quad-pill and HIV-Infections

quad-pill has been researched along with HIV-Infections* in 35 studies

Reviews

7 review(s) available for quad-pill and HIV-Infections

ArticleYear
Genvoya-Associated and Simvastatin-Associated Noninflammatory and Nonautoimmune Myopathy: A Case Report and Literature Review.
    Journal of clinical neuromuscular disease, 2022, Dec-01, Volume: 24, Issue:2

    Patients with HIV have a higher incidence of rhabdomyolysis compared with the HIV negative population because of medication-related myotoxicity and drug-drug interactions. Statins and antiretroviral therapy have been previously reported to cause myopathy in patients with HIV when used alone or in combination. In this study, we describe a case of biopsy-proven noninflammatory and nonautoimmune myopathy associated with the use of simvastatin and Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fumarate) and review 3 previously reported similar cases. Our patient presented with acute proximal limb weakness and significantly elevated serum creatine kinase. Muscle biopsy revealed scattered degenerating and regenerating muscle fibers without evidence for an inflammatory process. She did not respond to empiric treatment with high-dose intravenous steroids and intravenous immunoglobulin. Her creatine kinase only began to downtrend after discontinuation of both simvastatin and Genvoya, and she returned to baseline function at 2-month follow-up. Our case highlights the importance of recognizing drug-drug interactions between HIV and statin medications in causing significant noninflammatory myopathy. In these patients, both categories of medications need to be discontinued for recovery.

    Topics: Creatine Kinase; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Female; HIV Infections; Humans; Muscular Diseases; Simvastatin

2022
A Review of the Efficacy and Safety of Genvoya® (Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide) in the Management of HIV-1 Infection.
    Journal of pharmacy practice, 2018, Volume: 31, Issue:2

    This review evaluates the efficacy and safety of Genvoya® (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide [EVG/c/TAF/FTC]), a single-tablet regimen used for the management of HIV-1 infection. Phase II and III randomized clinical trials evaluate the efficacy and safety of EVG/c/TAF/FTC and tenofovir disoproxil fumerate (TDF)-containing arms; renal impairment, bone mineral density, metabolic effects, and other adverse events are topics explored within this review.. A MEDLINE with full text and PubMed literature search was conducted for the past 5 years, up to April 2016.. Virologic suppression was similar between the EVG/c/TAF/FTC and TDF-containing groups (<50 copies/mL) at week 48. The bone mineral density in the hip and spine showed a significant reduction in the TDF-containing groups. The glomerular filtration rate increased in patients in the EVG/c/TAF/FTC arm and there were significant differences in total proteinuria, albuminuria, and tubular proteinuria in patients switching to EVG/c/TAF/FTC. The most common adverse events were diarrhea, nausea, and headache.. The coformulated Genvoya regimen is well tolerated and effective in treatment-naive and virologically suppressed patients. Data seem to suggest it may also be effective and safe in patients with mild to moderate renal impairment. The lower-dosed single-tablet regimen has significantly reduced bone and renal side effects.

    Topics: Anti-HIV Agents; Clinical Trials, Phase III as Topic; Cobicistat; Diarrhea; Disease Management; Drug Combinations; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Emtricitabine; Headache; HIV Infections; HIV-1; Humans; Nausea; Quinolones; Randomized Controlled Trials as Topic; Tenofovir; Treatment Outcome

2018
The pharmacokinetics, pharmacodynamics and clinical efficacy of elvitegravir + cobicistat + emtricitabine + tenofovir combination therapy for the treatment of HIV.
    Expert opinion on drug metabolism & toxicology, 2015, Volume: 11, Issue:3

    Co-formulated elvitegravir, cobicistat, emtricitabine and tenofovir (EVG/COBI/FTC/TDF or Stribild™) is the latest antiretroviral tablet approved in the EU. This review aims to provide an overview of its role in the management of HIV-1 infection.. This review covers material searched and obtained through Medline and Pubmed up to July 2014.. Antiretroviral treatment prevents the progressive destruction of the immune system by the HIV, significantly reducing morbidity and mortality. The efficacy and tolerability of EVG/COBI/FTC/TDF compared to current standard of care as a single-tablet treatment choice has been shown in study 102 and study 103. Its use is restricted to patients without significant pre-existing renal impairment and may be limited by concomitant medications but undoubtedly increases treatment choice for HIV-1-infected adults.

    Topics: Adenine; Adult; Anti-HIV Agents; Carbamates; Deoxycytidine; Drug Approval; Drug Combinations; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; European Union; HIV Infections; HIV-1; Humans; Organophosphonates; Quinolones; Tablets; Thiazoles

2015
Stribild: a review of component characteristics and combination drug efficacy.
    European review for medical and pharmacological sciences, 2015, Volume: 19, Issue:5

    Numerous methods have been devised to combat human immunodeficiency virus (HIV) replication and disease progression. Composed of an integrase strand transfer inhibitor, a pharmacoenhancer, and two reverse transcriptase inhibitors, Stribild is a relatively new combination HIV drug formulated for once-a-day dosing.. Relevant information, original research articles and reviews, were gathered primarily through the use of the PubMed database. The search was conducted without date restrictions in order to collect both historical and recent information concerning HIV, individual drugs, and combinations for a thorough overview.. Stribild, when taken with food, provides therapeutic drug concentrations as seen through comparison with the respective individual or boosted individual drugs. Stribild non-inferiority has been shown when compared to other HIV drug combinations, ritonavir-boosted atazanavir or efavirenz each with a tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) backbone. The co-formulation also retained high viral suppression in patients switching from other regimens, such as efavirenz/TDF/FTC, raltegravir/TDF/FTC, or various ritonavir-boosted protease inhibitors with TDF/FTC. The elvitegravir and cobicistat combination was unaffected by moderate hepatic impairment; however, hepatic and renal function along with changes in bone mineral density should be monitored closely. Stribild presented with relatively few side effect occurrences, but drug interactions may pose a larger problem for continuous therapy.. Stribild provides viral suppression, comparable to other combination HIV drugs through review of non-inferiority and regimen simplification studies, with minimal adverse effects. Although the breadth of Stribild effectiveness has begun to unfold, studies are lacking in older patients as well as adolescents.

