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Clin Infect Dis. 2016 May 1;62(9):1172-7. doi: 10.1093/cid/ciw022. Epub 2016 Jan 20.

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

Author information

1
University of California, San Francisco.
2
University of Michigan, Ann Arbor.
3
Bridge HIV, San Francisco Department of Public Health, California.
4
John Stroger Hospital of Cook County, Chicago, Illinois.
5
University of Colorado, Denver, Aurora.
6
University of Washington, Seattle.
7
Fenway Health and Beth Israel Deaconess Medical Center, Boston, Massachusetts.
8
National Institute of Allergy and Infectious Diseases, Rockville, Maryland.
9
Projeto Praça Onze, Hospital Escola São Francisco de Assis and Universidade Federal do Rio de Janeiro, and.
10
Evandro Chagas National Institute of Infectious Diseases-Fiocruz, Rio de Janeiro, Brazil.
11
Investigaciones Médicas en Salud, Lima, Peru.
12
Gladstone Institute of Virology and San Francisco AIDS Foundation, California.

Abstract

BACKGROUND:

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.

METHODS:

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.

RESULTS:

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.

CONCLUSIONS:

PrEP-associated symptoms in the open-label setting occur in a minority of users and largely resolve within 3 months. GI symptoms are associated with a modest reduction in PrEP adherence, but good adherence is possible even in the presence of frequent symptom reports.

CLINICAL TRIALS REGISTRATION:

Clinicaltrials.govNCT00458393.

KEYWORDS:

HIV prevention; PrEP; pre-exposure prophylaxis; tenofovir/emtricitabine

PMID:
26797207
PMCID:
PMC4826449
DOI:
10.1093/cid/ciw022
[Indexed for MEDLINE]
Free PMC Article

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