gs-7340 and Weight-Gain

A growing body of evidence suggests that integrase inhibitors (INSTIs) are significantly associated with weight gain and obesity. Obesity is a significant risk factor for metabolic syndrome and diabetes. This article comprehensively reviews recent available evidence weight gain and the risks of metabolic syndrome and diabetes associated with INSTIs.. Recent evidence continues to contribute to the evidence for weight gain associated with INSTIs, especially when used with newer nucleoside reverse transcriptase inhibitor, tenofovir alafenamide (TAF). Although the literature suggests a neutral effect on lipids, there is evidence that INSTIs are associated with metabolic syndrome due to treatment-emergent obesity. The literature for short-term treatment-emergent diabetes and insulin resistance remains inconsistent, but there is some evidence that weight gain could lead to an increased risk of developing diabetes in the future.. Longer term studies are required to understand the metabolic impact of INSTIs, secondary to weight gain. Evidence suggests that INSTIs, when used with TAF, contribute to metabolic syndrome and may have long-term risks of diabetes. INSTIs, when used with tenofovir disoproxil fumarate, have fewer metabolic implications. Clinicians must monitor for weight gain and metabolic effects, especially in those with underlying risk factors.

Topics: Alanine; Anti-HIV Agents; Diabetes Mellitus; HIV Infections; HIV Integrase Inhibitors; Humans; Metabolic Syndrome; Tenofovir; Weight Gain

Obesity is increasing in people with HIV (PWH). This review aims to summarise the recent evidence investigating the associations between the use of integrase inhibitors and tenofovir alafenamide (TAF) with weight gain and the mechanisms by which this may occur. Understanding the role that antiretroviral therapies play in promoting weight gain is critical in making informed treatment decisions.. Weight gain is common with antiretroviral therapies and can lead to significant medical complications for PWH. Antiretroviral regimens containing an integrase inhibitor in conjunction with TAF are associated with the greatest degree of weight gain. This weight gain is greatest with dolutegravir and bictegravir compared with other integrase inhibitors. Some of the measured weight gain attributed to TAF may actually reflect a loss of weight suppressant effects of tenofovir disoproxil fumarate, and thus the exact proportional contribution of TAF remains to be seen. The mechanisms by which advent of antiretroviral therapy may be promoting weight gain is still being determined but underlying genetic risks factors and gender are very important determinants of the degree of weight gained.. Integrase inhibitors and TAF contribute to weight gain in PWH. This places them at risk for potentially serious medical complications.

Topics: Alanine; Anti-HIV Agents; HIV Infections; HIV Integrase Inhibitors; Humans; Tenofovir; Weight Gain

In TANGO, switching to dolutegravir/lamivudine was noninferior at 48 weeks to continuing 3-/4-drug tenofovir alafenamide-based regimens in virologically suppressed individuals with HIV-1. Antiretroviral agents have been associated with weight gain and metabolic complications.. One hundred thirty-four centers; 10 countries.. We assessed weight; fasting lipids, glucose, and insulin; and prevalence of insulin resistance and metabolic syndrome at baseline and week 48 in TANGO participant subgroups by boosting agent use in baseline regimens (boosted and unboosted).. In each treatment group, 74% of participants used boosted regimens at baseline. In boosted and unboosted subgroups, weight and fasting glucose changes at week 48 were small and similar between treatment groups. Overall and in the boosted subgroup, greater decreases from baseline were observed with dolutegravir/lamivudine in fasting total cholesterol (P < 0.001), low-density lipoprotein cholesterol (P < 0.001), triglycerides (P < 0.001), total cholesterol/high-density lipoprotein cholesterol ratio (overall, P = 0.017; boosted, P = 0.007), and insulin (boosted, P = 0.005). Prevalence of HOMA-IR ≥2 was significantly lower at week 48 with dolutegravir/lamivudine overall [adjusted odds ratio (aOR), 0.59; 95% confidence interval (CI), 0.40 to 0.87; P = 0.008] and in the boosted subgroup [aOR, 0.56; 95% CI, 0.36 to 0.88; P = 0.012] but not in the unboosted subgroup [aOR, 0.70; 95% CI, 0.31 to 1.58; P = 0.396]. Prevalence of metabolic syndrome at week 48 was low and consistent between treatment groups overall, with differences trending to favor dolutegravir/lamivudine in the unboosted subgroup [aOR, 0.41; 95% CI, 0.15 to 1.09; P = 0.075].. Generally, switching from 3-/4-drug tenofovir alafenamide-based regimens to dolutegravir/lamivudine improved metabolic parameters, particularly when switching from boosted regimens. Because of smaller sample size in the unboosted subgroup, results warrant further investigation.