    Topics: Adenine; Anti-HIV Agents; Carbamates; Deoxycytidine; Drug Combinations; Drug Synergism; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; HIV Infections; Humans; Organophosphonates; Quinolones; Thiazoles

2015
Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate single-tablet regimen (Stribild®): a review of its use in the management of HIV-1 infection in adults.
    Drugs, 2014, Volume: 74, Issue:1

    A new single-tablet, fixed-dose formulation consisting of elvitegravir, an HIV-1 integrase strand transfer inhibitor (INSTI); cobicistat, a pharmacokinetic enhancer; emtricitabine, a nucleoside reverse transcriptase inhibitor; and tenofovir disoproxil fumarate (tenofovir DF), a nucleotide reverse transcriptase inhibitor (elvitegravir/cobicistat/emtricitabine/tenofovir DF 150 mg/150 mg/200 mg/300 mg; Stribild®) is available in some countries for the once-daily treatment of HIV-1 infection in antiretroviral therapy-naïve adults. Elvitegravir/cobicistat/emtricitabine/tenofovir DF is the first INSTI-based single-tablet regimen available for the complete initial treatment of adults with HIV-1 infection. In two large, randomized, double-blind, phase III trials, once-daily treatment with elvitegravir/cobicistat/emtricitabine/tenofovir DF was effective in reducing plasma HIV-1 RNA levels to <50 copies/mL at the week 48 assessment and showed virological efficacy noninferior to that of the efavirenz/emtricitabine/tenofovir DF single-tablet regimen or a once-daily regimen of atazanavir plus ritonavir (ritonavir-boosted atazanavir) plus the fixed-dose combination of emtricitabine/tenofovir DF. Elvitegravir/cobicistat/emtricitabine/tenofovir DF also showed durable efficacy in terms of achieving sustained suppression of HIV-1 RNA levels to <50 copies/mL for up to 144 weeks in both of the phase III trials. Elvitegravir/cobicistat/emtricitabine/tenofovir DF is an important addition to the group of simplified once-daily single-tablet regimens currently available for the effective treatment of HIV-1 infection in antiretroviral therapy-naïve patients and is among the preferred regimens recommended for use as initial treatment. It offers advantages over more complex multiple-tablet regimens that may impair treatment adherence, which is fundamental to the successful management of HIV-1 infection.

    Topics: Adenine; Anti-HIV Agents; Carbamates; Deoxycytidine; Drug Combinations; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; HIV Infections; HIV-1; Humans; Organophosphonates; Quinolones; Tablets; Thiazoles

2014
Elvitegravir: a once-daily, boosted, HIV-1 integrase inhibitor.
    Expert review of anti-infective therapy, 2012, Volume: 10, Issue:1

    The development of HIV-1 integrase strand transfer inhibitors (INSTIs) has been a major therapeutic breakthrough in the management of HIV-1 infection. The first HIV-1 integrase inhibitor, raltegravir, was licensed in 2007 and was subsequently approved for use in treatment-naive patients. Since then, newer members of the INSTI class have been developed, including elvitegravir (EVG), which is in advanced clinical development and is being developed for use in both treatment-naive and treatment-experienced patients. EVG utilizes pharmacokinetic boosting to achieve adequate serum levels with once-daily dosing. Boosting agents with which it is being studied include ritonavir and cobicistat. In addition, EVG is being studied as a once-daily INSTI in a coformulated fixed-dose combination pill with the agents tenofovir disoproxil fumarate, emtricitabine and cobicistat (QUAD pill), which has the additional potential benefit of convenient once-daily dosing. The in vitro activity, pharmacokinetic and pharmacodynamic properties, results of Phase I-III clinical trials, resistance profile and drug-drug interactions of EVG will be reviewed in this article.

    Topics: Adenine; Carbamates; Clinical Trials, Phase I as Topic; Clinical Trials, Phase II as Topic; Clinical Trials, Phase III as Topic; Deoxycytidine; Drug Combinations; Drug Interactions; Drug Resistance, Viral; Drug-Related Side Effects and Adverse Reactions; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; HIV Infections; HIV Integrase Inhibitors; HIV-1; Humans; Organophosphonates; Quinolones; Randomized Controlled Trials as Topic; Thiazoles

2012
Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate single tablet for HIV-1 infection treatment.
    The Annals of pharmacotherapy, 2012, Volume: 46, Issue:12

    To review the clinical trials, pharmacologic characteristics, safety, and efficacy of the elvitegravir/cobicistat/emtricitabine/tenofovir single tablet formulation (Stribild).. Literature searches were performed in MEDLINE (1948-September 2012) and PubMed (1966-September 2012) using the search terms GS-9137, elvitegravir, GS 9350, cobicistat, quad pill, Stribild, and integrase inhibitors. Abstracts from HIV/AIDS conferences were reviewed.. Phase 3 studies evaluating the safety and efficacy of Stribild were preferentially evaluated, as well as relevant references from the published studies.. Stribild contains complete antiretroviral therapy for HIV-1 infection in a single tablet. It is the first once-daily therapy option available with an integrase inhibitor and a novel pharmacokinetic boosting agent. Stribild has shown noninferiority in viral load suppression at 48 weeks when compared with dual nucleoside/nucleotide reverse transcriptase inhibitor and either a ritonavir-boosted protease inhibitor or nonnucleoside reverse transcriptase inhibitor regimen. Stribild was well tolerated, but some patients experienced increases in serum creatinine early in treatment that stabilized over time.. Stribild is the first single-tablet regimen for HIV-1 infection treatment containing an integrase inhibitor. It is expected to have a prominent place in the formularies of health plans providing care for individuals with HIV-1 infection.

    Topics: Adenine; Anti-HIV Agents; Carbamates; Clinical Trials, Phase III as Topic; Deoxycytidine; Drug Combinations; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; HIV Infections; HIV Integrase Inhibitors; Humans; Organophosphonates; Quinolones; Tablets; Thiazoles; Viral Load

2012

Trials

3 trial(s) available for quad-pill and HIV-Infections

ArticleYear
A Trial of a Single-tablet Regimen of Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir Disoproxil Fumarate for the Initial Treatment of Human Immunodeficiency Virus Type 2 Infection in a Resource-limited Setting: 48-Week Results From Senegal, West A
    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2018, 10-30, Volume: 67, Issue:10

    There is an urgent need for safe and effective antiretroviral therapy (ART) for human immunodeficiency virus type 2 (HIV-2) infection. We undertook the first clinical trial of a single-tablet regimen containing elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate (E/C/F/TDF) to assess its effectiveness in HIV-2-infected individuals in Senegal, West Africa.. HIV-2-infected, ART-naive adults with World Health Organization stage 3-4 disease or CD4 count <750 cells/μL were eligible for this 48-week, open-label trial. We analyzed HIV-2 viral loads (VL), CD4 counts, clinical and adverse events, mortality, and loss to follow-up.. We enrolled 30 subjects who initiated E/C/F/TDF. Twenty-nine subjects completed 48 weeks of follow-up. The majority were female (80%). There were no deaths, no new AIDS-associated clinical events, and 1 loss to follow-up. The median baseline CD4 count was 408 (range, 34-747) cells/μL, which increased by a median 161 (range, 27-547) cells/μL at week 48. Twenty-five subjects had baseline HIV-2 VL of <50 copies/mL of plasma. In those with detectable HIV-2 VL, the median was 41 (range, 10-6135) copies/mL. Using a modified intent-to-treat analysis (US Food and Drug Administration Snapshot method), 28 of 30 (93.3%; 95% confidence interval, 77.9%-99.2%) had viral suppression at 48 weeks. The 1 subject with virologic failure had multidrug-resistant HIV-2 (reverse transcriptase mutation: K65R; integrase mutations: G140S and Q148R) detected at week 48. There were 8 grade 3-4 adverse events; none were deemed study related. Adherence and acceptability were good.. Our data suggest that E/C/F/TDF, a once-daily, single-tablet-regimen, is safe, effective, and well tolerated. Our findings support the use of integrase inhibitor-based regimens for HIV-2 treatment.. NCT02180438.

