Low-dose versus standard-dose ritonavir-boosted atazanavir in virologically suppressed Thai adults with HIV (LASA): a randomised, open-label, non-inferiority trial

Bunupuradah, Torsak; Kiertiburanakul, Sasisopin; Avihingsanon, Anchalee; Chetchotisakd, Ploenchan; Techapornroong, Malee; Leerattanapetch, Niramon; Kantipong, Pacharee; Bowonwatanuwong, Chureeratana; Banchongkit, Sukit; Klinbuayaem, Virat; Mekviwattanawong, Sripetcharat; Nimitvilai, Sireethorn; Jirajariyavej, Supunnee; Prasithsirikul, Wisit; Munsakul, Warangkana; Bhakeecheep, Sorakij; Chaivooth, Suchada; Phanuphak, Praphan; Cooper, David A.; Apornpong, Tanakorn; Kerr, Stephen J.; Emery, Sean; Ruxrungtham, Kiat

doi:10.1016/s2352-3018(16)30010-8

Cited by 27 publications

(11 citation statements)

References 19 publications

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“…ART optimization through dose reduction of individual drugs can improve the efficacy and reduce the toxicity of ART regimens, lower their manufacturing costs, and help to achieve these goals [23,42]. It has been evaluated in several phase I-IV clinical trials with varying degrees of success [43][44][45]. The biggest success of dose reduction studies has been in the case of EFV.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of a single‐tablet regimen containing tenofovir disoproxil fumarate 300 mg, lamivudine 300 mg and efavirenz 400 mg as a switch strategy in virologically suppressed HIV‐1‐infected subjects on nonnucleoside reverse transcriptase inhibitor‐containing first‐line antiretroviral therapy in Pune, India

Dravid

Betha²,

Sharma³

et al. 2020

HIV Medicine

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Objectives As per National AIDS Control Organization (NACO) estimates, there are 2.1 million people living with HIV (PWH) in India, of whom 1.2 million are on first‐line antiretroviral therapy (ART). This study explored the use of a single‐tablet regimen containing tenofovir disoproxil fumarate 300 mg + lamivudine 300 mg + efavirenz 400 mg (TLE400 STR) as a first‐line switch strategy in PWH in Pune, India. Methods This retrospective cohort study was conducted in private sector ART clinics in three tertiary‐level hospitals in Pune, India. PWH > 12 years of age (n = 502) who initiated first‐line ART (predominantly TLE600 STR), completed ≥ 6 months of follow‐up and achieved virological suppression [plasma viral load (VL) < 1000 HIV‐1 RNA copies/mL] were identified and switched to TLE400 STR. The virological and immunological efficacy of TLE400 STR at 6 and 12 months of follow‐up were noted. Grade 3/4 adverse events (especially efavirenz‐related neuropsychiatric adverse events) leading to regimen discontinuation were also noted. Results Of 502 PWH who switched to TLE400 STR, complete virological suppression (VL < 20 copies/mL) was maintained in more than 97% of patients at follow‐up. TLE400 STR was successful in maintaining CD4 counts within the range observed at the start of the regimen. Grade 3/4 adverse events leading to TLE400 STR discontinuation were seen in 11 (2.2%) patients. Virological failure (VL > 1000 copies/mL) and treatment regimen failure were seen in six (1.2%) and 49 (9.8%) subjects, respectively. Conclusions TLE400 STR exhibits excellent efficacy and safety as a switch strategy and should be introduced in the Indian National ART Program, especially for PWH who are virologically suppressed on TLE600 STR.

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Section: Discussionmentioning

confidence: 99%

Efficacy and safety of a single‐tablet regimen containing tenofovir disoproxil fumarate 300 mg, lamivudine 300 mg and efavirenz 400 mg as a switch strategy in virologically suppressed HIV‐1‐infected subjects on nonnucleoside reverse transcriptase inhibitor‐containing first‐line antiretroviral therapy in Pune, India

Dravid

Betha²,

Sharma³

et al. 2020

HIV Medicine

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“…Decreasing ARV intake is not necessarily itself. Recent clinical trials have shown that certain selected ART regimens can be effective with a weekends-off schedule and entail less severe side effects [35], or that switching to a lower dose of Atazanavir was effective with less toxicity than the standard dose among Thai PLWHIV with mean bodyweight of 59 kg which is closer to women’s bodyweight [36]. In addition, it has been long advocated that health-related quality of life be considered in addition to efficacy when choosing between the many possible combinations of antiretroviral therapies [37].…”

Section: Discussionmentioning

confidence: 99%

How are women living with HIV in France coping with their perceived side effects of antiretroviral therapy? Results from the EVE study