Topics: Adult; Alanine; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Blood Glucose; Drug Therapy, Combination; Heterocyclic Compounds, 3-Ring; HIV Infections; HIV-1; Humans; Insulin Resistance; Lamivudine; Lipids; Metabolic Syndrome; Oxazines; Piperazines; Pyridones; Tenofovir; Viral Load; Weight Gain

Topics: Adenine; Anti-HIV Agents; Cholesterol; Drug Combinations; Emtricitabine; Heterocyclic Compounds, 3-Ring; HIV Infections; Humans; Weight Gain

We aimed to determine the reversibility of at least 7% weight gain within 12 months following tenofovir alafenamide (TAF) and/or integrase strand transfer inhibitor (INSTI) discontinuation in people with HIV (PWH) from the Dutch ATHENA cohort.. PWH with at least 7% weight gain within 24 months after first switch to TAF and/or INSTI whilst being virally suppressed were selected, excluding those with comorbidities/co-medication known to be associated with weight gain. PWH who discontinued only TAF, only INSTI or TAF+INSTI, with available follow-up weight, were included. Mean weight change in the 24 months prior to and 12 months after discontinuation was modelled using mixed-effects linear regression. Factors associated with yearly weight change were assessed using linear regression.. In 115 PWH, discontinuing only TAF ( n  = 39), only INSTI ( n  = 53) or TAF+INSTI ( n  = 23), the adjusted mean modelled weight change in the 24 months prior to discontinuation was +4.50 kg [95% confidence interval (CI) 3.04-6.10], +4.80 kg (95% CI 2.43-7.03) and +4.13 kg (95% CI 1.50-7.13), respectively, and -1.89 kg (95% CI -3.40 to -0.37), -1.93 kg (95% CI -3.92 to +0.07) and -2.55 kg (95% CI -5.80 to +0.02) in the 12 months postdiscontinuation. A greater number of years since HIV diagnosis was associated with greater reversibility of weight gain. No associations were found between weight change postdiscontinuation and changes in NRTI backbone or anchor agent at moment of discontinuation.. There was no evidence of rapid reversibility of at least 7% TAF-associated and/or INSTI-associated weight gain after discontinuation of these agents. Studies of larger and more diverse populations of PWH are required to more fully understand the degree to which weight gain is reversible when discontinuing TAF and/or INSTI.

Topics: Adult; Alanine; Anti-Retroviral Agents; Drug Therapy, Combination; Female; HIV Infections; Humans; Male; Middle Aged; Tenofovir; Virus Integration; Weight Gain

Treatment with tenofovir alafenamide fumarate (TAF) is associated with body weight gain. However, little or no information is available on this issue in Asian populations.. This single-center retrospective study included Japanese people living with HIV (PLWH) who satisfied the following criteria; 1) switching from TDF to TAF after HIV-suppression, 2) follow-up for ≥2 years while on TDF and TAF, and 3) no switching of the third antiretroviral agent. Changes in annual body weight and lipid profiles were compared between the TDF and TAF periods.. Of 328 patients, dolutegravir (DTG) was used in 118 PLWH. Overall, no significant difference in weight gain was observed between TDF and TAF (0.76 vs. 0.9 kg/year, p = 0.331). In TAF-period, younger (<50 years of age) group showed significantly greater weight gain than older group (1.03 vs. 0.12 kg/year, p = 0.037). In DTG group, weight gain was larger in TAF-period (0.74 vs. 1.31 kg/year, p = 0.046), especially in younger subgroup (1.43 kg/year) compared with older one (-0.12 kg/year). Multivariate regression analysis showed that TAF was not associated with weight gain (estimates 0.201, p = 0.170) except for DTG group, whereas young age was associated with weight gain in all subjects (estimates -0.033/1 year older, p < 0.001), DTG, RAL, and EFV groups.. In Japanese PLWH, annual body weight change was comparable in TDF- and TAF-period, while TAF plus DTG correlated with weight gain. Since young age was a key determinant of weight change, careful interpretation is needed for TAF-associated weight gain.

