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



Patterns and Predictors of HIV Status Disclosure in the 12 Months Following Diagnosis in Mozambique

Thu, 20 Feb 2020 00:00:00 GMT-06:00 - Taylor, Kate; Lamb, Matthew; Lahuerta, Maria; Ahoua, Laurence; Abacassamo, Fatima; Elul, Batya
Εισαγωγή: HIV disclosure benefits people living with HIV (PLWH), their partners, and HIV programs. However, data on the prevalence of disclosure and associated correlates have come largely from patients already in HIV care, potentially overestimating disclosure rates and precluding examination of the impact of disclosure on HIV care outcomes. Setting: We used data from an implementation study conducted in Maputo City and Inhambane Province, Mozambique. Adults were enrolled at HIV testing clinics following diagnosis and traced in the community 1 and 12 months later when they reported on disclosure and other outcomes.
Μέθοδοι: We examined patterns of participant disclosure to their social networks (N=1573) and sexual partners (N=1024) at both follow-up assessments, and used relative risk regression to identify correlates of non-disclosure.
Αποτελέσματα: Disclosure to one’s social network and sexual partners was reported by 77.8% and 57.7% of participants, respectively, at 1 month, and 92.9% and 72.4% of participants, respectively, at 12 months. At both time points, living in Inhambane Province, being single or not living with a partner, having high levels of anticipated stigma and not initiating HIV treatment were associated with increased risks of non-disclosure to social networks. Non-disclosure to sexual partners at both follow-up assessments was associated with being female, living in Inhambane Province and in a household without other PLWH, and reporting that post-test counselling addressed disclosure.
Συμπέρασμα: Although reported disclosure to social networks was high, disclosure to sexual partners was sub-optimal. Effective and acceptable approaches to support partner disclosure, particularly for women, are needed. Corresponding Author: Department of Epidemiology, Mailman School of Public Health, Columbia University, 722 W 168th St, Room 528, New York, NY, 10032. Email: be2124@columbia.edu Conflicts of Interest and Funding: The authors declare no conflicts of interest. The data used for this analysis was drawn from a study funded by the United States Agency for International Development (USAID), USAID Award Number: AID-OAA-A-12- 00027. The funder had no role in this analysis, decision to publish, or preparation of the manuscript. - Β© 2020

The Impact of a Structured, Supervised Exercise Program on Daily Step Count in Sedentary Older Adults With and Without HIV

Thu, 20 Feb 2020 00:00:00 GMT-06:00 - Stabell, Alex C.; Wilson, Melissa; Jankowski, Catherine M.; MaWhinney, Samantha; Erlandson, Kristine M.
Εισαγωγή: People with HIV (PWH) may have lower daily activity levels compared to persons without HIV. We sought to determine the impact of initiating a supervised exercise program on the daily step count of sedentary PWH and uninfected controls.
Μέθοδοι: PWH and controls, aged 50-75 were enrolled in a 24-week supervised exercise program. All individuals were given a pedometer and instructed in regular use. A linear mixed model taking into account random effects was used to model daily step count.
Αποτελέσματα: Of 69 participants that began the study, 55 completed and 38 (21 PWH, 17 controls) had complete pedometer data. Baseline daily step count on non-supervised exercise day was (estimated geometric mean, 95% CI) 3543 [1306, 9099] for PWH and 4182 [1632, 10187] for controls. Both groups increased daily steps on supervised (43% [20, 69]%, p<0.001) but not unsupervised exercise days (-12% [-24, 1]%, p=0.071). Compared with controls, PWH had 26% ([-47, 4]%, p=0.08) fewer daily steps on days with supervised exercise and 35% ([-53, -10]%, p=0.011) fewer daily steps on days without supervised exercise. Higher BMI (per 1 unit) and smoking were associated with fewer daily steps (-5% [-9, -1]%; -49% [-67, -23]%; p≤0.012). Days with precipitation (-8% [-13, -3]%, p=0.002) or below freezing (-10% [-15, - 4]%, p<0.001) were associated with fewer steps.
Συμπέρασμα: Supervised exercise increased daily step counts in sedentary individuals, but at the expense of fewer steps on non-supervised exercise days. Corresponding Author: Kristine M. Erlandson, 12700 E. 17th Avenue, Aurora, CO 80045, Kristine.erlandson@cuanschutz.edu, 303-724-4941; fax 303-724-4926 Conflicts of Interest: KME has served as a consultant for Gilead Sciences and ViIV Pharmaceuticals, and has a grant pending from Gilead Sciences. Funding: This work was supported by the Gilead Sciences Research Scholars Program in HIV (to KME) the National Institute of Aging of the National Institutes of Health [K23AG050260] to KME, and NCATS Colorado CTSA Grant Number UL1TR002535. The funding sources had no role in data collection, analysis, or interpretation; trial design; or patient recruitment. No payments were made in the writing of this manuscript. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. - Β© 2020

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