    Topics: Adult; Africa, Western; Aged; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Female; Health Resources; HIV Infections; HIV-1; Humans; Male; Middle Aged; Tablets; Young Adult

2018
Patient-Reported Symptoms over 48 Weeks in a Randomized, Open-Label, Phase 3b Non-inferiority Trial of Adults with HIV Switching to Coformulated Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir DF Versus Continuation of Ritonavir-Boosted Protease In
    The patient, 2015, Volume: 8, Issue:5

    Coformulated elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF; Stribild(®)) is a recommended integrase inhibitor-based regimen in treatment guidelines from the US Department of Health and Human Services and the British HIV Association. The purpose of this analysis was to determine the change in patient-reported symptoms over time among HIV-infected adults who switch to Stribild(®) versus those continuing on a protease inhibitor (PI) with FTC/TDF.. A secondary analysis was conducted on the STRATEGY-PI study (GS-US-236-0115, ClinicalTrials.gov NCT01475838), a randomized, open-label, phase 3b trial of HIV-infected adults taking a PI with FTC/TDF who were randomly assigned (2:1) either to Stribild(®) (switch) or continuation of their existing regimen (no-switch). Logistic regressions and longitudinal modeling were conducted to evaluate the relationship of treatment with bothersome symptoms.. At week 4 as compared with baseline, the switch group experienced a statistically significantly lower prevalence in five symptoms (diarrhea/loose bowels, bloating/pain/gas in stomach, pain/numbness/tingling in hands/feet, nervous/anxious, and trouble remembering). The lower prevalence of diarrhea/loose bowels, bloating/pain/gas in stomach, and pain/numbness/tingling in hands/feet observed at week 4 was maintained over time. While there were no significant differences between groups in the prevalence of sad/down/depressed and problems with sex at week 4 or week 48, longitudinal models indicated the switch group had a statistically significantly decreased prevalence in both symptoms from week 4 to week 48. As compared with the no-switch group, higher levels of satisfaction with treatment were experienced by patients in the switch group at the first follow-up visit and at week 24.. In this study sample, a switch from a ritonavir-boosted PI, FTC, and TDF regimen to coformulated EVG/COBI/FTC/TDF was associated with more treatment satisfaction and a reduction in the prevalence of patient-reported diarrhea/loose bowel symptoms, which was maintained over the 48-week study period.

    Topics: Adult; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Drug Combinations; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Emtricitabine; Female; HIV Infections; Humans; Logistic Models; Male; Patient Outcome Assessment; Patient Satisfaction; Protease Inhibitors; Ritonavir; Tenofovir

2015
A randomized double-blind comparison of coformulated elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate versus efavirenz/emtricitabine/tenofovir disoproxil fumarate for initial treatment of HIV-1 infection: analysis of week 96 results.
    Journal of acquired immune deficiency syndromes (1999), 2013, May-01, Volume: 63, Issue:1

    We report week 96 results from a phase 3 trial of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF, n = 348) vs efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF, n = 352). At week 48, EVG/COBI/FTC/TDF was noninferior to EFV/FTC/TDF (88% vs 84%, difference +3.6%, 95% confidence interval: -1.6% to 8.8%). Virologic success (HIV-1 RNA <50 copies/mL) was maintained at week 96 (84% vs 82%, difference +2.7%, 95% CI: -2.9% to 8.3%). Discontinuation due to adverse events was low (5% vs 7%). Median changes in serum creatinine (mg/dL) at week 96 were similar to week 48. These results support the durable efficacy and long-term safety of EVG/COBI/FTC/TDF.

    Topics: Adenine; Adult; Anti-HIV Agents; Carbamates; Creatinine; Deoxycytidine; Double-Blind Method; Drug Combinations; Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Female; HIV Infections; HIV-1; Humans; Male; Organophosphonates; Oxazines; Quinolones; RNA, Viral; Thiazoles; Treatment Outcome; Young Adult

2013

Other Studies

25 other study(ies) available for quad-pill and HIV-Infections

ArticleYear
Overdose of the HIV Medicine Genvoya® in Two Auto-Intoxications.
    Journal of analytical toxicology, 2023, Feb-21, Volume: 47, Issue:1

    Toxicological data on overdose with human immunodeficiency virus inhibitors are scarce. We present a case report of two independent suicide attempts by self-administered overdose with the same antiretroviral medicine Genvoya® (emtricitabine/elvitegravir/tenofovir alafenamide/cobicistat). Both patients were admitted to the hospital and presented with a loss of consciousness, lactic acidosis, elevated hepatic transaminase levels and hemodynamic instability. While one patient survived with advanced supportive measures, the other passed away. Emtricitabine levels were measured in vivo in various consecutive serum samples and postmortem urine, peripheral and cardiac serum samples and confirmed excessive use in both cases. This is the first time that emtricitabine levels following overdose are reported. Although measured concentrations for emtricitabine were quite similar in these cases, metabolic acidosis was more pronounced in the fatal case. The difference in outcomes between the two could be due to a difference in physiological status, susceptibility to accumulation and adverse effects, and perhaps a varying interval between ingestion and the start of supportive measures.

