HTB

Antiretrovirals

US FDA approves dolutegravir/lamivudine (Dovato) as switch option

ViiV resubmits cabotegravir plus rilpivirine long-acting injections (Cabenuva) to FDA for approval

ADVANCE 96-week results: dolutegravir weight gain continues, especially in women and when used with TAF – no evidence of a plateau

FDA approves fostemsavir (Rukobia) for multidrug resistant HIV in the US

FDA approves dolutegravir formulations to treat infants and young children

Fit for purpose: antiretroviral treatment optimisation March 2020

Long-acting cabotegravir and rilpivirine injections support two-monthly dosing

Safety and PK of bNAb elipovimab (GS-9722) support two-weekly dosing

First results with long-acting capsid inhibitor GS-6207: oral and subcutaneous formulations for use in naïve and multidrug resistance

Long-acting cabotegravir and rilpivirine: similar results in women and men 

FDA decision on long-acting cabotegravir/rilpivirine (Cabenuva) injections delayed due to scale-up manufacturing problems

Fostemsavir submitted to EMA for treating multidrug resistant HIV

Gilead announces licensing agreement for Rockefeller University bNAbs

Capsid inhibitor GS-6207 (lenacapavir): potential for 6 monthly dosing for MDR HIV

Dolutegravir/lamivudine as dual ART

Weight changes with doravirine-based first line therapy

Doravirine approved by NHS England as single NNRTI and as part of FDC with 3TC/TDF

Fostemsavir submitted to US FDA for multidrug resistant HIV

Paediatric dispersible formulation of dolutegravir submitted to EMA and FDA

Ibalizumab approved in the EU

HIV suppression and safety with ibalizumab at 48 weeks in expanded access

Oral cabotegravir and rilpivirine is durable for 5.5 years in LATTE study

Dolutegravir plus rilpivirine had good virologic, safety record in clinics before single tablet available

Switching from TDF to TAF linked to higher BMI and cardio risk

Possible higher diabetes risk with raltegravir or PIs than NNRTIs

Dual dolutegravir/lamivudine submitted to US FDA as switch option

Scotland approves dual therapy with dolutegravir/lamivudine (Dovato)

FDA expands indication for doravirine in the US as switch option

Switching to bictegravir/F/TAF in virally suppressed participants – including analyses by baseline drug resistance

Dolutegravir-based first-line non-inferior to efavirenz-based ART but associated with substantial weight gain: results from the ADVANCE study

Cabotegravir/rilpivirine long-acting injectable HIV drugs submitted to EMA

First viral load results for capsid inhibitor GS-6207: mean –2.2 log reduction at day 10

Islatravir (MK-8591) with doravirine plus lamivudine: 24 week results

Dual therapy with islatravir (MK-8591) plus doravirine: 24 week results as switch strategy

Fostemsavir: 96-week follow-up in people with multi-drug resistance

Dolutegravir/lamivudine dual therapy non-inferior to triple ART at week-96

Switching to dolutegravir/lamivudine dual therapy is non-inferior to TAF-based triple therapy at week-48 in TANGO study

IAS 2019: late breaker highlights to look for

HIV pipeline report 2019

Dolutegravir/lamivudine approved as dual HIV combination in EU

Dual long-acting cabotegravir/rilpivirine injection submitted to FDA

Dolutegravir/3TC dual FDC (Dovato) approved in the US and given positive opinion in the EU

Maturation inhibitor GSK’232 reduces viral load by –1.5 log at day 10

Capsid inhibitor GS-6207 shows potential for 3-monthly injections

First phase 1 results from bNAb PGT121 in HIV positive people

Dolutegravir/3TC dual ART is as effective at lowest viral load cut-off as triple therapy in GEMINI studies

Same-day ART is effective in San Francisco Rapid-ART clinic

Phase 3 results with dual therapy cabotegravir/rilpivirine long-acting injections: ATLAS and FLAIR studies

FDA approves generic TDF/3TC for use in the US

Doravirine (Pifeltro) and doravirine/TDF/3TC FDC (Delstrigo) approved in Europe

Viral dynamics of dolutegravir-based dual versus triple ART

Ibalizumab: 48-week phase 3 results in 27 participants with MDR HIV

Fostemsavir: 48-week phase 3 results from BRIGHTE study

Dolutegravir non-inferior to low dose efavirenz in real-life African study conducted in Cameroon  

Dual bNAb maintains viral suppression for median 21 weeks off-ART

Cabotegravir levels can be detected several years: PK tail to be covered by oral PrEP

FDA updates rilpivirine label for use during pregnancy

Dolutegravir/lamividune FDC submitted to EMA and FDA

English court finds in favour of access to generic TDF/FTC

FDA approves doravirine (Pifeltro) and new FDC with TDF/3TC (Delstrigo) in the US

FDA update labels for dolutegravir and dolutegravir-based FDCs to reflect potential risk of neural tube defects

Top-line phase 3 results released for cabotegravir/rilpivirine long-acting injections

Interactions between oral anticoagulants and Genvoya, Stribild and cobicistat: FDA label updates

DTG/3TC dual therapy is non-inferior to triple-ART in GEMINI study

Superior efficacy with dolutegravir-based ART compared with other regimens at 6 months: real-world data from Brazil 

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