Topics: Adult; Drug Substitution; East Asian People; HIV Infections; Humans; Retrospective Studies; Tenofovir; Weight Gain

Topics: Alanine; Amides; Anti-HIV Agents; Dideoxynucleosides; Emtricitabine; Heterocyclic Compounds, 3-Ring; HIV Infections; HIV-1; Humans; Lamivudine; Oxazines; Piperazines; Pyridones; Tenofovir; Weight Gain

Switching from tenofovir disoproxil fumarate (TDF)- to tenofovir alafenamide (TAF)-containing antiretroviral therapy may negatively influence weight, cholesterol, and atherosclerotic cardiovascular disease risk. The extent of these changes and their association with TAF remain unclear.. This retrospective cohort evaluated metabolic changes in virologically suppressed patients with HIV infection who switched from TDF to TAF without switching other antiretroviral therapy medications. Adult patients on TDF and with no HIV viral load values >200 copies/mL for ≥2 years prior to and following a TAF switch were included. Weight and other variables were collected for 2 years before and after the switch. Longitudinal linear mixed-effects models evaluated changes at 1 and 2 years after the switch.. In the unadjusted analysis, there were increases in weight, BMI, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides, systolic blood pressure, fasting glucose, and atherosclerotic cardiovascular disease risk scores 2 years after switching to TAF (each p ≤ 0.03). However, only increases in total and low-density lipoprotein cholesterol were associated with TAF and were significantly different from expected changes predicted in the adjusted longitudinal models.. Despite observing significant unadjusted metabolic changes after switching to TAF, only changes in cholesterol were associated with TAF and were different from changes expected in time-trend adjusted models.

Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Cardiovascular Diseases; Cholesterol; Drug Substitution; Fumarates; HIV Infections; Humans; Retrospective Studies; Sustained Virologic Response; Tenofovir; Weight Gain

Switching from tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide (TAF) increases low-density lipoprotein cholesterol (LDL-C) and body weight. Metabolic effects of the opposite TAF-to-TDF switch are unknown.. To investigate the effect of TAF-to-TDF switch on plasma lipids, body weight, and atherosclerotic cardiovascular disease (ASCVD) risk score.. A retrospective chart review.. One hundred and forty-six patients with TAF-to-TDF switch (Switch group) were compared with 146 patients matched for sex, age, and third antiretroviral agent class who continued unchanged TAF-containing regimen (Control group). Data were collected at approximately 1 year (follow-up FU-1) and 2 years (follow-up FU-2) after baseline values.. In Switch group at FU-1, total cholesterol (TC) and LDL-C decreased 12.1% and 12.4% ( P  < 0.001 in both), respectively. High-density lipoprotein cholesterol (HDL-C) also decreased 8.2% ( P  < 0.001) in Switch group, but TC/HDL-C ratio did not change. No statistically significant changes were observed in Control group in any lipid values. TC remained similarly decreased through FU-2 in Switch group, but LDL-C increased from FU-1 to FU-2 in both groups. ASCVD risk score decreased from 6.3% at baseline to 6.0% at FU-2 ( P  = 0.012) in Switch group but increased from 8.4 to 9.1% ( P  = 0.162) in Control group. Body weight increased from 83.4 kg at baseline to 84.9 kg at FU-2 ( P  = 0.025) in Control group but remained stable in Switch group (83.1-83.7 kg, P  = 0.978).. TAF-to-TDF switch improved plasma lipid profile and ASCVD risk score, as well as prevented weight gain, when compared with ongoing TAF-based antiretroviral therapy.

Topics: Alanine; Anti-HIV Agents; Cholesterol, LDL; Drug Substitution; HIV Infections; Humans; Retrospective Studies; Tenofovir; Weight Gain