Quatremère¹,

Guiguet

Girardi³

et al. 2017

PLoS ONE

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ObjectiveSide effects of antiretroviral therapy (ART) can have a negative impact on health-related quality of life threatening long-term retention in HIV care and adherence to ART. The aim of the French community-based survey EVE was to document personal experiences with side effects, the related physician-patient communication, and solutions found to deal with them.DesignCross-sectional study of women between September 2013 to September 2014MethodsAn anonymous online questionnaire included the HIV Symptom Distress Module, which explores 20 symptoms.ResultsIn all, 301 women on ART participated in the study (median age: 49 years; median duration of ART: 14 years). They reported having experienced a median of 12 symptoms (Q1-Q3: 9–15) during the previous 12 months. Overall, 56% of them reported having found at least a partial solution to dealing with their symptoms. Women reporting financial difficulties were twice less likely to have found solutions to coping with their side effects (AOR: 0.5; 95% CI: 0.3–0.8). Feeling supported by the health-care provider (AOR: 2.1; 95% CI: 1.1–3.9) and being in contact with HIV/AIDS organisations (AOR: 1.9; 95% CI: 1.2–3.2) were positively associated with coping. Seventeen percent reported having modified their ART regimen to improve tolerance, with only 2 in 3 informing their physician afterwards. Reporting financial difficulties and living with more bothersome symptoms increased the risk of ART regimen modification without health-care provider consultation.ConclusionThe EVE study has called attention to the large number of side effects experienced by WLWHIV, only half of whom have found self-care strategies to manage their symptoms. Modification of ART regimen by the women themselves was not uncommon.

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“…HIV-1-infected participants aged ≥18 years old with plasma HIV-1 RNA <50 copies/ml and currently using ATV, either 200 or 300 mg, with Norvir  SGC (Abbott Laboratories, North Chicago, IL, USA) 100 mg once daily plus two NRTI backbones were enrolled from HIV-NAT, The Thai Red Cross AIDS Research Centre, Bangkok, Thailand, and Chonburi Hospital, Chonburi, Thailand, into this prospective, open-label, 48-week single-arm study. Participants using ARV 200 mg were the participants who were previously enrolled in the low-dose versus standard-dose RTV-boosted ATV in virologically suppressed Thai adults with HIV (LASA) study conducted in HIV-NAT [5]. A subset of 16 participants using ATV 200 mg underwent intensive PK analysis.…”

Section: Methodsmentioning

confidence: 99%

“…Atazanavir (ATV) is preferred over lopinavir due to lower pill burden, better lipid profile and less gastrointestinal disturbance [3]. Boosted low-dose ATV of 200 mg showed adequate pharmacokinetic (PK) levels, great efficacy and safety for an HIV-1-infected Thai population [4][5][6][7]. The therapeutic level of ATV is between 0.15 and 0.85 mg/l [8].…”

mentioning

confidence: 99%

Pharmacokinetics and 48-week safety and efficacy of generic ritonavir tablet-boosted atazanavir in HIV-1-infected Thai adults

et al. 2017

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Background Ritonavir (RTV) tablets were not available in Thailand until they were manufactured by the Government Pharmaceutical Organization of Thailand. We assessed pharmacokinetics (PK), safety and efficacy of generic RTV-boosted atazanavir (ATV) in virologically suppressed HIV-1-infected Thai adults. Methods Virologically suppressed HIV-1-infected Thai adults who currently use ATV (either 200 or 300 mg) with Norvir® soft gel capsule (SGC) 100-mg-based regimen were enrolled into this prospective, 48-week single-arm study. Participants switched from Norvir® SGC to generic RTV. Plasma trough concentration (C) was assessed at trough baseline before switching to generic RTV and week 24 in all participants, with the target ATV C of 0.15 mg/l. trough Plasma HIV-1 RNA and other laboratory safety parameters were assessed until week 48. Results Of 100 participants (51% male) enrolled, 50% was using ATV 200 mg and 50% was using 300 mg at the time RTV SGC were changed into generic tablets. All participants used two nucleoside reverse transcriptase inhibitors (NRTIs) as backbone. There were no significant changes in mean (sd) Ctrough of RTV (0.20 [0.33] versus 0.23 [0.39]; P=0.21) and ATV (0.83 [0.93] versus 0.88 [0.95]; P=0.62) between baseline and week 24. From entry to week 48, median alanine aminotransferase significantly increased from 25 to 30 IU/l (P=0.001) and total bilirubin significantly decreased from 1.7 to 1.3 (P=0.04). One study drug related grade 3 adverse event was reported. All but one participant maintained plasma HIV-1 RNA <50 copies/ml after 48 weeks. Conclusions Generic RTV-boosted ATV showed adequate levels, good tolerability and great efficacy after 48 weeks.

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Low-dose versus standard-dose ritonavir-boosted atazanavir in virologically suppressed Thai adults with HIV (LASA): a randomised, open-label, non-inferiority trial

Cited by 27 publications

References 19 publications

How are women living with HIV in France coping with their perceived side effects of antiretroviral therapy? Results from the EVE study

Pharmacokinetics and 48-week safety and efficacy of generic ritonavir tablet-boosted atazanavir in HIV-1-infected Thai adults

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