IAS 2021: lenacapavir studies show impressive results in naive, extensive drug resistance and potential as PrEP

IAS 2021: HIV pipeline drugs: CAB/RPV LA, fostemsavir, paediatric dolutegravir, lenacapavir, islatravir, MK-8507 and albuvirtide

Lenacapavir submitted to FDA as long-acting treatment for MDR HIV

CROI 2021: First results using capsid inhibitor lenacapavir against MDR HIV: potential for six-monthly ART and PrEP

Gilead and Merck/MSD to collaborate on long-acting HIV combination of lenacapavir and islatravir

CROI 2021: Once-daily GSK254 maturation inhibitor as treatment for HIV multidrug resistance

CROI 2021: Dosing for once-weekly oral ART: islatravir plus MK-8507 studies due to start in 2021

US FDA approves long-acting injectable HIV treatment: monthly dosing

Long-acting injectable HIV treatment approved in the EU: includes two-monthly dosing

Fostemsavir approved in the EU (Rukobia): NICE deferred in the UK

EU approves dolutegravir 5 mg dispersible for children older than four weeks

New formulation of dolutegravir will make modern ART available for babies and young children at less than $120 a year

New neonatal liquid formulations of dolutegravir have comparable bioavailability to dispersible paediatric tablet

EMA issues positive opinion to approve cabotegravir LA/rilpivirine LA injections (Vocabria/Rekambys) as new HIV treatment

Capsid inhibitor lenacapavir, dosed six-monthly, has high barrier to drug resistance and no cross-resistance to other classes

Single doses of MK-8507 reduce viral load by mean –1.5 log and support once-weekly dosing above 80 mg

Capsid inhibitor lenacapavir (GS-6207) allows for 6-monthly dosing

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

EMA extends indication for darunavir/r to include adolescents >12 years

ViiV resubmits cabotegravir plus rilpivirine long-acting injections (Cabenuva, Vocabria) 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, Vocabria) 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

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