At IDWeek 2018, a major recurring theme throughout the conference was how novel treatment and prevention strategies for human immunodeficiency virus (HIV) can improve disease outcomes.
Speakers highlighted new antiretroviral therapy (ART) drugs and combinations, as well as methods to expand the use of Truvada (emtricitabine/tenofovir disoproxil fumarate [TDF]) as pre-exposure prophylaxis (PrEP) for high-risk individuals who currently have limited access.
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A promising but unproven ART combination is the use of dolutegravir (DTG) with boosted darunavir (bDRV), which was explored in a retrospective cohort study that ran from 2013-2017. In a group of highly treatment-experienced patients with a median of 19 prior years of ART exposure, DTG/bDRV dual therapy produced sustained viral suppression (HIV-RNA ≤200 cp/mL), even in those patients who were not baseline suppressed at the beginning of the study. Experts believe this combination holds great potential due to its high genetic barrier to resistance, reduced pill burden, and low cytotoxicity profile, particularly for patients with TDF toxicity or intolerance.
A speaker also presented week 96 results from the Phase III EMERALD trial of virologically-suppressed adults switching from boosted-protease inhibitors plus emtricitabine/TDF (F/TDF) to once-daily, single-tablet regimen (STR) darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF). This was an extension of previously published results which had shown the non-inferiority of the D/C/F/TAF STR at week 48 of this study. Of the 699 patients that continued to Week 98, only 3.1% had virologic rebound cumulative through the end of the study, and 91% had HIV-RNA levels below 50 cp/mL. The drug regimen was well tolerated, with no resistance mutations detected post-baseline. GlobalData believes STRs offer an important option for HIV patients who struggle with adherence to multi-tablet regimens. The D/C/F/TAF STR was approved by the FDA in July 2018 for treatment of HIV in treatment-naïve and virologically suppressed adults, and is marketed by Janssen as Symtuza.
On the HIV prevention front, focus is being placed on expanding access to PrEP for high-risk communities, including expanding the currently limited number of providers willing to prescribe PrEP. One solution is an alternative model utilising pharmacists with prescriptive authority, granted through pharmacist clinician licenses. The first pharmacy-run HIV clinics were established in New Mexico in 2015, encompassing PrEP education and implementation programmes. Out of the 126 patients who began PrEP through this clinic, including 42% Hispanic enrollees, patients had a median compliance rate of 99% and no HIV seroconversions were recorded through 2017. A similar programme in Nebraska leveraging six pharmacists from four sites successfully completed 139 patient visits during a six month period, with zero seroconversions.
Another critical barrier is the price of PrEP. From a period of 14 years between August 2004 and 2018, the wholesale cost of Truvada increased by 158%. These cost issues have exacerbated inequitable access, with only 167,000 individuals on PreP in the US as of 2018 out of the estimated one million at-risk people. Experts at IDWeek believe that in order to compel a change in the pricing structure for Truvada, physicians must take an active role in both understanding costs of the treatments they recommend and sustaining public discourse on pricing.
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