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

Tesamorelin, liver fat, and NAFLD in the setting of HIV

Management of abnormal liver function tests and cirrhosis, in the absence of hepatis B or C coinfection and high alcohol intake, has become an important issue in people with HIV on antiretroviral therapy (ART). One of the most common causes for abnormal liver function in both the general population and people living with HIV is non-alcoholic fatty liver disease (NAFLD), which has two forms: non-alcoholic steatohepatitis (NASH) or hepatic steatosis (figure). Between 6% and 35% of people globally1 have NASH-related cirrhosis, and it is the fastest growing indication for liver transplantation in the USA.

The global burden of HIV and prospects for control

HIV/AIDS continues to have devastating health effects globally, with over 39 million HIV/AIDS-related deaths to date and more than 36 million people living with HIV currently.1,2 Despite great advancements in antiretroviral therapy (ART) and worldwide progress towards implementation of treatment-as-prevention programmes, approximately 2 million people become newly infected with HIV every year.2,3 Retrospectively, evaluations of the HIV burden are integral to the assessment of control approaches.

Time to change cardiovascular prevention in people with HIV

Today, people with HIV live longer because of antiretroviral therapy (ART) but experience a higher risk of comorbidities, including atherosclerotic cardiovascular disease.1 Increased risk of cardiovascular disease might be due to not only classic risk factors, which are over-represented in the HIV-positive population, but also additional factors not present in the general population. These factors include chronic inflammation associated with HIV infection (even if successfully treated) and the use of some antiretroviral drugs, through mechanisms that are poorly understood.

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