Several studies have reported weight gain after switching to integrase strand transfer inhibitor (INSTI)-based antiretroviral therapy (ART). Debate persists if weight gain also occurs when switching from tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide (TAF)-based ART.. We performed a retrospective chart review of virally suppressed HIV-infected patients who were switched from non INSTI- to INSTI-based ART (INSTI switch group) as well as patients switched from TDF- to TAF-based ART (TAF switch group), and compared the mean weight change in these groups to the mean change in weight in patients maintained on NNRTI-based regimens (control group).. 329 patients were identified. 256 patients in the INSTI switch group gained a mean 2.4 kg over 17 months compared to 0.5 kg in 54 patients in the control group over the same period (p = 0.008). 161 patients in the TAF switch group gained a mean 2.8 kg over 17 months compared to 0.5 kg in the control group (p = 0.003). There was no statistical difference in weight gain between the INSTI and TAF switch groups. Although the highest mean weight gain of 3.2 kg was seen in those 90 patients switched from both TDF- to TAF-based and non INSTI- to INSTI-based ART (TAF/INSTI switch group), this weight gain was not statistically different compared with the INSTI switch or TAF switch groups.. Our study suggests that weight gain is associated with both switching HIV regimens from non INSTI- to INSTI-based ART and TDF- to TAF-based ART.

Topics: Alanine; Anti-HIV Agents; Drug Substitution; HIV Infections; Humans; Integrase Inhibitors; Retrospective Studies; Tenofovir; Weight Gain

As cardiovascular diseases represent the main cause of non-AIDS related death in people living with HIV (PLWH) with undetectable viral load, we evaluated lipid profile, weight gain and calculated cardiovascular risk change after switching from tenofovir disoproxil fumarate (TDF)-based regimens to tenofovir alafenamide (TAF)-based regimens.. Switching from TDF to TAF resulted in a significant increase in triglycerides levels, total cholesterol and HDL cholesterol. LDL cholesterol and total cholesterol/HDL ratio did not show significant changes. Calculated cardiovascular risk increased after switch from TDF- to TAF-based therapy.. Together with favorable outcomes at the bone and kidney levels, potential negative impact of TAF on lipid profile should be included in the reflection to propose the most appropriate and tailored ARV treatment.

Topics: Alanine; Anti-HIV Agents; Cardiovascular Diseases; Heart Disease Risk Factors; HIV Infections; Humans; Lipids; Retrospective Studies; Risk Factors; Tenofovir; Weight Gain

Evaluate differences in weight change by regimen among people living with HIV (PLWH) initiating antiretroviral therapy (ART) in the current era.. Between 2012 and 2019, 3232 ART-naïve PLWH initiated ≥3-drug ART regimens in 8 Centers for AIDS Research Network of Integrated Clinical Systems sites. We estimated weight change by regimen for 11 regimens in the immediate (first 6 months) and extended (all follow-up on initial regimen) periods using linear mixed models adjusted for time on regimen, interaction between time and regimen, age, sex, race/ethnicity, hepatitis B/C coinfection, nadir CD4, smoking, diabetes, antipsychotic medication, and site. We included more recently approved regimens [eg, with tenofovir alafenamide fumarate (TAF)] only in the immediate period analyses to ensure comparable follow-up time.. Mean follow-up was 1.9 years on initial ART regimen. In comparison to efavirenz/tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC), initiating bictegravir/TAF/FTC {3.9 kg [95% confidence interval (CI): 2.2 to 5.5]} and dolutegravir/TAF/FTC [4.4 kg (95% CI: 2.1 to 6.6)] were associated with the greatest weight gain in the immediate period, followed by darunavir/TDF/FTC [3.7 kg (95% CI: 2.1 to 5.2)] and dolutegravir/TDF/FTC [2.6 kg (95% CI: 1.3 to 3.9)]. In the extended period, compared with efavirenz/TDF/FTC, initiating darunavir/TDF/FTC was associated with a 1.0 kg (95% CI: 0.5 to 1.5) per 6-months greater weight gain, whereas dolutegravir/abacavir/FTC was associated with a 0.6-kg (95% CI: 0.3 to 0.9) and dolutegravir/TDF/FTC was associated with a 0.6-kg (95% CI: 0.1 to 1.1) per 6-months greater gain. Weight gain on dolutegravir/abacavir/FTC and darunavir/TDF/FTC was significantly greater than that for several integrase inhibitor-based regimens.. There is heterogeneity between regimens in weight gain following ART initiation among previously ART-naïve PLWH; we observed greater gain among PLWH taking newer integrase strand transfer inhibitors (DTG, BIC) and DRV-based regimens.

