Efficacy and safety of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide in Asian participants with human immunodeficiency virus 1 infection: A sub-analysis of phase 3 clinical trials

Kim, So Hyun; Oka, Shinichi; Chetchotisakd, Ploenchan; Clarke, Amanda; Supparatpinyo, Khuanchai; Avihingsanon, Anchalee; Ratanasuwan, Winai; Kiertiburanakul, Sasisopin; Ruxrungtham, Kiat; Yang, SangYoun; Guo, Susan; Liu, Ya-Pei; Das, Moupali; Do, Tran; McColl, Damian J.; Corales, Roberto; Nguyen, Chris; Piontkowsky, David

doi:10.1080/15284336.2019.1589232

Cited by 8 publications

(7 citation statements)

References 13 publications

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“…Our study enrolled HIV/AIDS patients who underwent abdominal surgery. Of the HIV/AIDS patients on ART, most (32/35) achieved virologic suppression prior to surgery, which is roughly in line with other studies [23]. Thirty out of 64 patients did not choose ABT during the perioperative period, partly because ABT is not free in our health system.…”

Section: Discussionsupporting

confidence: 87%

Perioperative Antiretroviral Regimen for HIV/AIDS Patients Who Underwent Abdominal Surgery

Yang

Guo

et al. 2020

World j. surg.

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Background A short interruption of antiretroviral therapy (ART) and reduced oral bioavailability of antiretroviral medications could occur in perioperative human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS) patients who undergo abdominal surgery. Therefore, we focused on the changes in HIV viral load and CD4+ T lymphocyte count in HIV/AIDS patients after surgery and explored whether the perioperative use of intravenous antiretroviral drugs is beneficial in lowering the viral load and increasing the safety of the surgery. Methods We prospectively collected data from HIV/AIDS patients who underwent abdominal surgery at our institution from January 2019 and April 2019. According to the use of different antiretroviral medications during the perioperative period, the HIV/AIDS patients were divided into four groups: Group I: Patients continued their original antiretroviral medications; Group II: Patients received their original antiretroviral medications plus intravenous administration of the fusion inhibitor albuvirtide (ABT); Group III: Patients received ABT alone; and Group IV: Patients did not receive ART. The primary outcomes considered were the changes in HIV load and CD4+ T lymphocyte count and the postoperative complications in the four groups. Results A total of 64 HIV/AIDS patients were enrolled, and their data were analyzed descriptively. There were no differences between group I and group II in terms of the changes in viral load. The viral load continued to decrease in group III within 30 days after surgery, especially from D7 to D30 (t = 2.179, p = 0.043). However, the viral load showed an upward trend after surgery in group IV. There were statistically significant differences between the two groups in the changes in viral load after surgery (p = 0.022). However, there were no statistically significant differences between group III and group IV in the postoperative changes in the CD4+ T lymphocyte count. Seven out of 64 patients had postoperative infective complications. The incidence of complications from high to low was as follows: group IV > group I > group III > group II (p < 0.05). Conclusions A short perioperative interruption of ART may have a small impact on viral load in HIV/AIDS patients on virologic suppression after abdominal surgery. For patients with a detectable viral load, an intravenous injection of ABT in the perioperative period can reduce the viral load quickly, lower the occurrence of postoperative complications, and increase operation safety for both the HIV/AIDS patient and the surgeons.

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Section: Discussionsupporting

confidence: 87%

Perioperative Antiretroviral Regimen for HIV/AIDS Patients Who Underwent Abdominal Surgery

Yang

Guo

et al. 2020

World j. surg.

