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



Knowledge of HIV status is associated with a decrease in the severity of depressive symptoms among female sex workers in Uganda and Zambia

Wed, 16 Oct 2019 00:00:00 GMT-05:00 - Ortblad, Katrina F.; Musoke, Daniel Kibuuka; Chanda, Michael M.; Ngabirano, Thomson; Velloza, Jennifer; Haberer, Jessica E.; McConnell, Margaret; Oldenburg, Catherine E.; BΓ€rnighausen, Till
Εισαγωγή: Knowledge of HIV-positive status may result in depressive symptoms, which may be a concern to scaling novel HIV testing interventions that move testing outside the health system and away from counselor support. Setting: Uganda and Zambia.
Μέθοδοι: We used longitudinal data from two female sex worker (FSW) cohorts in Uganda (n=960) and Zambia (n=965). Over four-months participants had ample opportunity to HIV test using standard-of-care services or self-tests. At baseline and four months, we measured participants’ perceived knowledge of HIV status, severity of depressive symptoms (continuous PHQ-9 scale, 0-27 points), and prevalence of likely depression (PHQ-9 scores β‰₯10). We estimated associations using individual fixed effects estimation.
Αποτελέσματα: Compared to unknown HIV status, knowledge of HIV-negative status was significantly associated with a decrease in depressive symptoms of 1.06 point in Uganda (95%CI -1.79, -0.34) and 1.68 points in Zambia (95%CI -2.70, -0.62). Knowledge of HIV-positive status was significantly associated with a decrease in depressive symptoms of 1.01 points in Uganda (95%CI -1.82, -0.20) and 1.98 points in Zambia (95%CI -3.09, -0.88). The prevalence of likely depression was not associated with knowledge of HIV status in Uganda, but was associated with a 14.1% decrease with knowledge of HIV-negative status (95%CI -22.1%, -6.0%) and 14.3% decrease with knowledge of HIV-positive status (95%CI -23.9%, -4.5%) in Zambia.
Συμπεράσματα: Knowledge of HIV status, be it positive or negative, was significantly associated with a decrease in depressive symptoms in two FSW populations. The expansion of HIV testing programs may have mental health benefits for FSWs. Contact details of the corresponding author: Katrina F. Ortblad, ScD, MPH International Clinical Research Center, University of Washington, Department of Global Health 908 Jefferson St, Seattle, WA 98104 katort@uw.edu; +1-206-265-1856 Conflicts of interest: The authors declare no conflicts of interest. Conferences: Ortblad K, Kibuuka Musoke D, Chanda M, Ngabirano T, Velloza J, McConnell M, Oldenburg C, BΓ€rnighausen T. Knowledge of HIV status decreases depressive symptoms among female sex workers. Conference on Retroviruses and Opportunistic Infections 2019. Seattle, WA. Sources of Support: International initiative for impact evaluation (3ie). This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. - Β© 2019

Reducing provider workload while preserving patient safety: a randomized control trial using 2-way texting for post-operative follow-up in Zimbabwe’s voluntary medical male circumcision program

Wed, 16 Oct 2019 00:00:00 GMT-05:00 - Feldacker, Caryl; Murenje, Vernon; Holeman, Isaac; Xaba, Sinokuthemba; Makunike-Chikwinya, Batsirai; Korir, Michael; Gundidza, Patricia Tapiwa; Holec, Marrianne; Barnhart, Scott; Tshimanga, Mufuta
Εισαγωγή: Voluntary medical male circumcisions (MC) is safe: the vast majority of men heal without complication. However, guidelines require multiple follow-up visits. In Zimbabwe, where high mobile phone ownership, severe healthcare worker shortages, and rapid MC scale up intersect, we tested a two-way texting (2wT) intervention to reduce provider workload while safeguarding patient safety. Setting: Two high-volume facilities providing MC near Harare, Zimbabwe.
Μέθοδοι: A prospective, un-blinded, non-inferiority, randomized control trial of 722 adult MC clients with cell phones randomized 1:1. 2wT clients (n=362) responded to a daily text with in-person follow-up only if desired or an AE suspected. The control group (n=359) received routine in-person visits. All men were asked to return on post-operative day 14 for review. Adverse events ≀ day 14 visit and number of in-person visits were compared between groups.
Αποτελέσματα: Cumulative AEs were identified in 0.84% (%% CI: 0.28,2.43) among routine care men as compared to 1.88% (95% CI: 0.86, 4.03) of 2wT participants. Non-inferiority cannot be ruled out (95% CI: -∞, +2.72); however, AE rates did not differ between groups (p=0.32). 2wT men attended an average of 0.30 visits as compared to 1.69 visits among routine care men, a significant reduction (p<0.001).
Συμπέρασμα: Although non-inferiority cannot be demonstrated, increased AEs in the 2wT arm likely reflect improved AE ascertainment. 2wT serves as a proxy for active surveillance, improving the quality of MC patient care. 2wT also reduced provider workload. 2wT provides an option for men to heal safely at home, returning to care when desired or if complications arise. 2wT should be further tested to enable widespread scale-up. Corresponding author: Caryl Feldacker, Box 359932, University of Washington, Seattle, WA 98104-3508 USA, cfeld@uw.edu Competing interests: The authors declare no competing interests Email addresses of all authors: Caryl Feldacker: cfeld@uw.edu Vernon Murenje: vmurenje@itech-zimbabwe.org Isaac Holeman: iholeman@uw.edu Sinokuthemba Xaba: xabasino@gmail.com Batsirai Makunike: bmakunike@itech-zimbabwe.org Michael Korir: korir@medicmobile.org Patricia Tapiwa Gundidza: ptgundidza@gmail.com Marrianne M Holec: mmholec@uw.edu Scott Barnhart: sbht@uw.edu Mufuta Tshimanga: tshimangamufuta@gmail.com Funding: Research reported in this publication was supported by the Fogarty International Center of the National Institutes of Health under Award Number R21TW010583. The content 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-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. - Β© 2019

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