Topics: Adult; Alanine; Alkynes; Anti-HIV Agents; Anti-Retroviral Agents; Benzoxazines; Cyclopropanes; Dideoxynucleosides; Female; Heterocyclic Compounds, 3-Ring; HIV Infections; HIV Integrase Inhibitors; Humans; Male; Middle Aged; Oxazines; Piperazines; Pyridones; Tenofovir; Weight Gain

HIV integrase strand transfer inhibitors (INSTI) are considered well tolerated with few treatment-limiting adverse effects. However, emerging data from clinical trials has identified excessive weight gain possibly due to INSTI alone or with tenofovir alafenamide as a new and possible long-term complication of combination antiretroviral therapy (cART). Identifying who is at greatest risk and whether the unintended weight gain is reversible remain unanswered questions. We report a return to baseline weight after switching back to tenofovir disoproxil/emtricitabine/efavirenz (Atripla®) in a woman who had profound weight gain due to tenofovir alafenamide/emtricitabine/cobicistat/elvitegravir (Genvoya®).

Topics: Adult; Alanine; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Cobicistat; Drug Combinations; Emtricitabine; Female; HIV Infections; HIV-1; Humans; Quinolones; Tenofovir; Weight Gain

Topics: Adult; Alanine; Anti-HIV Agents; HIV Infections; Humans; Lipids; Obesity; Tenofovir; Weight Gain

Tenofovir-based antiretroviral therapy (ART) has become first-line in all major HIV treatment guidelines. Compared with tenofovir disoproxil fumarate (TDF), tenofovir alafenamide (TAF) has a favorable renal and bone safety profile, but concerns about metabolic complications remain.. To assess weight changes, the development of overweight/obesity, and changes in lipid levels 18 months after replacing TDF with TAF.. Cohort study.. 5 university hospitals, affiliated hospitals, and private physicians in Switzerland.. 4375 adults living with HIV who received TDF-containing ART for 6 months or longer.. Changes in weight and lipid levels were assessed using mixed-effect models. Differences in proportions of newly overweight/obese participants were calculated using 2-proportions. 4375 individuals were included, with follow-up between 1 January 2016 and 31 July 2019. Median age was 50 years (interquartile range, 43 to 56 years), 25.9% were female, and 51.7% had a normal body mass index (BMI); 3484 (79.6%) switched to TAF and 891 (20.4%) continued TDF. After 18 months, switching to TAF was associated with an adjusted mean weight increase of 1.7 kg (95% CI, 1.5 to 2.0 kg), compared with 0.7 kg (CI, 0.4 to 1.0 kg) with the continued use of TDF (between-group difference, 1.1 kg [CI, 0.7 to 1.4 kg]). Among individuals with a normal BMI, 13.8% who switched to TAF became overweight/obese, compared with 8.4% of those continuing TDF (difference, 5.4 percentage points [CI, 2.1 to 8.8 percentage points]). Switching to TAF led to increases in adjusted mean total cholesterol (0.25 mmol/L [9.5 mg/dL]), high-density lipoprotein cholesterol (0.05 mmol/L [1.9 mg/dL]), low-density lipoprotein cholesterol (0.12 mmol/L [4.7 mg/dL]), and triglyceride (0.18 mmol/L [16.1 mg/dL]) levels after 18 months.. Short follow-up, small subgroup analyses, and potential residual confounding.. Replacing TDF with TAF is associated with adverse metabolic changes, including weight increase, development of obesity, and worsening serum lipid levels.. Swiss National Science Foundation.

Topics: Adult; Alanine; Anti-HIV Agents; Blood Glucose; Cholesterol; Cholesterol, HDL; Cholesterol, LDL; Female; HIV Infections; Humans; Lipids; Male; Middle Aged; Obesity; Sensitivity and Specificity; Tenofovir; Triglycerides; Weight Gain

