Title: What ARV regimen to start in children 3 years old? (TDF)

Size: px

Start display at page:

Download "Title: What ARV regimen to start in children 3 years old? (TDF)"

Melina Blankenship
6 years ago
Views:

1 Title: What ARV regimen to start in children 3 years old? (TDF) Contents 1. PICO question Search strategy Flow diagram of screening process Evidence summaries Bibliography of included studies Excluded studies with reasons PICO question P I C O What ARV regimen to start (TDF in children) Infants and children living with HIV [include specific consideration of infants living with HIV whose mothers received TDF + 3TC(FTC) + EFV)] Use of TDF-containing regimens Use of non-tdf-containing regimens: AZT-based, ABC-based, D4T-based Mortality, morbidity, severe adverse effects, viral response, CD4 response, adherence, switching rate, care retention, tolerability, TB incidence 2. Search strategy Search Query #4 Search ((#1) AND #2) AND #3 #3 Search "TDF+3TC/FTC+EFV"[tiab] OR "TDF + FTC + EFV"[tiab] OR "TDF+FTC+EFV"[tiab] OR "TDF + 3TC + EFV"[tiab] OR "TDF+3TC+EFV"[tiab] OR (tenofovir[tiab] AND (lamivudine[tiab] OR emtricitabine[tiab]) AND efavirenz[tiab]) OR (TDF[tiab] AND (3TC[tiab] OR FTC[tiab]) AND EFV[tiab]) OR (TDF[tiab] AND FTC[tiab]) OR truvada[tiab] OR atripla[tiab] OR (epivir[tiab] AND emtriva[tiab] AND viread[tiab]) #2 Search "HIV Infections"[MeSH] OR HIV[MeSH] OR HIV[tiab] OR hiv-1*[tiab] OR hiv- 2*[tiab] OR hiv1[tiab] OR hiv2[tiab] OR HIV infect*[tiab] OR human immunodeficiency virus[tiab] OR human immunedeficiency virus[tiab] OR human immuno-deficiency virus[tiab] OR human immunedeficiency virus[tiab] OR ((human immun*) AND (deficiency virus[tiab])) OR acquired immunodeficiency syndrome[tiab] OR acquired immunedeficiency syndrome[tiab] OR acquired immuno-deficiency syndrome[tiab] OR acquired immunedeficiency syndrome[tiab] OR ((acquired immun*) AND (deficiency syndrome[tiab])) #1 Search randomized controlled trial [pt] OR controlled clinical trial [pt] OR randomized controlled trials [MeSH] OR random allocation [MeSH] OR double-blind method [MeSH] OR single-blind method [MeSH] OR clinical trial [pt] OR clinical trials [MeSH] OR ("clinical trial" [tiab]) OR ((singl* [tiab] OR doubl* [tiab] OR trebl* [tiab] OR tripl* [tiab]) AND (mask* [tiab] OR blind* [tiab])) OR (placebos [MeSH] OR placebo* [tiab] OR random* [tiab] OR research design [mh:noexp] OR follow-up studies [MeSH] OR prospective studies [MeSH] OR control*[tiab] OR prospectiv* [tiab]) OR non- 1

2 Search Query randomi*[tiab] OR before after study[tiab] OR time series[tiab] OR case control[tiab] OR prospective cohort[tiab] OR cohort*[tiab] OR cross-section*[tiab] OR prospective[tiab] OR retrospective[tiab] OR research design[mh:noexp] OR follow-up studies[mesh] OR prospective studies[mesh] OR control*[tiab] OR prospectiv*[tiab]) NOT (animals [MeSH] NOT human [MeSH]) 3. Flow diagram of screening process 638 records identified through database searching 273 duplicates removed 365 records screened 343 records excluded 22 full text articles assessed for eligibility 3 studies included in review 19 articles excluded after full text assessment 4. Evidence summaries Randomized controlled trials Switch to TDF + 3TC + EFV at baseline versus week 24 Outcome: morbidity (AIDS-defining events) (48 weeks) In one trial (Vigano 2005) with 48 weeks of follow-up, there was no significant difference in AIDSdefining events (none reported in either group) among participants switched to TDF + 3TC + EFV at Outcome: viral response (<50 copies/ml at 48 weeks) In one trial (Vigano 2005) with 48 weeks of follow-up, there was no significant difference in viral response (week 1: 14/14 versus week 24: 13/14) among participants switched to TDF + 3TC + EFV at 2

