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.






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

PI plus PK booster

EMA application filed October 2013; NDA filed April 2014

atazanavir plus cobicistat

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)


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


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

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



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


Attachment inhibitor (gp120)

Phase II data presented at CROI 2014


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



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)


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)


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


fusion inhibitor

No new data or studies announced since 2013 Pipeline Report


NtRTI (similar to TAF)

No new data or studies announced since 2013 Pipeline Report

Differences between groups of pre-exposure prophylaxis (PrEP) using couples in HIV-negative/unknown relationships

Thu, 11 Apr 2019 00:00:00 GMT-05:00 - John, Steven A.; Robles, Gabriel; Starks, Tyrel J.; Rendina, H. Jonathon
Εισαγωγή: Epidemiology research is limited on the characteristics of HIV pre-exposure prophylaxis (PrEP) using couples. Setting: United States nationwide sample recruited online in 2017.
Μέθοδοι: HIV-negative/unknown gay, bisexual, and other men who have sex with men (GBMSM) with HIV-negative/unknown partners (n=3140) were asked about individual and main partner PrEP uptake. Men were coded into five groups: 1) neither participant nor partner on PrEP, 2) partner only on PrEP, 3) participant only on PrEP, 4) both on PrEP, and 5) unknown partner PrEP use. We examined associations of demographics, relationship factors, condomless anal sex (CAS) with main and causal partners, bacterial sexually transmitted infection (BSTI) diagnoses, and sexual positioning with reported dyadic PrEP use using fully-adjusted multinomial logistic regressions.
Αποτελέσματα: PrEP use was 3.2% for the partner only, 5.7% for the participant only, and 4.9% for both participant and partner; 5.6% reported not knowing their partner’s PrEP use status. Men who reported any CAS with their main partner or any CAS with male casual partners were both more likely to be classified in the dyadic PrEP use group compared to the neither on PrEP group. Compared to monogamous, men in open arrangements were more likely to be classified in each of the three PrEP groups compared to the neither on PrEP group. Six-month BSTI prevalence was 2.8%, 8.1%, 8.3%, 15.6%, and 4.0% for the five groups, respectively.
Συμπεράσματα: PrEP use occurred during times of higher risk behavior engagement, but further efforts are needed to expand PrEP use to more partnered GBMSM. Author to whom correspondence should be addressed; Address: 695 Park Avenue, Room N611, New York, NY 10065; Phone: 212-206-7919; Fax: 212-206-7994; Email: hrendina@hunter.cuny.edu Conflicts of Interest and Source of Funding: Funding: Steven A. John was supported by the Center for AIDS Intervention Research (CAIR) and the National Institute of Mental Health (P30-MH052776, PI: Jeffrey A. Kelly). Gabriel Robles received support from the National Institute on Drug Abuse (R01-DA045613-01S1, PI: Tyrel J. Starks, Awardee: Gabriel Robles). H. Jonathon Rendina was supported in part by a career development award from the National Institute on Drug Abuse (K01-DA039060; PI: H. Jonathon Rendina). Data collection for this paper was supported in part by the Fordham HIV and Drug Abuse Prevention Research Ethics Training Institute (RETI), a training grant sponsored by the National Institute on Drug Abuse (R25-DA031608, PI: Celia B. Fisher). The authors also acknowledge the generous funding provided by the offices of the President, the Provost, and the Dean of Arts & Sciences of Hunter College, CUNY; additional support was also provided by Hunter College’s Center for HIV/AIDS Educational Studies & Training (CHEST). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health, Fordham RETI, Medical College of Wisconsin, or Hunter College, CUNY. Conflict of Interest: The authors declare that they have no conflict of interest. Previous meeting where part of these data were presented: International Association of Providers of AIDS Care (IAPAC) Conference, Miami, FL. June 8-10, 2018. - Β© 2019

Switching to Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) Maintains HIV-1 Virologic Suppression Through 48 Weeks: Results of the DRIVE-SHIFT Trial