    Topics: Anti-HIV Agents; Drug Combinations; Drug Overdose; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Emtricitabine; HIV; HIV Infections; Humans

2023
[Case report about an initial diagnosis of HIV-infection in a young sailor through two AIDS-defining diseases with lethal progression].
    Deutsche medizinische Wochenschrift (1946), 2022, Volume: 147, Issue:20

    We saw a previously healthy 30-year-old Southeast-Asian sailor with progredient coughing and fever.. We found an atypical pneumonia along with a positive HIV-test. We performed a bronchial lavage and further diagnostics for opportunistic infections. The lab work showed a viral load of 3340 000 copies/ml and a CD4-cell-count of 36/µl.. HIV late presenter in CDC stadium C3 with Pneumocystis jirovecii and CMV pneumonia.. We treated with Meropenem, Moxifloxacin, Cotrimoxazol, Ganciclovir and Genvoya.. Due to a cardio-pulmonal deterioration invasive ventilation was necessary. In the end the patient died of multi organ failure twelve days after admission despite intensive care, hemodialysis and prone positioning.. This case demonstrates the difficulties in the pharmacotherapy and with drug interactions in a HIV late presenter with multi organ failure. Consultation and advice of the hospital pharmacy and the antibiotic stewardship team was vital for treating this patient. In the end cases like the portrayed should be treated in specialized clinics.. Wir sahen einen zuvor gesunden 30-jährigen südostasiatischen Seemann mit progredientem Husten und Fieber.  UNTERSUCHUNGEN:  Wir fanden eine atypische Pneumonie bei positivem HIV-Test. Im Verlauf erfolgten eine Bronchiallavage und weitere Untersuchungen zur Diagnostik etwaiger opportunistischer Infektionen. Das Labor zeigte eine Viruslast von 3340 000 Kopien/ml und eine CD4-Zellzahl von 36/µl.. HIV-„Late Presenter“ im CDC-Stadium C3 mit Pneumocystis jirovecii und CMV-Pneumonie.. Wir therapierten mit Meropenem, Moxifloxacin, Cotrimoxazol, Ganciclovir und Genvoya.. Es kam zu einer fulminanten kardiopulmonalen Verschlechterung, sodass die maschinelle Beatmung notwendig wurde. Letztendlich verstarb der Patient 12 Tage nach Aufnahme, trotz Intensivtherapie mit Dialyse und kinetischer Lagerungstherapie, am Multiorganversagen.. Dieser Fall zeigt die Schwierigkeiten der Pharmakotherapie und der Medikamenten-Interaktionen bei der Behandlung eines HIV-Late Presenter mit Multiorganversagen. Die Beratung durch die Krankenhausapotheke und das Antibiotic Stewardship Team war wesentlich für die Behandlung des Patienten. Letztendlich sollten solche Patienten in spezialisierten Zentren behandelt werden.

    Topics: Acquired Immunodeficiency Syndrome; Adult; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Ganciclovir; HIV Infections; Humans; Meropenem; Military Personnel; Moxifloxacin; Pneumonia, Pneumocystis

2022
Estimated changes in price discounts for tenofovir-inclusive HIV treatments following introduction of tenofovir alafenamide.
    AIDS (London, England), 2022, 12-01, Volume: 36, Issue:15

    We estimated list and net prices for tenofovir disoproxil fumarate (TDF) products Truvada, Complera, and Stribild, and their tenofovir alafenamide (TAF) versions Descovy, Odefsey, and Genvoya. Gilead offered discounts for Descovy that resulted into lower net prices compared to Truvada. This strategy encouraged patients switching from Truvada to Descovy before the availability of generic Truvada. Conversely, Gilead offered lower discounts for Odefsey and Genvoya, which resulted into higher net prices compared to Complera and Stribild.

    Topics: Anti-HIV Agents; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Emtricitabine, Rilpivirine, Tenofovir Drug Combination; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; HIV Infections; Humans; Tenofovir

2022
Single-tablet regimen of emtricitabine/tenofovir disoproxil fumarate plus cobicistat-boosted elvitegravir increase adherence for HIV postexposure prophylaxis in sexual assault victims.
    Sexually transmitted infections, 2021, Volume: 97, Issue:5

    Postexposure prophylaxis (PEP) is a recommended public health intervention after a sexual assault to prevent HIV infection.. We conducted a retrospective case-control study on how use of a single-tablet regimen (STR) of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild) affected adherence to PEP and attendance of a follow-up visit to the STI clinic compared with those who received a multitablet regimen (MTR). Data from sexual assault victims consulting for PEP were prospectively recorded between January 2011 and December 2017. Data were systematically collected on patient demographics, time of medical contact, source risk factors, type of exposure, attendance to follow-up visit, reported completion of PEP and adherence based on pharmacy records.. A total of 422 patients received PEP following a sexual assault, of whom 52% had documented completion of a 28-day PEP regimen and 71% attended a follow-up clinic visit. Patients who received an elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF)-based STR had a similar likelihood of attending their first follow-up visit (OR: 0.97; 95% CI: 0.64 to 1.48, p=0.90) but were more likely to complete the PEP regimen (OR: 1.70; 95% CI: 1.16 to 2.50, p=0.007). After adjusting for confounders, those who were prescribed an STR regimen were more likely to complete the PEP regimen (OR: 1.66, 95% CI: 1.09 to 2.53, p=0.019) than those who were prescribed an MTR such as stavudine/lamivudine/lopinavir/ritonavir or zidovudine/lamivudine/indinavir/ritonavir.. Sexual assault victims who were prescribed an STR based on EVG/COBI/FTC/TDF were more likely to complete PEP than those who were prescribed an MTR.

    Topics: Adult; Anti-HIV Agents; Belgium; Case-Control Studies; Crime Victims; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Female; HIV Infections; Humans; Male; Medication Adherence; Post-Exposure Prophylaxis; Retrospective Studies; Sex Offenses; Young Adult

2021
Impact of switching to TAF/FTC/RPV, TAF/FTC/EVG/cobi and ABC/3TC/DTG on cardiovascular risk and lipid profile in people living with HIV: a retrospective cohort study.
    BMC infectious diseases, 2021, Jun-22, Volume: 21, Issue:1

    We aimed to assess the overall cardiovascular and metabolic effect of the switch to three different single tablet regimens (STRs) [tenofovir alafenamide/emtricitabine/rilpivirine (TAF/FTC/RPV), TAF/FTC/elvitegravir/cobi (TAF/FTC/EVG/cobi) and ABC/lamivudine/dolutegravir (ABC/3TC/DTG)] in a cohort of people living with HIV/AIDS (PLWH) under effective ART.. All PLWH aged above 18 years on antiretroviral treatment with an HIV-RNA < 50 cp/mL at the time of the switch to TAF/FTC/RPV, TAF/FTC/EVG/cobi and ABC/3TC/DTG were retrospectively included in the analysis. Framingham risk score modification after 12 months from the switch such as lipid profile and body weight modification were assessed. The change from baseline to 12 months in mean cardiovascular risk and body weight in each of the STR's group were assessed by means of Wilcoxon signed-rank test whereas a mixed regression model was used to assess variation in lipid levels.. Five-hundred and sixty PLWH were switched to an STR regimen of whom 170 (30.4%) to TAF/FTC/EVG/cobi, 191 (34.1%) to TAF/FTC/RPV and 199 (35.5%) to ABC/3TC/DTG. No difference in the Framingham cardiovascular risk score was observed after 12 months from the switch in each of the STR's groups. No significant overtime variation in mean total cholesterol levels from baseline to 12 months was observed for PLWH switched to ABC/3TC/DTG [200 (SD 38) mg/dl vs 201 (SD 35) mg/dl; p = 0.610] whereas a significant increment was observed in PLWH switched to TAF/FTC/EVG/cobi [192 (SD 34) mg/dl vs 208 (SD 40) mg/dl; p < 0.0001] and TAF/FTC/RPV [187 (SD 34) mg/dl vs 195 (SD 35) mg/dl; p = 0.027]. In addition, a significant variation in the mean body weight from baseline to 12 months was observed in PLWH switched to TAF/FTC/EVG/cobi [72.2 (SD 13.5) kilograms vs 74.6 (SD 14.3) kilograms; p < 0.0001] and TAF/FTC/RPV [73.4 (SD 11.6) kilograms vs 75.6 (SD 11.8) kilograms; p < 0.0001] whereas no difference was observed in those switched to ABC/3TC/DTG [71.5 (SD 12.8) kilograms vs 72.1 (SD 12.6) kilograms; p = 0.478].. No difference in the cardiovascular risk after 1 year from the switch to these STRs were observed. PLWH switched to TAF/FTC/EVG/cobi and TAF/FTC/RPV showed an increase in total cholesterol levels and body weight 12 months after the switch.

