A Randomized Comparison of Second-Line Lopinavir/ Ritonavir Monotherapy versus Tenofovir/Lamivudine/ Lopinavir/Ritonavir in Patients Failing Nnrti Regimens: The HIV Star Study

Bunupuradah, Torsak; Chetchotisakd, Ploenchan; Ananworanich, Jintanat; Munsakul, Warangkana; Jirajariyavej, Supunnee; Kantipong, Pacharee; Prasithsirikul, Wisit; Sungkanuparph, Somnuek; Bowonwatanuwong, Chureeratana; Klinbuayaem, Virat; Kerr, Stephen J.; Sophonphan, Jiratchaya; Bhakeecheep, Sorakij; Hirschel, Bernard; Ruxrungtham, Kiat

doi:10.3851/imp2452

Cited by 17 publications

(33 citation statements)

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“…A recent Thai study randomized subjects failing first-line ART to either LPV/r monotherapy or LPV/r, FTC and TDF, and was conducted simultaneously with ACTG A5230 [25]. They observed that the proportion of subjects with viremia at levels 50–400 after 48 weeks was significantly higher in the monotherapy arm (14% versus 3%), leading them to conclude that 3-drug second-line regimens were superior.…”

Section: Discussionmentioning

confidence: 99%

Lopinavir/ritonavir monotherapy after virologic failure of first-line antiretroviral therapy in resource-limited settings

Bartlett

Ribaudo

Wallis

et al. 2012

Aids

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Objective To evaluate virologic response rates of lopinavir/ritonavir (LPV/r) monotherapy as second-line antiretroviral treatment (ART) among adults in resource-limited settings (RLS). Design Open-label pilot study of LPV/r monotherapy in participants on first-line non-nucleoside reverse transcriptase inhibitor 3-drug combination ART with plasma HIV-1 RNA 1000–200 000 copies/mL. Methods Participants were recruited from 5 sites in Africa and Asia within the AIDS Clinical Trials Group (ACTG) network. All participants received LPV/r 400/100mg twice daily. The primary endpoint was remaining on LPV/r monotherapy without virologic failure (VF) at week 24. Participants with virologic failure were offered addition of emtricitabine and tenofovir (FTC/TDF) to LPV/r. Results Mutations associated with drug resistance were encountered in nearly all individuals screened for the study. One hundred and twenty-three participants were enrolled, and 122 completed 24 weeks on study. A high proportion remained on LPV/r monotherapy without VF at 24 weeks (87%). Archived samples with HIV-1 RNA levels < 400 at week 24 (n = 102) underwent ultrasensitive assay. Of these subjects, 62 had levels < 40 copies/mL and 30 had levels 40–200. Fifteen subjects experienced VF, among whom 11 had resistance assessed, and 2 had emergent protease inhibitor mutations. The presence of baseline thymidine analogue mutations and K65R predicted a lower VF rate. Thirteen subjects with VF added FTC/TDF, and 1 subject added FTC/ TDF without VF. At study week 48, 11/14 adding FTC/TDF had HIV-1 RNA levels < 400 copies/mL. Conclusions In this pilot study conducted in diverse RLS, LPV/r monotherapy as second-line ART demonstrated promising activity.

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Section: Discussionmentioning

confidence: 99%

Lopinavir/ritonavir monotherapy after virologic failure of first-line antiretroviral therapy in resource-limited settings

Bartlett

Ribaudo

Wallis

et al. 2012

Aids

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“…In PI-naive adults failing an non-NRTI (NNRTI)-based first line regimen without TDF, 83% achieved virologic suppression after switching to TDF/lamivudine/ lopinavir/r. 43 In a study of heavily pretreated HIV-infected children, of whom 72% had ≥3 TAM with M41L mutation, adding TDF to the optimized background regimen (OBR) resulted in >1.0 log 10 copies/mL reduction of median HIV viral load among 15 of 18 children, with virologic suppression in 6 of 18 children by 48 weeks. 44 In a study of HIV-infected adolescents with pre-existing resistance mutations (49% of cases had ≥3 TAMs with either M41L or L210W) randomized to receive TDF or placebo with OBR, 41% of subjects overall achieved virologic suppression, but there was no difference between the TDF and placebo arms.…”

Section: Tdf As Part Of Second-line or Third-line Arv Regimensmentioning

confidence: 99%

Review of Tenofovir Use in HIV-infected Children

Aurpibul

Puthanakit

2015

Pediatric Infectious Disease Journal

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Tenofovir disoproxil fumarate (TDF) is approved by the Food and Drug Administration for use in children ages 2 years and older and is recommended by the World Health Organization for use as a preferred first-line nucleotide reverse transcriptase inhibitor in adults and adolescents ages 10 years and older. The simplicity of once daily dosing, few metabolic side effects and efficacy against hepatitis B virus make TDF suitable for use in a large scale program. Unlike thymidine analoge nucleoside reverse transcriptase inhibitors (NRTIs); tenofovir does not induce multi-NRTI resistance mutations, so more NRTI options are available for future second-line-regimens. Fixed-dose combinations of TDF with other ARVs as a single tablet regimen are now widely available for adults and adolescents, but none are available for young children. Current information on TDF including the pharmacokinetics, safety and tolerability in children and adolescents was reviewed. A dosing regimen according to body-weight-band has been established for pediatric use. Safety concerns of TDF mainly relate to its effects on renal function and bone mineral density. Regular monitoring of renal function in high-risk patients, including those on other nephrotoxic drugs, may be warranted to detect adverse renal effects. Long-term-data on renal and bone outcomes among HIV-infected children is needed. Lessons learned from clinical studies will help clinicians balance the risks and benefits of TDF and design appropriate antiretroviral regimens for children in different circumstances.

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“…[26][27][28] The other small 48-week comparative trial in Thailand showed that protease-inhibitor monotherapy was inferior to protease-inhibitor therapy plus NRTIs on the basis of lower rates of viral-load suppression to a level under 50 copies per milliliter (with only a trend toward lower rates of suppression to a level under 400 copies per milliliter and little protease-inhibitor resistance). 29 Since outcomes with protease-inhibitor monotherapy are better when treatment is initiated after viral-load suppression, 6,30,31 we used an induction approach with raltegravir. A longer induction period or a strategy including regular viral-load monitoring with immediate NRTI reintensification after viral-load rebound might have produced better outcomes, but such a regimen would be challenging to implement and would diminish the potential practical and cost advantages of protease-inhibitor monotherapy in resourcelimited settings.…”

Section: Discussionmentioning

confidence: 99%

Assessment of Second-Line Antiretroviral Regimens for HIV Therapy in Africa

Paton

Kityo

Hoppé³

et al. 2014

N Engl J Med

183

182

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A Randomized Comparison of Second-Line Lopinavir/ Ritonavir Monotherapy versus Tenofovir/Lamivudine/ Lopinavir/Ritonavir in Patients Failing Nnrti Regimens: The HIV Star Study

Abstract: The publisher would like to report an omission from a recently published article [1]. The title of Figure 3 should contain '(A)' and '(B)', and the correct title and corresponding figure are shown. The publisher apologizes for this omission.

Cited by 17 publications

References 1 publication

Lopinavir/ritonavir monotherapy after virologic failure of first-line antiretroviral therapy in resource-limited settings

Lopinavir/ritonavir monotherapy after virologic failure of first-line antiretroviral therapy in resource-limited settings

Review of Tenofovir Use in HIV-infected Children

Assessment of Second-Line Antiretroviral Regimens for HIV Therapy in Africa

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