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



Lancet

Πρόσφατες δημοσιεύσεις στο περιοδικό The Lancet HIV

Bictegravir and dolutegravir: head to head at 96 weeks

In The Lancet HIV, David Wohl and colleagues1 present 96 week data on bictegravir in a fixed-dose combination with emtricitabine and tenofovir alafenamide versus fixed-dose dolutegravir, abacavir, and lamivudine for initial treatment of HIV, while Hans-JΓΌrgen Stellbrink and co-workers2 report 96 week data on co-formulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide for the same indication, both from randomised, double-blind, placebo-controlled, multicentre, phase 3 non-inferiority trials.

Is point-of-care early infant HIV diagnosis sustainable?

The high mortality of untreated HIV infection in infants was first documented in a study1 in 2004. However, the cumulative morbidity of late initiation of combination antiretroviral therapy (ART) is less well appreciated. For example, in a large cohort study2 from South Africa, almost 50% of children had advanced HIV disease when starting ART, at a median age of 43 months. The Children with HIV Early Antiretroviral (CHER) study3 provided the first evidence from a randomised controlled trial that initiating ART from a median age of 7Β·4 weeks was not only associated with significantly lower mortality, but also with less disease progression than when ART was deferred until a median age of 21 weeks.

Estimating fiscal space for health: pitfalls and solutions

In The Lancet HIV, Annie Haakenstad and colleagues1 report how much fiscal space for HIV/AIDS could be created in 137 low-income and middle-income countries. The research is timely and extremely important. Given substantial cuts in development assistance for HIV/AIDS,2 domestic financing is essential to sustain the response to the epidemic.

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