+ Resolve Article
+ Follow Us
Follow on FacebookFollow on Facebook
Follow on TwitterFollow on Twitter

+ Translate
+ Subscribe to Site Feed
GeoScience Most Shared ContentMost Shared Content

Patient-Reported Symptoms Over 48 Weeks in a Randomized, Open-Label, Phase IIIb Non-Inferiority Trial of Adults with HIV Switching to Co-Formulated Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir DF versus Continuation of Non-Nucleoside Reverse Transcriptase Inhibitor with Emtricitabine and Tenofovir DF

, : Patient-Reported Symptoms Over 48 Weeks in a Randomized, Open-Label, Phase IIIb Non-Inferiority Trial of Adults with HIV Switching to Co-Formulated Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir DF versus Continuation of Non-Nucleoside Reverse Transcriptase Inhibitor with Emtricitabine and Tenofovir DF. Patient 8(4): 359-371

Co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF; Stribild(®)) is a guideline-recommended regimen for HIV treatment-naïve patients and a switch option for virologically suppressed patients. The purpose of this analysis was to understand how HIV patients' symptoms change after switching to Stribild(®) versus continuing a regimen consisting of a non-nucleoside reverse transcriptase inhibitor (NNRTI) with emtricitabine and tenofovir disoproxil fumarate. A secondary analysis was conducted of the STRATEGY-NNRTI study (GS-US-236-0121), a randomized, open-label, phase IIIb trial of HIV-infected adults who were taking an NNRTI plus FTC/TDF and were randomly assigned (2:1) either to Stribild(®) ('switch') or to continue on their existing regimen ('no-switch'). Logistic regressions and longitudinal modeling were conducted to evaluate the relationship of treatment with bothersome symptoms. These models adjusted for age, sex, race, number of bothersome symptoms at baseline, Veterans Aging Cohort Study Risk (VACS) Index score, years since HIV diagnosis, and first antiretroviral therapy use, NNRTI type, serious mental illness, and baseline depression and health-related quality of life (HRQL) scores. At baseline, the prevalence of nightmares, vivid dreams, weird/intense dreams, muscle aches/joint pain, and fevers/chills/sweats was greater in the switch group. The prevalence of nightmare, vivid dreams, weird/intense dreams, dizzy/lightheadedness, fatigue/loss of energy, and pain/numbness/tingling in hands/feet deceased in the switch group at week 4, and these benefits were maintained over time. Nervous/anxious, drowsiness, trouble remembering, off balance, and body changes decreased in the switch group at week 4 but were not maintained over time. Difficulty sleeping, diarrhea/loose bowels, and bloating did not differ in prevalence at week 4 or 48, but longitudinal models suggested differences between groups over time. HRQL did not differ between groups and was unchanged over time. In this study sample, a switch to co-formulated EVG/COBI/FTC/TDF was associated with significant persistent improvements in six patient-reported HIV symptoms.


PMID: 26045359

DOI: 10.1007/s40271-015-0129-9

Other references

Anonymous, 1969: Editorial. Dental specialties. Dental Practitioner and Dental Record 20(1): 1-1

Cao, L.S.; Qi, D.X.; Peng, R.W.; Wang, M.; Schmelcher, P., 2014: Phononic frequency combs through nonlinear resonances. We explore an analogue of optical frequency combs in driven nonlinear phononic systems, and present a mechanism for generating phononic frequency combs through nonlinear resonances. In the underlying process, a set of phonon modes is simultaneousl...

Chou, H.C.; Ozawa, S.; Yamazoe, Y.; Kato, R.; Kadlubar, F.F., 1994: The expression and substrate specificity of the cDNAs for human and rat liver sulfotransferases. Proceedings of the American Association for Cancer Research Annual Meeting 35(0): 138

Matsushita, S.; Kawamura, M.; Takahashi, M.; Yokoyama, K.; Konishi, N.; Yanagawa, Y.; Kai, A.; Yamada, S.; Morozumi, S.; Kudoh, Y., 2001: Serovar-distribution and drug-resistance of Salmonella strains isolated from domestic and imported cases during 1995-1999 in Tokyo. A total of 2,277 non-typhoidal Salmonella strains consisting of 1,807 domestic strains and 470 imported strains isolated from sporadic cases during 1995-1999 in Tokyo, were examined regarding their serovar-distibution and their drug-resistance. Th...

Marchini, S.; Cavalieri, D.; Fruscio, R.; Calura, E.; Garavaglia, D.; Fuso Nerini, I.; Mangioni, C.; Cattoretti, G.; Clivio, L.; Beltrame, L.; Katsaros, D.; Scarampi, L.; Menato, G.; Perego, P.; Chiorino, G.; Buda, A.; Romualdi, C.; D'Incalci, M., 2011: Association between miR-200c and the survival of patients with stage I epithelial ovarian cancer: a retrospective study of two independent tumour tissue collections. International Federation of Gynecology and Obstetrics stage I epithelial ovarian cancer (EOC) has a significantly better prognosis than stage III/IV EOC, with about 80% of patients surviving at 5 years (compared with about 20% of those with stage...

Tkeshelashvili, L.K., 1957: FRate of renewal of phosphorylcholine and phosphorylethanolamine in the animal organism. The rate of renewal of phosphorylcholine (I) and phosphorylethanolamine (II) was studied in the brain, liver, spleen, kidneys, heart and skeletal muscles of rats and rabbits, and in various sections of the brain (grey and white matter of the cereb...

Almeida, W.I.; Martins, O.B.; Carvalho-Alves, P.C., 2006: Self-association of isolated large cytoplasmic domain of plasma membrane H+ -ATPase from Saccharomyces cerevisiae: role of the phosphorylation domain in a general dimeric model for P-ATPases. Large cytoplasmic domain (LCD) plasma membrane H+ -ATPase from S. cerevisiae was expressed as two fusion polypeptides in E. coli: a DNA sequence coding for Leu353-Ileu674 (LCDh), comprising both nucleotide (N) and phosphorylation (P) domains, and...

Tsuchiya, H.; Takazawa, H.; Yamaguchi, A.; Ogawa, W., 1967: 83 cases of deformity caused by thalidomide and its problems. Seikeigeka. Orthopedic Surgery 18(4): 301-303

Ligon, J.David, 1967: Relationships of the cathartid vultures. Although it has long been known that there are many basic differences between the Cathartidae and Accipltridae, and between the Ardeidae and Ciconii-dae, they have been retained in the same orders, Falconiformes and Ciconiiformes, respectively. Th...

Harlow, W.M., 1945: Some comments on the new Check List and other things nomenclatural. A proposed revision of the U.S. Forest Service Check List of the native and naturalized trees of the United States is the occasion of this article on problems of plant nomenclature. The author believes that strict adherence to the international ru...