    Topics: Adult; Anti-HIV Agents; Body Weight; Cohort Studies; Dideoxynucleosides; Drug Combinations; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Emtricitabine, Rilpivirine, Tenofovir Drug Combination; Female; Heart Disease Risk Factors; Heterocyclic Compounds, 3-Ring; HIV Infections; Humans; Italy; Lamivudine; Lipid Metabolism; Lipids; Male; Middle Aged; Oxazines; Piperazines; Pyridones; Retrospective Studies; Tablets

2021
Treatment with tenofovir alafenamide fumarate worsens the lipid profile of HIV-infected patients versus treatment with tenofovir disoproxil fumarate, each coformulated with elvitegravir, cobicistat, and emtricitabine.
    Basic & clinical pharmacology & toxicology, 2019, Volume: 124, Issue:4

    Two elvitegravir/cobicistat-based therapies combined with emtricitabine/tenofovir disoproxil fumarate (EVG/c/FTC/TDF) or emtricitabine/tenofovir alafenamide fumarate (EVG/c/FTC/TAF) are currently available for HIV patients. This study evaluated the modifications in the lipid profile of patients who received these treatments in the last three years at our institution. A retrospective observational study in HIV-infected patients who received EVG/c/FTC/TDF or EVG/c/FTC/TAF from January 2015 to January 2018 at a reference hospital in northwestern Spain was carried out. Epidemiological, clinical and immunovirological data were recorded. A statistical analysis was performed using SPSS software. A total of 384 EVG/c-based therapies were initiated during the study period, 151 EVG/c/FTC/TDF and 233 EVG/c/FTC/TAF. A significantly negative influence in all the lipid profile parameters in experienced patients and total cholesterol (TC), and LDL-C in naïve patients were observed after 48 weeks of treatment with EVG/c/FTC/TAF, while these parameters remained stable in the EVG/c/FTC/TDF group. During follow-up, a greater proportion of patients had lipid levels above the normal range (63.1% TC, 56.2% LDL-C) and new lipid-modifying drugs were prescribed (11.9%) in the EVG/c/FTC/TAF group. The number of cardiovascular risk factors (OR 1.66 [95% CI 1.01-2.72]; P = 0.043) was recognised as an independent predictor of lipid-lowering prescription for patients treated with both EVG/c/FTC/TDF and EVG/c/FTC/TAF. For patients treated with EVG/c/FTC/TAF, the mean total cholesterol to HDL ratio in the first 48 weeks of the study treatment was associated with a higher likelihood of lipid-lowering prescription in multivariate analysis (OR 1.6 [95% CI 1.12-2.52]; P = 0.011). Significant changes in lipid profile have been observed in patients who have received EVG/c/FTC/TAF. It was necessary to prescribe almost twice the number of lipid-lowering drugs to patients who received EVG/c/FTC/TAF (11.9%) vs EVG/c/FTC/TDF (4.7%).

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Cholesterol; Cholesterol, LDL; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Female; Follow-Up Studies; HIV Infections; Humans; Hypolipidemic Agents; Lipids; Male; Middle Aged; Retrospective Studies; Risk Factors; Spain; Tenofovir; Young Adult

2019
Severe rhabdomyolysis-induced acute kidney injury following concomitant use of Genvoya® (EVG/COBI/FTC/TAF) and simvastatin; a case report.
    BMC nephrology, 2019, 02-26, Volume: 20, Issue:1

    Genvoya® (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) is a recent single regimen for the treatment of Human Immunodeficiency Virus (HIV). However, because of its complexity, it is difficult to predict drug interactions, especially when associated with HMG-CoA reductase inhibitors and/or in the setting of other comorbidities. We discuss the mechanisms of these potential drug interactions as the cause of rhabdomyolysis and acute kidney injury in the context of prior and current medication therapy with possible underlying liver and kidney dysfunction.. We describe the case of a 54-year-old man diagnosed with HIV who developed severe rhabdomyolysis-induced anuric acute kidney injury (AKI) requiring renal replacement therapy following introduction of Genvoya® concomitantly with simvastatin, in the context of recently diagnosed hepatitis C and hepatitis A. Haemodialysis was continued over 5 weeks followed by progressive clinical and biological improvements. Five months later, a new antiretroviral regimen was started and has been well tolerated.. Simvastatin, as well as lovastatin, because of their CYP3A4 metabolism, and to a lesser extent atorvastatin, which is only partially metabolized by CYP3A4, are the HMG-CoA reductase inhibitors with the greatest risk of drug interactions and should not be used in patients under HIV-therapy. Patients receiving HMG-CoA reductase inhibitors should be monitored regularly for the occurrence of muscular adverse effects and drug interactions should be considered with each new prescription or change in clinical status. There are many online tools that enable clinicians to rapidly check for drug interactions. We recommend the one from the University of Liverpool for patients under HIV-therapy ( https://www.hiv-druginteractions.org/checker ), while for patients under hepatitis C-therapy, we advise to consult http://www.hep-druginteractions.org/ . This case illustrates the importance of multidisciplinary collaboration in the treatment of HIV-positive patients because of their complexity, associated comorbidities and the potential of multiple drug-drug interactions potentially exacerbated by underlying liver and/or kidney dysfunction.