3 Outcome: study retention (48 weeks) In one trial (Vigano 2005) with 48 weeks of follow-up, there was no significant difference in on treatment completion (week 1: 14/14 versus week 24: 13/14) among participants switched to TDF + 3TC + EFV at Switch to TDF-based regimens versus maintained on AZT or d4t-based regimens among children 2 16 years old Outcome: immune response (VL <50 copies/ml) (48 weeks) In one trial (Gilead2 2012) with 48 weeks of follow-up, there was no significant difference in immune response with 71% in the TDF-based regimens versus 86% in the AZT or d4t-based regimens with VL <50 copies/ml. This quality of evidence was downgraded due to serious indirectness and serious Outcome: discontinuation (48 weeks) In one trial (Gilead2 2012) with 48 weeks of follow-up, there was no significant difference in discontinuations with 6.3% in the TDF-based regimens versus 4.1% in the AZT- or d4t-based regimens experiencing discontinuations. This quality of evidence was downgraded due to serious indirectness and very Outcome: Study retention (48 weeks) In one trial (Gilead2 2012) with 48 weeks of follow-up, there was no significant difference in study retention with 92% in the TDF-based regimens versus 98% in the AZT- or d4t-based regimens retained in the study. This quality of evidence was downgraded due to serious indirectness and very serious Switch to TDF-based regimens versus maintained on their current regimen among people years old Outcome: serious adverse event or death (48 weeks) In one trial (Gilead ) with 48 weeks of follow-up, there was no significant difference in serious adverse events or death, with 2.2% in the TDF-based regimens versus 0% in the current regimen arm experiencing one of these events. The quality of evidence was downgraded due to serious indirectness and very Outcome: viral response (48 weeks) In one trial (Gilead ) with 48 weeks of follow-up, there was no significant difference in viral response, with 70% in the TDF-based regimens versus 75% in the current regimen arm with viral response. This quality of evidence was downgraded due to serious indirectness and very serious Outcome: study retention (48 weeks) 3

4 In one trial (Gilead ) with 48 weeks of follow-up, there was no significant difference in study retention, with 59% in the TDF-based regimens versus 66% in the current regimen arm retained in the study. This quality of evidence was downgraded due to serious indirectness and very 5. Bibliography of included studies Initiation of ART in ART-naive children Randomized controlled trials: none identified. Observational studies: none identified. Initiation of ART in children switched to once-daily TDF regimens 1. Gilead2 study 2012 personal communication. 2. Gilead12 study 2012 personal communication. 3. Viganò A, Aldrovandi GM, Giacomet V, Merlo M, Martelli L, Beretta S, Luraschi P, Rombolà G, Mora S. Improvement in dyslipidaemia after switching stavudine to tenofovir and replacing protease inhibitors with efavirenz in HIV-infected children. Antivir Ther 2005;10: Excluded studies with reasons 1. Riordan A, Judd A, Boyd K, Cliff D, Doerholt K, Lyall H, Menson E, Butler K, Gibb D; Collaborative HIV Paediatric Study. Tenofovir use in human immunodeficiency virus-1-infected children in the United Kingdom and Ireland. Pediatr Infect Dis J 2009;28(7): Observational study, conducted in high-income countries, and included a mixture of ART-naïve and ART-experienced children without presenting data separately 2. Rosso R, Di Biagio A, Maggiolo F, Nulvesu L, Callegaro AP, Taramasso L, Bruzzone B, Viscoli C. Patient-reported outcomes and low-level residual HIV-RNA in adolescents perinatally infected with HIV-1 after switching to one-pill fixed-dose regimen. AIDS Care 2012;24(1):54-8. Single-arm study with no comparator. 3. Bergshoeff A, Burger D, Verweij C, Farrelly L, Flynn J, Le Prevost M, Walker S, Novelli V, Lyall H, Khoo S, Gibb D. Plasma pharmacokinetics of once- versus twice-daily lamivudine and abacavir: simplification of combination treatment in HIV-1-infected children (PENTA-13). Antiviral Ther 2005; 10: Single-arm study with no comparator. 4. Giacomet V, Bedogni G, Vigano A, Mora S, Manfredini V, Stucchi S, Erba P, Penagini F, Di Nello F, Brambilla P, Zuccotti GV. Six-year changes of anthropometric, total and appendicular fat masses measures in HIV-infected children switching from stavudine to tenofovir and from protease inhibitor to efavirenz. Infection 2011; 39:S Mora S, Zamproni I, Cafarelli L, Giacomet V, Erba P, Zuccotti G, Vigano A. Alterations in circulating osteoimmune factors may be responsible for high bone resorption rate in HIV-infected children and adolescents. AIDS 2007; 21:

5 6. Pontrelli G, Cotugno N, Amodio D, Zangari P, Tchidjou HK, Baldassari S, Palma P, Bernardi S. Renal function in HIV-infected children and adolescents treated with tenofovir disoproxil fumarate and protease inhibitors. BMC Infect Dis 2012; 12: Sam S, Ung V, Huot C, Chan B, Yuvatha K, Courpotin C, Adam G, Ngin S, Nerrienet E, Chhour YM. Lopinavir/ritonavir-based second line antiretroviral treatment in children at National Pediatric Hospital, Phnom Penh, Cambodia. Retrovirology 2009; 6(Suppl. 1):O25. Not relevant. 8. Vigano A, Bedogni G, Manfredini V, Giacomet V, Cerini C, di Nello F, Penagini F, Caprio C, Zuccotti GV. Long-term renal safety of tenofovir disoproxil fumarate in vertically HIV-infected children, adolescents and young adults: a 60-month follow-up study. Clin Drug Invest 2011; 31: Vigano A, Brambilla P, Cafarelli L, Giacomet V, Borgonovo S, Zamproni I, Zuccotti G, Mora S. Normalization of fat accrual in lipoatrophic, HIV-infected children switched from stavudine to tenofovir and from protease inhibitor to efavirenz. Antivir Ther 2007; 12: Vigano A, Brambilla P, Cafarelli L, Giacomet V, Borgonovo S, Zamproni I, Zuccotti G, Mora S. Normalization of fat accrual in lipoatrophic, HIV-infected children switched from stavudine to tenofovir and from protease inhibitor to efavirenz. Antivir Ther 2007; 12: Vigano A, Brambilla P, Pattarino G, Stucchi S, Fasan S, Raimondi C, Cerini C, Giacomet V, Zuccotti GV, Bedogni G. Long-term evaluation of glucose homeostasis in a cohort of HAARTtreated HIV-infected children: a longitudinal, observational cohort study. Clin Drug Invest 2009; 29: Vigano A, Zuccotti GV, Puzzovio M, Pivetti V, Zamproni I, Cerini C, Fabiano V, Giacomet V, Mora S. Tenofovir disoproxil fumarate and bone mineral density: a 60-month longitudinal study in a cohort of HIV-infected youths. Antivir Ther 2010; 15:

Short communication Tenofovir disoproxil fumarate and bone mineral density: a 60-month longitudinal study in a cohort of

Antiviral Therapy 2010 15:1053 1058 (doi: 10.3851/IMP1650) Short communication Tenofovir disoproxil fumarate and bone mineral density: a 60-month longitudinal study in a cohort of HIV-infected youths Alessandra