Dataset Information

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

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.

SUBMITTER: Glidden DV

PROVIDER: S-EPMC4826449 | biostudies-literature | 2016 May

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Glidden David V DV Amico K Rivet KR Liu Albert Y AY Hosek Sybil G SG Anderson Peter L PL Buchbinder Susan P SP McMahan Vanessa V Mayer Kenneth H KH David Burns B Schechter Mauro M Grinsztejn Beatriz B Guanira Juan J Grant Robert M RM

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America 20160120 9

<h4>Background</h4>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.<h4>Methods</h4>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 eff ...[more]

PMID: 26797207

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Dataset Information

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

Background

Methods

Results

Conclusions

Clinical trials registration

Publications

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

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