Thu, 11 Apr 2019 00:00:00 GMT-05:00 - Johnson, Margaret; Kumar, Princy; Molina, Jean-Michel; Rizzardini, Giuliano; Cahn, Pedro; Bickel, Markus; Mallolas, Josep; Zhou, Yan; Morais, Cristiana; Kumar, Sushma; Sklar, Peter; Hanna, George J; Hwang, Carey; Greaves, Wayne; for the DRIVE-SHIFT Study Group
Εισαγωγή: Doravirine is a novel, non-nucleoside reverse transcriptase inhibitor (NNRTI) with demonstrated efficacy in treatment-naΓ―ve adults with HIV.
Μέθοδοι: In this open-label, active-controlled, non-inferiority trial, adults with HIV virologically suppressed for ≥6 months on 2 NRTIs plus a boosted protease inhibitor (PI), boosted elvitegravir, or an NNRTI were randomized (2:1) to switch to once-daily, single-tablet doravirine 100mg with lamivudine 300mg and tenofovir disoproxil fumarate 300mg (DOR/3TC/TDF) or to continue their current therapy (Baseline Regimen) for 24 weeks. The primary endpoint was the proportion of participants with HIV RNA <50 copies/mL (FDA Snapshot approach), with the primary comparison between DOR/3TC/TDF at week 48 and Baseline Regimen at week 24, and a secondary comparison between the groups at week 24 (non-inferiority margin, -8%).
Αποτελέσματα: 670 participants (447 DOR/3TC/TDF, 223 Baseline Regimen) were treated and included in the analyses. At week 24, 93.7% on DOR/3TC/TDF vs 94.6% on Baseline Regimen had HIV RNA <50 copies/mL (difference -0.9 [-4.7, 3.0]). At week 48, 90.8% on DOR/3TC/TDF had HIV RNA <50 copies/mL, demonstrating non-inferiority vs Baseline Regimen at week 24 (difference -3.8 [-7.9, 0.3]). In participants on ritonavir-boosted PI at entry, mean reductions in fasting LDL-C and non-HDL-C at week 24 were significantly greater for DOR/3TC/TDF vs Baseline Regimen (p<0.0001). Adverse events occurred in 68.9% on DOR/3TC/TDF and 52.5% on Baseline Regimen by week 24, leading to treatment discontinuation in 2.5% and 0.4%, respectively.
Συμπεράσματα: Switching to once-daily DOR/3TC/TDF is a generally well-tolerated option for maintaining viral suppression in patients considering a change in therapy. Registration: ClinicalTrials.gov NCT02397096 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. Corresponding Author: Wayne Greaves, MD, Merck Sharp & Dohme Corp., 126 E. Lincoln Avenue, RY34-A484, Rahway, NJ 07065-0900, (732) 594-3736, 305-7403, wayne.greaves@merck.com Conflicts of Interest and Source of Funding: Funding for this research was provided by Merck Sharp & Dohme Corp. (MSD), a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. MJ has received grants and consulting fees from Gilead and Viiv. PK is on Advisory Boards for ViiV, Janssen, Merck, and Theratechnologies; has received grants from Merck, ViiV, Gilead, and Theratechnologies; and owns stock in Johnson & Johnson, Gilead, Merck, Pfizer, and GSK. J-MM has received grants from Gilead and consulting fees (Advisory Board) from Gilead and MSD. GR has received Advisory board and speaker fees from JanssenCilag, Abbvie, Gilead Science, ViiV, MSD, and Angelini. PC is an Advisory Board member for MSD and ViiV and has received research grants from AbbVie, MSD, and ViiV. MB has no conflicts to declare. JM has received honoraria, speakers’ fees, consultant fees or funds for research from MSD, Roche, Boehringer-Ingelheim, ViiV, Gilead, Janssen, BMS, and Abbvie. YZ, CM, SK, PS, GJH, CH, and WG are current or former employees of MSD. Parts of the data were presented at: IDWeek 2018, San Francisco CA, 04-Oct-2018. - Β© 2019

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