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“…Patients of Asian origin accounted for approximately 5-6% of the study population [11]. Considering such under-representation, data regarding the effectiveness of switching from TDF to TAF on reducing renal and bone toxicities in Asian patients with HIV infections remain scarce [12]. Further studies are needed to adequately inform HIV treatment in Asian populations.…”

Section: Introductionmentioning

confidence: 99%

Outcomes associated with treatment change from tenofovir disoproxil fumarate to tenofovir alafenamide in HIV‐1‐infected patients: a real‐world study in Japan

et al. 2021

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To investigate the impact of switching from tenofovir disoproxil fumarate (TDF)-to tenofovir alafenamide (TAF)-containing regimens on bone, kidney, serum lipids and body weight among Asian patients. MethodsA prospective, multicentre, observational cohort study was conducted at three centres for HIV infection in Japan during 2017-2019. HIV-infected adults previously treated with TDF-containing regimens and scheduled to switch to TAF-containing regimens were included. Bone mineral density (BMD), renal markers, lipids and weight were measured consecutively from 12 months before to 12 months after the switch. ResultsAmong 118 patients evaluated, the mean percentage change to spine BMD during 1 year of TAF treatment was higher than that during 1 year of TDF treatment (mean difference = 1.9%; 95% confidence interval (CI): 0.8-3.1). Urine protein and b 2 -microglobulin levels decreased significantly after the switch, while low-density lipoprotein cholesterol and triglycerides increased. During the TDF and TAF periods, the mean weight gains were 0.2 and 1.9 kg, respectively (mean difference = 1.6 kg; 95% CI: 0.9-2.3). Subgroup analysis revealed a significant difference between the mean body weight change associated with an integrase inhibitor (INSTI) (+2.8 kg) and that associated with a non-INSTI (+1.2 kg) third agent treatment only during the TAF period. ConclusionsAmong predominantly Japanese HIV-infected patients, BMD and renal tubular markers improved, while lipid profiles worsened significantly after the switch. Weight gain during the TAF period was larger than that during the TDF period. Concurrent use of INSTI with TAF may act synergistically to gain body weight.

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“…Furthermore, a recent pooled analysis of 26 trials showed the renal safety of TAF over TDF by examining a total of 12,519 person-years of exposure to TAF; there were no cases of proximal renal tubulopathy or Fanconi syndrome, and significantly fewer discontinuations due to renal adverse events in the TAF group than the TDF group (51). A sub-analysis of phase 3 clinical trials, which investigated efficacy and safety of elvitegravir/cobicistat/emcticitabine/TAF extracted the data of Asians and showed comparable efficacy and safety data between Asians and non-Asians (56). TAF is included as one of the components of the preferred ART regimens in the treatment guidelines in many high income countries (5,48,57,58).…”

Section: Tenofovir Alafenamidementioning

confidence: 99%

Tenofovir nephrotoxicity among Asians living with HIV: review of the literature

Nishijima

Gatanaga

Oka

2019

GHM

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Tenofovir disoproxil fumarate (TDF), prodrug of tenofovir (TFV), is one of the most widely used nucleotide reverse transcriptase inhibitors (NRTIs) for the treatment of HIV infection in resource-rich and resourcelimited settings with proven efficacy and safety, and also for the treatment of hepatitis B infections. However, TDF can cause renal proximal tubular dysfunction and also reduces estimated glomerular filtration rate (eGFR) more than other NRTIs. To date, TDF-associated renal dysfunction is generally regarded as mild and tolerable. However, it is notable that low body weight is one of the risk factors for TFV nephrotoxicity and that Asians are generally of smaller body stature and can be susceptible to such nephrotoxicity, as shown in several cohort studies. Until tenofovir alafenamide (TAF), another prodrug of TFV with minimal renal toxicity, becomes widely accessible for people living with HIV and replaces TDF, it is warranted that physicians who prescribe TDF have a good understanding of TFV nephrotoxicity. This paper reviews recent literature on TFV nephrotoxicity among people living with HIV especially focusing on Asians who might be susceptible to TFV nephrotoxicity due to their lower body weight and discusses implications for clinical care and future directions.

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Efficacy and safety of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide in Asian participants with human immunodeficiency virus 1 infection: A sub-analysis of phase 3 clinical trials

Cited by 8 publications

References 13 publications

Perioperative Antiretroviral Regimen for HIV/AIDS Patients Who Underwent Abdominal Surgery

Perioperative Antiretroviral Regimen for HIV/AIDS Patients Who Underwent Abdominal Surgery

Outcomes associated with treatment change from tenofovir disoproxil fumarate to tenofovir alafenamide in HIV‐1‐infected patients: a real‐world study in Japan

Tenofovir nephrotoxicity among Asians living with HIV: review of the literature

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