    Topics: Acute Kidney Injury; Anti-HIV Agents; Cobicistat; Drug Combinations; Drug Interactions; Dyslipidemias; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Emtricitabine; Hepatitis A; Hepatitis C; HIV Infections; Humans; Hypolipidemic Agents; Liver Function Tests; Male; Middle Aged; Quinolones; Renal Dialysis; Rhabdomyolysis; Simvastatin; Tenofovir; Treatment Outcome

2019
The informal use of antiretroviral medications for HIV prevention by men who have sex with men in South Florida: initiation, use practices, medications and motivations.
    Culture, health & sexuality, 2018, Volume: 20, Issue:11

    Limited data suggest that some gay and other men who have sex with men are using antiretroviral medications informally, without a prescription, for HIV prevention. This qualitative study examined this phenomenon among gay and other men who have sex with men in South Florida. Participants initiated informal antiretroviral medication use as a means of protecting each other and because of the confidence in knowledge of antiretroviral medications shared by their friends and sex partners. The most commonly used medications included Truvada and Stribild. Motivations for use included condom avoidance, risk reduction, and fear of recent HIV exposure. Participants described positive and negative sentiments related to informal use, including concerns about informal antiretroviral medications offering sufficient protection against HIV, and limited knowledge about pre-exposure prophylaxis (PrEP). Because the antiretroviral medications used for PrEP have the potential to prevent HIV infection, future research must consider the informal antiretroviral medication use and related concerns, including adherence, diversion and viral resistance.

    Topics: Adolescent; Adult; Anti-HIV Agents; Condoms; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Florida; Health Knowledge, Attitudes, Practice; HIV Infections; Humans; Male; Middle Aged; Motivation; Pre-Exposure Prophylaxis; Qualitative Research; Risk Reduction Behavior; Self Medication; Sexual and Gender Minorities; Young Adult

2018
HIV-1 Proviral Sequence and Treatment Outcome of Virologically Suppressed Patients Switching to Coformulated Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate.
    Journal of acquired immune deficiency syndromes (1999), 2018, 09-01, Volume: 79, Issue:1

    Topics: Anti-HIV Agents; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; HIV Infections; HIV-1; Humans; Pilot Projects; Proviruses; Treatment Outcome; Viral Load

2018
A pharmacist-led medication switch protocol in an academic HIV clinic: patient knowledge and satisfaction.
    BMC infectious diseases, 2018, 07-06, Volume: 18, Issue:1

    Tenofovir alafenamide (TAF) is associated with less renal and bone toxicity compared with tenofovir disoproxil (TDF). TAF's recent FDA approval has spurred HIV providers to consider switching antiretroviral therapy (ART) regimens containing TDF to TAF to minimize long term risks. Patient views on the process of such medication switches have not been explored.. Patients taking elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) following the Food and Drug Administration's (FDA) approval of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) received medication education from an HIV pharmacist prior to switching to the tenofovir alafenamide (TAF) formulation. Patients were asked to complete a cross-sectional survey assessing satisfaction with the switch process and knowledge about the new medication 4 to 8 weeks post-switch.. Sixty five patients completed the switch and 57 (88%) completed a follow-up survey. Most (86%) reported understanding why the switch was made, while 91% correctly identified that TAF is associated with reduced renal toxicity, and 73% correctly identified that TAF is associated with reduced bone toxicity. No statistically significant difference was found in satisfaction with or understanding of why the medication switch was made when assessed by sex, age, race, or education, but there was a trend toward significance in the distribution of answers based on education level with those with a high school diploma, General Educational Development (GED) or less being more likely to be satisfied with the medication switch (p = 0.074).. Education from an ambulatory clinic-based HIV pharmacist resulted in high rates of patient satisfaction and understanding of the switch from TDF to TAF-containing ART.

    Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Cross-Sectional Studies; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Female; Health Knowledge, Attitudes, Practice; Health Surveys; HIV Infections; Humans; Male; Middle Aged; Patient Satisfaction; Pharmacists; Tenofovir

2018
Free and total plasma concentrations of elvitegravir/cobicistat during pregnancy and postpartum: a case report.
    British journal of clinical pharmacology, 2017, Volume: 83, Issue:12

    Topics: Adult; Anti-HIV Agents; Cobicistat; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Female; HIV Infections; Humans; Postpartum Period; Pregnancy; Quinolones

2017
Optimal HIV Postexposure Prophylaxis Regimen Completion With Single Tablet Daily Elvitegravir/Cobicistat/Tenofovir Disoproxil Fumarate/Emtricitabine Compared With More Frequent Dosing Regimens.
    Journal of acquired immune deficiency syndromes (1999), 2017, 08-15, Volume: 75, Issue:5

    The study evaluated elvitegravir/cobicistat/tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) ("Quad pill") for postexposure prophylaxis (PEP).. HIV-exposed individuals may benefit from PEP, but completion rates have been suboptimal because of regimen complexity and side effects. Newer antiretroviral combinations coformulated as single daily pills may optimize PEP adherence.. One hundred HIV-uninfected individuals who presented to a Boston community health center after an acute HIV sexual exposure were enrolled and initiated PEP with the daily, single-pill combination Quad pill for a 28-day course.. Side effects and medication completion rates from study participants were compared with historical controls who had used PEP regimens consisting of TDF/FTC daily and raltegravir twice daily, or earlier regimens of twice daily zidovudine (AZT)/lamivudine (3TC) and a protease inhibitor, using χ tests for independence.. Of the 100 participants who initiated the Quad pill for PEP after a high-risk sexual exposure, 71% completed the 28-day Quad pill regimen, which was significantly greater than historical controls who used TDF/FTC and raltegravir (57%, P < 0.05) or AZT/3TC plus a protease inhibitor (39%, P < 0.001). The most common side effects reported by Quad pill users were as follows: abdominal discomfort or pain, gas or bloating (42%), diarrhea (38%), fatigue (28%), nausea or vomiting (28%), headache (14%), or dizziness or lightheadedness (6%). Most symptoms were mild, limited, and did not result in medication discontinuation. No participants became HIV infected.. Fixed-dose combination of elvitegravir/cobicistat/TDF/FTC was safe and well tolerated for PEP, with higher regimen completion rates than more frequently dosed PEP regimens.

    Topics: Adult; Anti-HIV Agents; Boston; CD4 Lymphocyte Count; Drug Administration Schedule; Drug Therapy, Combination; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Female; HIV Infections; Humans; Male; Medication Adherence; Post-Exposure Prophylaxis; Prospective Studies; Treatment Outcome; Viral Load

2017
A severe hypersensitivity reaction to abacavir following re-challenge.
    International journal of STD & AIDS, 2017, Volume: 28, Issue:3

    We report this case to highlight the possibility of a severe hypersensitivity reaction as an important potential consequence of couples, living with HIV, sharing anti-retroviral treatment. An HIV-1 positive and carrier of HLA-B*57:01 allele, treatment experienced man was commenced one pill Regimen Stribild (tenofovir, emtricitabine, elvitegravir and cobicistat) in July 2015. On running short of medication, he admitted to sharing his partner's treatment (Triumeq; abacavir, lamivudine and dolutegravir). On the second occasion, re-introduction resulted in whole body rash 4 h post dose and was associated with fever, respiratory symptoms, headache and vomiting. On examination, he was pyrexic, tachyponeic, tachycardiac and hypotensive. Hypersensitivity to abacavir can cause significant morbidity. Re-challenge can result in a more rapid, severe and potentially life-threatening reaction. This potentially could become an increasing problem with more couples, living with HIV, sharing medication.

