Αντιρετροϊκά Φάρμακα υπό δοκιμή

Ιούλιος 2014

Ως το 2024, η αντιρετροϊκή θεραπεία (ART) μπορεί να είναι τόσο διαφορετική από εκείνη που χρησιμοποιείται σήμερα ως τριπλή θεραπεία, όσο ήταν το 1997 όταν το ΑΖΤ ήταν το μόνο φάρμακο το 1987, ή όπως δραματικά εξελίχθηκαν τα σχήματα του ενός χαπιού μία φορά την ημέρα το 2014 σε σύγκριση με τις πολλαπλές δόσεις των κοκτέηλ του 1997. Πολλά μπορούν να γίνουν σε 10 χρόνια, αν και οι νέες εξελίξεις εν τέλει εξαρτώνται από φιλόδοξους στόχους και επαρκείς πόρους ώστε να μπορέσουν να καρποφορήσουν.

Ματιές στο μέλλον της ART προσφέρουν τα αντιρετροϊκά (ARV) που βρίσκονται φέτος υπό δοκιμή, όπως η άφιξη του συνδυαστικού χαπιού με το νέο αναστολέα ιντεγκράσης dolutegravir και το νέο NNRTI rilpivirine, η δυνατότητα λήψης δύο φαρμάκων μακράς δράσης που θα φέρει επανάσταση στη δοσολογία της θεραπείας και μια ήπια εκδοχή του tenofovir.

Compound

Class/Type

Comments

elvitegravir

INSTI

In November 2013, European Commission approved elvitegravir for use in combination with ritonavir-boosted PIs for individuals without evidence of resistance to elvitegravir

darunavir plus cobicistat
(co-formulation)

PI plus PK booster

EMA application filed October 2013; NDA filed April 2014

atazanavir plus cobicistat
(co-formulation)

PI plus PK booster

NDA filed April 2014

darunavir plus abacavir plus 3TC (co-formulation)

INSTI plus two NRTIs

U.S. and E.U. applications filed in October 2013

tenofovir alafenamide (TAF, GS-7340)

NtRTI (tenofovir prodrug)

In development as FDC component with elvitegravir, cobicistat, and FTC for treatment-naive and –experienced patients. Also as a component of FDC with darunavir, cobicistat, and emtricitabine. FDC with emtricitabine, as follow-up to Truvada, also in development

raltegravir (once-daily formulation)

INSTI

PK data from phase I once-daily formulation (2 x 600 mg tablets) studies presented at EACS 2013 and CROI 2014. A phase III study is expected to begin in 2014

dolutegravir plus
rilpivirine(co-formulation)

INSTI plus NNRTI

Clinical trials evaluating the safety and efficacy of the FDC as two-drug maintenance therapy are expected to begin in early 2015.

darunavir plus cobicistat plus FTC plus TAF
(co-formulation)

PI plus PK booster plus NtRTI and NRTI

Phase II study has been completed. A phase III study of the FDC has not yet been announced

apricitabine

NRTI

3TC-like molecule, stalled at phase IIb with no new studies listed since a phase III study was halted in 2009. A potential role for multiclass-resistant HIV. Partnership announced in December 2013 with NextPharma

BMS-663068

Attachment inhibitor (gp120)

Phase II data presented at CROI 2014

cenicriviroc
(TBR-652)

CCR5 inhibitor (also active against CCR2)

Phase II study results reported at EACS 2013. Tobira plans to study FDC of cenicriviroc plus 3TC in combination with third drug in phase III program

doravirine
(MK-1439)

NNRTI

Phase II data reported at CROI 2014

PRO 140

CCR5-specific humanized monoclonal antibody

No new data since 2010. Phase III trials, including treatment substitution protocol, are planned by CytoDyn

ibalizumab (TMB-355; formerly TNX-355)

CD4-specific humanized IgG4 monoclonal antibody

No data from treatment studies in several years; potential as long-acting preexposure prophylaxis

S/GSK1265744 oral and long-acting parenteral (LAP) formulations

INSTI (follow-up to dolutegravir)

Preliminary data supporting daily oral dosing as maintenance therapy, paired with oral rilpivirine, presented at CROI 2014. Demonstrates potential for once-monthly dosing with rilpivirine-LA

rilpivirine-LA (long-acting formulation)

NNRTI

Preliminary data supporting daily oral dosing as maintenance therapy, paired with oral S/GSK1265744, presented at CROI 2014. Demonstrates potential for once-monthly dosing with S/GSK1265755 LAP

OBP-601 (formerly BMS-986001)

NRTI

d4T-like molecule in phase II, with no new clinical data reported since 2012. Licensing agreement between Oncolys and BMS has been terminated and the compound returned to Oncolys for continued development

albuvirtide

Long-acting
fusion inhibitor

No new data or studies announced since 2013 Pipeline Report

CMX157

NtRTI (similar to TAF)

