory tract infection (onset ≤ four days) took one dose of flurbiprofen (<i>n</i> = 249) or placebo spray (<i>n</i> = 256); after six hours, they could re-dose every three–six hours as required, for three days (max. five doses/day). The primary endpoint was the area under the change from baseline curve in throat soreness from zero–two hours (AUC_0–2h). The change from baseline in other sore throat symptoms also assessed efficacy.</p> <p><b>Results:</b> The mean AUC_0–2h for throat soreness was significantly greater with flurbiprofen spray (−1.82; 95% CI: −1.98 to 1.65) compared with placebo (−1.13; 95% CI: −1.27 to 0.99) (<i>P</i> < 0.0001). Significantly greater reductions from baseline were observed with flurbiprofen spray compared with placebo from the first time-points assessed (five minutes for throat soreness/difficulty swallowing, 20 minutes for sore throat pain intensity and 30 minutes for swollen throat) for up to six hours (<i>P</i> < 0.05 for all). There was no significant difference in adverse events between treatment groups during the three-day study.</p> <p><b>Conclusion:</b> Flurbiprofen spray provides rapid and long-lasting relief from sore throat symptoms, and is well-tolerated over three days.</p

Number of comorbidities by HIV status and age group.

<p>Number of comorbidities by HIV status and age group.</p

Unadjusted and adjusted odds for selected self-reported comorbidities (HIV positive compared to HIV negative men).

<p>Unadjusted and adjusted odds for selected self-reported comorbidities (HIV positive compared to HIV negative men).</p

Participant self-report lifestyle behaviours by HIV status^*.

<p>Participant self-report lifestyle behaviours by HIV status^{<a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0184583#t002fn001" target="_blank">*</a>}.</p

Selected self-reported comorbidities by HIV status.

<p>*denotes (unadjusted) P-value < 0.05 **hypertension—self reported “high blood pressure”.</p

Switching to the single-tablet regimen of elvitegravir, cobicistat, emtricitabine, and tenofovir DF from non-nucleoside reverse transcriptase inhibitor plus coformulated emtricitabine and tenofovir DF regimens: Week 96 results of STRATEGY-NNRTI

<p><b>Background:</b> HIV-1-infected, virologically suppressed adults wanting to simplify or change their non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimens may benefit from switching to the single-tablet regimen of elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate (E/C/F/TDF).</p> <p><b>Objective:</b> We examined differences in the proportion of participants with HIV-1 RNA < 50 copies/mL (Snapshot analysis), change in CD4 cell count, safety, and patient-reported outcomes in participants switching to E/C/F/TDF from an NNRTI + FTC/TDF (TVD) regimen.</p> <p><b>Methods:</b> STRATEGY-NNRTI was a 96-week, phase 3b, randomized, open-label, study examining the efficacy, safety, and tolerability of switching to E/C/F/TDF in virologically suppressed individuals (HIV-1 RNA < 50 copies/mL) on an NNRTI + TVD regimen. Participants were randomized to switch or remain on their NNRTI-based regimen (no-switch).</p> <p><b>Results:</b> At Week 96, 87% (251/290) of switch and 80% (115/143) of no-switch participants maintained HIV-1 RNA < 50 copies/mL (difference 6.1%; 95% CI −1.3 to 14.2%; <i>p</i> = 0.12) according to the FDA-defined snapshot algorithm. Both groups had similar proportions of subjects with virologic failure (2.8% switch, 1.4% no-switch). Discontinuations resulting from adverse events were infrequent (3% [9/291] switch, 2% [3/143] no-switch). Three switch participants (1%) discontinued due to renal adverse events (2 of the 3 before Week 48). Switch participants reported significant improvements in neuropsychiatric symptoms by as early as Week 4, and which were maintained through Week 96.</p> <p><b>Conclusions:</b> E/C/F/TDF is safe and effective and reduces NNRTI-associated neuropsychiatric symptoms for virologically suppressed HIV-positive adults switching from an NNRTI plus FTC/TDF-based regimen.</p

Change in Plasma Concentrations of Lipids and Lipoproteins

<p>Adjusted for sex, region, pVL decrease, and CD4+-cell increase.</p