    Topics: Anti-HIV Agents; Dideoxynucleosides; Drug Combinations; Drug Hypersensitivity; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Heterocyclic Compounds, 3-Ring; HIV Infections; HIV-1; HLA-B Antigens; Humans; Lamivudine; Oxazines; Piperazines; Pyridones

2017
Co-administration of elvitegravir/cobicistat/tenofovir disoproxil fumarate/emtricitabine and atazanavir in treatment-experienced HIV patients.
    International journal of STD & AIDS, 2017, Volume: 28, Issue:8

    We report the use of elvitegravir 150 mg/cobicistat 150 mg/tenofovir disoproxil fumarate 300 mg/emtricitabine 200 mg (EVG/COBI/TDF/FTC) once daily, in addition to once-daily atazanavir (ATV) 300 mg, in treatment-experienced patients with human immunodeficiency virus (HIV). Due to limited data available on the co-administration of these agents, our objective was to evaluate and monitor safety and efficacy of this regimen in patients who developed resistance or intolerance to conventional antiretroviral therapy (ART). This short report included offenders incarcerated in the Illinois Department of Corrections who were ≥18 years, HIV-infected, had documented antiretroviral resistance, and received EVG/COBI/TDF/FTC + ATV once daily. Based on previous ART, resistance patterns and current medications, seven patients were initiated on once-daily therapy consisting of EVG/COBI/TDF/FTC and ATV. Due to extensive resistance, two of the seven patients were also started on abacavir (ABC) 600 mg daily in addition to EVG/COBI/TDF/FTC and ATV. Of the seven patients, one had ART changed due to concerns of resistance based on a genotype, one experienced a decline in renal function that warranted a change in therapy, and one is currently virologically suppressed on a combination of EVG/COBI/TDF/FTC, ATV, and ABC. The remaining four patients remain virologically suppressed on EVG/COBI/TDF/FTC + ATV. Therapy consisting of EVG/COBI/TDF/FTC and ATV may be a viable option for some treatment-experienced HIV-infected patients. Further studies evaluating the safety, efficacy, and pharmacokinetics of this therapy are warranted, given the lack of information currently available.

    Topics: Adult; Anti-HIV Agents; Atazanavir Sulfate; Drug Combinations; Drug Therapy, Combination; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Female; HIV Infections; HIV Protease Inhibitors; Humans; Male; Middle Aged; Treatment Outcome

2017
Virological failure in two patients with HIV-1 RNA viral loads >1,000,000 copies/ml initiated on elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate.
    Antiviral therapy, 2016, Volume: 21, Issue:2

    Very high baseline HIV-1 RNA viral loads require potent and robust antiretroviral regimens to achieve virological suppression. The coformulated single tablet regimen of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF) is recommended by the US Department of Health and Human Services for the treatment of HIV-1 in treatment-naive adults and adolescents regardless of baseline CD4(+) T-cell count and viral load. We report two cases of HIV-infected, treatment-naive patients, with baseline HIV-1 RNA viral loads >1,000,000 copies/ml who were initiated on the single tablet regimen EVG/COBI/FTC/TDF, but failed to attain viral load suppression and developed resistance to the components of EVG/COBI/FTC/TDF.

    Topics: Anti-HIV Agents; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Female; HIV Infections; HIV-1; Humans; Male; Middle Aged; RNA, Viral; Viral Load

2016
Genvoya--a new 4-drug combination for HIV.
    The Medical letter on drugs and therapeutics, 2016, Feb-15, Volume: 58, Issue:1488

    Topics: Cobicistat; Drug Combinations; Drug Interactions; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Emtricitabine; HIV Infections; HIV Integrase Inhibitors; HIV-1; Humans; Quinolones; Randomized Controlled Trials as Topic; Tenofovir; Treatment Outcome

2016
Single-tablet antiretroviral treatment (once daily).
    CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne, 2016, Sep-20, Volume: 188, Issue:13

    Topics: Anti-HIV Agents; CD4 Lymphocyte Count; Dideoxynucleosides; Drug Combinations; Drug Hypersensitivity; Drug Interactions; Drug Resistance, Viral; Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Emtricitabine, Rilpivirine, Tenofovir Drug Combination; Heterocyclic Compounds, 3-Ring; HIV Infections; Humans; Lamivudine; Mental Disorders; Oxazines; Piperazines; Pyridones; Viral Load

2016
Safety and Tolerability of Stribild in the Southeast United States.
    Journal of the International Association of Providers of AIDS Care, 2016, Volume: 15, Issue:5

    The purpose of this study is to assess postmarketing safety and tolerability of Stribild (elvitegravir [EVG]/cobicistat [COBI]/tenofovir disoproxil fumarate [TDF]/emtricitabine [FTC]).. A retrospective, pharmacoepidemiologic study in 2 outpatient HIV clinics in the Southeast United States was conducted among adults receiving EVG/COBI/TDF/FTC. We evaluated incidence and treatment-related adverse events, including change in serum creatinine (SCr).. Patients were primarily treatment experienced (n = 173, 60%), African American (n = 210, 73%), and males (n = 187, 65%). One hundred ninety-five (68%) patients had any increase in SCr, and 65 (23%) had an increase of ≥0.3 mg/dL. Mean SCr change from baseline to peak was 0.2 mg/dL. Being treatment experienced (odds ratio [OR] = 2.21, 95% confidence interval [CI]: 1.12-4.38) was associated with SCr ≥0.3 mg/dL, while body mass index ≥30 kg/m(2) (OR = 0.41, 95% CI: 0.18-0.93) was protective. Twenty (7%) patients discontinued therapy, 3 due to acute kidney injury.. Our results demonstrate limited adverse events and low discontinuation rates associated with EVG/COBI/TDF/FTC.