No new data or studies announced since 2013 Pipeline Report



Efficacy and Safety of Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) in Treatment-NaΓ―ve HIV-1 Infected Adults with Transmitted Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) Resistance Mutations

Fri, 16 Aug 2019 00:00:00 GMT-05:00 - Wong, Alexander; Goldstein, Deborah; Mallolas, Josep; DeJesus, Edwin; Johnson, Margaret; Molina, Jean-Michel; Pozniak, Anton; Rodgers, Anthony; Teal, Valerie; Hepler, Deborah; Kumar, Sushma; Sklar, Peter; Hanna, George J; Hwang, Carey; Badshah, Cyrus; Teppler, Hedy

Diagnostic accuracy of oral mucosal transudate tests compared to blood-based rapid tests for HIV among children ages 18 months to 18 years in Kenya and Zimbabwe

Fri, 16 Aug 2019 00:00:00 GMT-05:00 - Chikwari, Chido Dziva; Njuguna, Irene N.; Neary, Jillian; Rainer, Crissi; Chihota, Belinda; Slyker, Jennifer A.; Katz, David A.; Wamalwa, Dalton C.; Oyiengo, Laura; Bandason, Tsitsi; McHugh, Grace; Dauya, Ethel; Mujuru, Hilda; Stewart, Kearsley A; John-Stewart, Grace C.; Ferrand, Rashida A.; Wagner, Anjuli D.
Εισαγωγή: Gaps persist in HIV testing for children who were not tested in prevention of mother-to-child HIV transmission programs. Oral mucosal transudate rapid HIV tests (OMT) have been shown to be highly sensitive in adults but their performance has not been established in children.
Μέθοδοι: ART-naΓ―ve children aged 18 months to 18 years in Kenya and Zimbabwe were tested for HIV using rapid OraQuick ADVANCE Rapid HIV/2 Antibody test on oral fluids (OMT) and blood-based rapid diagnostic testing (BBT). BBT followed Kenyan and Zimbabwean national algorithms. Sensitivity and specificity were calculated using the national algorithms as the reference standard.
Αποτελέσματα: A total of 1,776 children were enrolled; median age was 7.3 years (IQR: 4.7, 11.6). Among 71 children positive by BBT, 71 were positive by OMT (sensitivity: 100% [97.5%CI: 94.9-100%]). Among the 1,705 children negative by BBT, 1,703 were negative by OMT (specificity: 99.9% [95%CI: 99.6-100.0%]). Due to discrepant BBT and OMT results, 2 children who initially tested BBT negative and OMT positive were subsequently confirmed positive within 1 week by further tests. Excluding these 2 children, the sensitivity and specificity of OMT compared to BBT were each 100% (97.5%CI: 94.9-100% and 99.8-100%, respectively).
Συμπεράσματα: Compared to national algorithms, OMT did not miss any HIV-positive children. These data suggest that OMTs are valid in this age range. Future research should explore the acceptability and uptake of OMT by caregivers and health workers to increase pediatric HIV testing coverage. Corresponding Author: Chido Dziva Chikwari Biomedical Research and Training Institute 10 Seagrave Road, Avondale Harare, Zimbabwe Tel: +263772773879/+2634745583 Email: Chido.DzivaChikwari@lshtm.ac.uk The authors report no conflicts of interest related to this work. * Joint first authors Funding: The study in Zimbabwe was jointly funded by the Duke Global Health Institute, the UK Medical Research Council (MRC) and the UK Department for International Development (DFID) under the MRC/DFID concordat agreement and is also part of the EDCTP2 programme supported by the European Union (MR/P011268/1). The Saliva Testing and Video Information to Expand Uptake of Pediatric HIV Testing (STEP-UP) study was funded by the National Institutes of Health (NIH; P30 AI027757 [CFAR New Investigator Award; PI: Wagner]) and the Thrasher Research Foundation (A119882). INN, DAK, JN, ADW were supported by P30 AI027757. ADW was also supported by A119882. INN was supported by Fogarty International Centre (FIC) D43TW009783. This publication was supported by the University of Washington Global Center for the Integrated Health of Women, Adolescents, and Children (Global WACh). This publication was funded in part by the University of Washington / Fred Hutch Center for AIDS Research, and NIH funded program under award number AI027757, which is supported by the following NIH Institutes and Centers: NIAID, NCI, NIMH, NIDA, NICHD, NHLBI, NIA, NIGMS, NIDDK. The content of this publication is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. This is an open access article distributed under the terms of the Creative Commons Attribution License 4.0 (CC BY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. - Β© 2019

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