Symptoms, Side Effects and Adherence in the iPrEx Open-Label Extension

Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America
David V GliddenRobert M Grant

Abstract

Blinded clinical trials have reported a modest and transient "start-up syndrome" with initiation of tenofovir-based pre-exposure prophylaxis (PrEP). We evaluate this phenomenon and its effect on adherence in an open-label PrEP study. In the iPrEx open-label extension (OLE) study, an 18-month open-label, multi-site PrEP cohort taking daily oral co-formulated tenofovir/emtricitabine, we examined the prevalence and duration of PrEP-associated symptoms and their effect on adherence, assessed by drug levels in dried blood spots tested monthly for the first 3 months. Symptom reports peaked within the first month, with 39% reporting potentially PrEP-related symptoms compared to 22% at baseline. Symptoms largely resolved to pre-PrEP levels by 3 months.Symptoms varied substantially in frequency by study site (range in 1-month symptoms: 11% to 70%). Nongastrointestinal (GI) symptoms were not associated with adherence (odds ratio [OR] = 1.2, 95% confidence interval [CI], .4-3.7); however, GI-associated symptoms in the first 4 weeks were inversely associated with adherence at 4 weeks (OR = 0.47, 95% CI, .23-.96). Reports of GI symptoms were associated with 7% (95% CI, 4%-11%) of suboptimal adherence in this cohort. PrEP-associated symptoms...Continue Reading

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Citations

Feb 1, 2017·Journal of Women's Health·Gifty-Maria J Ntim, Lisa N Kransdorf
Mar 21, 2018·AIDS and Behavior·Alex DubovLiana Fraenkel
Apr 19, 2017·Journal of the International AIDS Society·Brenda HoaglandUNKNOWN PrEP Brasil Study TeamClinical Trial Number 01989611
Mar 27, 2018·Journal of the International AIDS Society·J Carlo HojillaAdam W Carrico
Mar 14, 2020·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Matthew A SpinelliUNKNOWN Partners PrEP Study Team
Oct 7, 2018·British Journal of Hospital Medicine·Nina Vora, John Saunders
Mar 29, 2018·AIDS and Behavior·Christine Tagliaferri RaelAlex Carballo-Diéguez
May 20, 2020·Current HIV/AIDS Reports·Matthew A SpinelliMonica Gandhi
Apr 29, 2021·Revista Panamericana De Salud Pública = Pan American Journal of Public Health·Anton Best, Nastassia Rambarran
May 15, 2021·Primary Care·Asa Radix, Rona Vail

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