Although weight gain has been reported with the use of integrase strand transfer inhibitors (InSTI), concurrent use of tenofovir alafenamide (TAF) has been implicated in recent studies. This study examined weight changes in people living with HIV (PLWH) who switched from tenofovir disoproxil fumarate (TDF) to TAF, to clarify the relative contribution to weight gain of core agents versus TDF to TAF switch.. Antiretroviral-experienced, virologically suppressed PLWH in the U.S. OPERA cohort were included if they switched from TDF to TAF (5NOV2015-28FEB2019) and either maintained all other antiretrovirals or switched from a non-InSTI to an InSTI. Linear mixed models were used to assess weight changes before/after the switch to TAF (restricted cubic splines on time) and rates of change over time (linear splines on time, based on the shape of the weight change curves). Changes in weight on TDF or TAF were assessed among those who maintained other antiretrovirals (overall, by core class), and those who maintained an InSTI or switched to an InSTI (by core agent). All models were adjusted for age, sex, race, (age-sex, race-sex interactions), BMI, CD4 cell count, endocrine disorders and concurrent medications that could affect weight.. A total of 6908 PLWH were included, with 5479 maintaining all other antiretrovirals (boosted protease inhibitor: 746, non-nucleoside reverse transcriptase inhibitor: 1452, InSTI: 3281) and 1429 switching from a non-InSTI to an InSTI (elvitegravir/cobicistat: 1120, dolutegravir: 174, bictegravir: 129). In adjusted models, modest weight gain was observed over time on TDF for most (0.24 to 0.71 kg/year); raltegravir was the exception with weight loss. Switching to TAF was associated with early, pronounced weight gain for all (1.80 to 4.47 kg/year). This effect with TAF switch was observed both in PLWH maintaining other antiretrovirals and those switching to an InSTI, regardless of which InSTI agent was used. Weight gain tended to slow down or plateau approximately nine months after switch to TAF.. In this large, diverse U.S. cohort of PLWH, switching from TDF to TAF was associated with pronounced weight gain immediately after switch, regardless of the core class or core agent, suggesting an independent effect of TAF on weight gain.

Topics: Adult; Alanine; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Cohort Studies; Diabetes Mellitus, Type 2; Female; HIV Infections; Humans; Male; Middle Aged; Sustained Virologic Response; Tenofovir; Treatment Outcome; Weight Gain

Topics: Adolescent; Alanine; Anti-Retroviral Agents; Body Mass Index; Child; Cohort Studies; Female; Heterocyclic Compounds, 3-Ring; HIV Infections; Humans; Male; Oxazines; Piperazines; Pyridones; Retrospective Studies; Tenofovir; Weight Gain

Evaluate the impact of switching to an anti-retroviral regimen containing tenofovir alafenamide (TAF) on weight and the development of metabolic complications compared to remaining on a non-TAF containing regimen.Single-center retrospective case-control study.We evaluated people living with human immunodeficiency virus (PLWH) who were on an anti-retroviral regimen not containing TAF and were switched to a regimen containing TAF between January 1, 2016 and September 30, 2018. The control group included PLWH on a TAF free regimen throughout the study period. The primary outcome was change in weight from baseline to 12 months postswitch. Secondary outcomes included percent change in weight, change in body mass index (BMI), change in BMI class, and new diagnoses of diabetes, hypertension, and hyperlipidemia (HLD) during the study period.PLWH switched to TAF (n = 446) demonstrated significantly greater mean increase in weight compared to the control group (n = 162) (1.97 vs 0.88 kg, P = .01), however the effect was only seen in those switched from tenofovir disoproxil fumarate. Those that switched to TAF also had a significantly higher percent increase in weight, increase in BMI, and BMI class. We observed a higher rate of new diagnosis of HLD in the control group compared to the TAF switch group during the study period.PLWH switched to TAF had greater increases in weight after 1 year as compared to those continuing on a TAF free regimen. However, this did not translate to higher rates of obesity related illnesses such as diabetes, hypertension, and HLD during the follow up period.

Topics: Alanine; Anti-HIV Agents; Body Mass Index; Case-Control Studies; Comorbidity; Female; HIV Infections; Humans; Male; Middle Aged; Retrospective Studies; Tenofovir; Weight Gain

To evaluate the evolution of weight and lipid profiles before and after switch to co-formulated elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) among virally suppressed HIV-positive patients.. Patients switching to E/C/F/TAF between March and July 2018 were included. Weight, lipid profile (triglyceride (TG), total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C)), and glycated hemoglobin (HbA1c) levels at 48 weeks before and after the switch were analyzed using generalized estimating equations in order to identify the associated factors.. A total of 693 patients were included, and a weight gain was noted after the switch at weeks 12 (mean +0.63 kg), 24 (+1.25), 36 (+1.58), and 48 (+1.75) (all p < 0.0001). The weight change after the switch was significantly greater than that observed within the preceding 48-week period before the switch (+1.75 kg vs +0.54, p < 0.0001) and was correlated with switch to E/C/F/TAF (coefficient 0.29), later clinic visit (0.15), baseline weight (0.99), diabetes mellitus (coefficient -0.96), and age (-0.02) (all p < 0.01). At week 48, significant increases were observed for TG (mean +62.93 mg/dl), TC (+22.30), LDL-C (+9.70), HDL-C (+3.65) (all p < 0.01), and HbA1c (+0.08%) (p < 0.05), but not TC/HDL-C ratio (+0.12, p = 0.38).. Virally suppressed HIV-positive patients gained a moderate amount of weight and had significant increases in lipid levels after switching to E/C/F/TAF.

Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Cobicistat; Dyslipidemias; Emtricitabine; Female; HIV Seropositivity; Humans; Lipids; Male; Middle Aged; Quinolones; Retrospective Studies; Tenofovir; Weight Gain

To investigate whether the switch from tenofovir disoproxil fumarate/emtricitabine/rilpivirine (TDF/FTC/RPV) to tenofovir alafenamide (TAF)/FTC/RPV is associated with weight gain in people living with HIV (PLWHIV).. Retrospective single-centre study.. All PLWHIV on TDF/FTC/RPV who switched to TAF/FTC/RPV from January 2017 to December 2018 were considered if they had at least two weight measures in the year before and two after the switch. The weight trend across the study was evaluated by a generalized linear model for repeated measures, with pair comparison performed by Bonferroni adjustment.. Two hundred and fifty-two patients on TDF/FTC/RPV were included, 65% men, mean age 51.2 years (±9.6), history of 18 (±18.2) years of HIV infection and CD4 T-cell count of 744 (±329) cells/μl. All had HIV-RNA <50 copies/ml. Twelve months before the switch, baseline weight was 73.8 (±14.3) kg, and remained stable to 73.8 (±14.3) kg in the following 6 months. A weight increase was noticed 3 and 6 months after the switch, to 77.7 (±42.3) and 75.5 (±14.5) kg, respectively (P < 0.0001). A significant weight change exactly within the timeframe of the switch (between 6 months before and 3 months after) was found in women, patients with higher BMI (>25 kg/m), lower CD4 T-cell count (≤500 cells/μl) and history of previous drug abuse. The frequency of BMI greater than 25 kg/m rose from 122/252 patients (48.4%), to 133/252 (52.8%) (P < 0.0001).. TAF appears to have an impact on weight gain, similarly to what observed in naïve patients, also in experienced PLWHIV with good virologic control.

Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Emtricitabine; Female; Fumarates; HIV Infections; HIV-1; Humans; Male; Middle Aged; Retrospective Studies; Rilpivirine; RNA, Viral; Tenofovir; Treatment Outcome; Viral Load; Weight Gain

To determine whether changing from a tenofovir disoproxil fumarate (TDF)- to a tenofovir alafenamide fumarate (TAF)-containing regimen is correlated with weight changes in a human immunodeficiency virus (HIV)-positive adult cohort.. Retrospective analysis was conducted of data gathered from routine care in a university hospital in Munich, Germany, between July 2015 and June 2017. Data from patients' charts were extracted and a two-step approach was applied. First, weight/BMI progression within 1 year after initiation of either TDF or TAF was compared. Subsequently, weight measurements within subjects changing from a TDF- to a TAF-containing antiretroviral regimen were analyzed by means of a repeated measurements general linear model.. After 360 days of initiating TAF, patients showed a mean (± standard deviation) percentual weight increase of 3.17 ± 0.21, whereas after 360 days of initiating TDF, patients only showed a mean (± standard deviation) percentual weight increase of 0.55 ± 0.17. The repeated measurements general linear model for within-subjects design showed a statistically significant correlation in weight after changing from a TDF to a TAF containing antiretroviral regimen. The weight difference between the two measurements while on TDF was not statistically significant, but every measure after switching to TAF was significantly higher than the previous.. Changing from a TDF- to a TAF-containing regimen is correlated with weight gain in this retrospectively analyzed real-world cohort in Munich, Germany.

Topics: Adenine; Adult; Alanine; Anti-HIV Agents; Cohort Studies; Female; Fumarates; Germany; HIV Seropositivity; Hospitals, University; Humans; Male; Middle Aged; Retrospective Studies; Tenofovir; Weight Gain; Weight Loss