Author | Glidden, David V. | |
Author | Amico, K. Rivet | |
Author | Liu, Albert Y. | |
Author | Hosek, Sybil G. | |
Author | Anderson, Peter L. | |
Author | Buchbinder, Susan P. | |
Author | McMahan, Vanessa | |
Author | Mayer, Kenneth H. | |
Author | David, Burns | |
Author | Schechter, Mauro | |
Author | Grinsztejn, Beatriz | |
Author | Guanira, Juan | |
Author | Grant, Robert M. | |
Access date | 2018-10-10T16:34:08Z | |
Available date | 2018-10-10T16:34:08Z | |
Document date | 2016 | |
Citation | GLIDDEN, David V. et al. Symptoms, Side Effects and Adherence in the iPrEx Open-Label Extension. Clinical Infectious Diseases, v. 62, n. 9, p. 1172–1177, May. 2016. | pt_BR |
ISSN | 1058-4838 | pt_BR |
URI | https://www.arca.fiocruz.br/handle/icict/29495 | |
Language | eng | pt_BR |
Publisher | The University of Chicago Press | |
Rights | open access | pt_BR |
Subject in Portuguese | HIV prevention | pt_BR |
Subject in Portuguese | Pre-exposure prophylaxis | pt_BR |
Subject in Portuguese | Tenofovir/emtricitabine | pt_BR |
Subject in Portuguese | PrEP | pt_BR |
Title | Symptoms, Side Effects and Adherence in the iPrEx Open-Label Extension | pt_BR |
Type | Article | pt_BR |
DOI | 10.1093/cid/ciw022 | |
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. | pt_BR |
Affilliation | University of California. San Francisco, USA. | pt_BR |
Affilliation | University of Michigan. Ann Arbor, USA. | pt_BR |
Affilliation | Bridge HIV. San Francisco Department of Public Health. California, USA. | pt_BR |
Affilliation | John Stroger Hospital of Cook County. Chicago, Illinois, USA. | pt_BR |
Affilliation | University of Colorado. Denver, Aurora, USA. | pt_BR |
Affilliation | Bridge HIV. San Francisco Department of Public Health. California, USA. | pt_BR |
Affilliation | University of Washington. Seattle,USA. | pt_BR |
Affilliation | Fenway Health and Beth Israel Deaconess Medical Center. Boston, Massachusetts, USA. | pt_BR |
Affilliation | National Institute of Allergy and Infectious Diseases. Rockville, Maryland, USA. | pt_BR |
Affilliation | Universidade Federal do Rio de Janeiro. Hospital Escola São Francisco de Assis. Projeto Praça Onze. Rio de Janeiro, RJ, Brasil. | pt_BR |
Affilliation | Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil. | pt_BR |
Affilliation | Investigaciones Médicas en Salud. Lima, Peru. | pt_BR |
Affilliation | Gladstone Institute of Virology and San Francisco AIDS Foundation. California, USA. | pt_BR |