    Topics: Adult; Anti-HIV Agents; Creatinine; Drug-Related Side Effects and Adverse Reactions; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Female; HIV Infections; Humans; Kidney Function Tests; Male; Middle Aged; Retrospective Studies; Southeastern United States

2016
When food can make the difference: The case of elvitegravir-based co-formulation.
    International journal of pharmaceutics, 2016, Oct-15, Volume: 512, Issue:1

    Stribild should be administered under fed conditions to optimize drugs exposure. Here we assessed to what extent this advice is applied in the real life scenario by therapeutic drug monitoring in 75 HIV-infected patients given Stribild-based antiretroviral therapy. Fifty-three percent of our patients took Stribild at lunch/supper time, 23% in the morning with breakfast, and 24% middle in the morning or late in the evening. Twelve out of the 75 patients had unquantifiable elvitegravir concentrations, whereas in the remaining the levels were largely distributed. Wide inter-individual variability in the tenofovir, cobicistat and darunavir trough concentrations was also observed. In real life settings a significant proportion of patients took Stribild without food, namely in the mid-morning or late in the evening. This resulted in a wide inter-individual variability of antiretroviral drug trough concentrations. To avoid the risk for patients to experience suboptimal drug exposure, it is important that health professionals more convincingly advise their patients to take Stribild in fed conditions. On the other hand, the role of patient education and patient responsibility to correctly take the therapy should not be underestimated.

    Topics: Anti-HIV Agents; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Female; Food-Drug Interactions; HIV Infections; Humans; Individuality; Male; Retrospective Studies

2016
Evaluation of tolerability with the co-formulation elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate for post-HIV exposure prophylaxis.
    BMC infectious diseases, 2016, 11-29, Volume: 16, Issue:1

    The preferred regimen for HIV post-exposure prophylaxis (PEP) is based mainly on safety and tolerability because it is given to immunocompetent people without HIV infection for a limited time (28 days). The frequency of adverse events (AEs) may be > 60%. Although AEs are generally not severe, they can lead to lack of adherence and failure to complete the regimen. We evaluated the co-formulation elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate (Stribild. This was a prospective cohort study conducted in one hospital in Paris (April to December 2015. Each participant receiving the PEP treatment (FTC-150 mg/TDF-245 mg/elvitegravir-200 mg/cobicistat 150 mg once daily) at the pharmacy of the hospital were recruited consecutively. A clinical visit was planned at 8 weeks after sexual exposure. Reminders were sent to participants who missed the appointment. A standardized questionnaire was administered to evaluate completeness and tolerability at week 8.. Overall, 284 participants (86% men; 80% MSM; median age 30 years) were prescribed Stribild. Stribild

    Topics: Adolescent; Adult; Aged; Anti-HIV Agents; Cobicistat; Drug Combinations; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Female; HIV Infections; Homosexuality, Male; Humans; Male; Medication Adherence; Middle Aged; Paris; Post-Exposure Prophylaxis; Prospective Studies; Sexual Behavior; Young Adult

2016
A 68-year old male presenting with rhabdomyolysis-associated acute kidney injury following concomitant use of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate and pravastatin/fenofibrate: a case report.
    Journal of medical case reports, 2015, Sep-08, Volume: 9

    We present what we believe to be the first case in the literature of rhabdomyolysis-induced renal failure caused by a probable drug interaction between elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF) and pravastatin/fenofibrate.. A 68-year old Caucasian man presented with progressive pain in both legs two weeks after commencing treatment with EVG/COBI/FTC/TDF. He was found to have biochemical evidence of rhabdomyolysis and acute renal failure.. We emphasize the need for post marketing surveillance of adverse effects of new products. Pharmacokinetic studies are necessary to investigate the levels of pravastatin in patients taking COBI and fenofibrate with and without other comorbidities. Meanwhile, we suggest that creatine kinase levels should be monitored and patients advised to report myalgias when using concomitant EVG/COBI/FTC/TDF and pravastatin/fenofibrate. This case serves as an important reminder to use estimated glomerular filtration rates rather than serum creatinine levels when choosing new medications. If potentially nephrotoxic combinations are started in patients with borderline estimated glomerular filtration rates, it may be prudent to check these filtration rates more frequently than usual. In patients with reduced estimated glomerular filtration rates, potentially nephrotoxic combinations should be avoided wherever possible.

    Topics: Acute Kidney Injury; Aged; Anti-HIV Agents; Anticholesteremic Agents; Drug Interactions; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Fenofibrate; HIV Infections; Humans; Hypolipidemic Agents; Male; Pravastatin; Rhabdomyolysis

2015
The elvitegravir Quad pill: the first once-daily dual-target anti-HIV tablet.
    Expert opinion on investigational drugs, 2012, Volume: 21, Issue:7

    Anti-HIV combination therapies in a single formulation currently target only HIV-1 reverse transcriptase via two different mechanisms of action by associating a nucleoside and a non-nucleoside reverse transcriptase inhibitor. These combination therapies are therefore referred to as multi-class combination products. The elvitegravir Quad pill (Gilead Sciences), when approved by the Food and Drug Administration for the treatment of HIV/AIDS, will become the first once-daily dual-target anti-HIV tablet. This "4 in 1" tablet targets HIV-1 integrase by elvitegravir boosted by the pharmaco-enhancer cobicistat and HIV-1 reverse transcriptase by the two nucleoside reverse transcriptase inhibitors emtricitabine + tenofovir disoproxil fumarate. A second pill referred to as the 572-Trii pill (Shionogi-ViiV Healthcare, LLC), also based on the dual inhibition of integrase and reverse transcriptase, is currently in late-phase clinical trials. The availability of these novel once-daily anti-HIV tablets will improve treatment adherence and offer new perspective for patient failing existing antiviral regimens.

    Topics: Adenine; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Carbamates; Clinical Trials as Topic; Deoxycytidine; Drug Administration Schedule; Drug Combinations; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; HIV Infections; Humans; Organophosphonates; Quinolones; Tablets; Thiazoles

2012
Elvitegravir/cobicistat, mirabegron, and linaclotide.
    Journal of the American Pharmacists Association : JAPhA, 2012, Volume: 52, Issue:6

    Topics: Acetanilides; Adenine; Anti-Retroviral Agents; Carbamates; Constipation; Deoxycytidine; Drug Combinations; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; HIV Infections; HIV-1; Humans; Organophosphonates; Peptides; Quinolones; Thiazoles; Urinary Bladder, Overactive

2012
Novel HIV-1 treatment Stribild™ gains regulatory approval.
    Expert review of clinical pharmacology, 2012, Volume: 5, Issue:6

    Topics: Adenine; Anti-HIV Agents; Carbamates; Deoxycytidine; Drug Approval; Drug Combinations; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; HIV; HIV Infections; Humans; Organophosphonates; Quinolones; Thiazoles

2012
Improved adherence expected with new HIV combo treatment.
    Managed care (Langhorne, Pa.), 2012, Volume: 21, Issue:11

    Topics: Adenine; Aged; Aged, 80 and over; Anti-HIV Agents; Carbamates; Deoxycytidine; Drug Combinations; Drug Labeling; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; HIV Infections; Humans; Medication Adherence; Middle Aged; Organophosphonates; Quinolones; Randomized Controlled Trials as Topic; Thiazoles; United States

2012