HTB

Antiretrovirals

US approval for darunavir (TMC-114, Prezista)

Boehringer stops tipranavir trial in treatment-naive patients

FDA approves fixed-dose combination of efavirenz/tenofovir/FTC (Atripla): joint company collaboration produces once-daily one pill combination

Evidence that CCR5 is protective against West Nile virus: implications for CCR5 inhibitors

Efavirenz levels above recommended upper target in 20% of African patients in Senegal

Lower dose of AZT provides adequate exposure in patients with low body weight

Fixed-dose formulation of efavirenz/tenofovir/FTC bioequivalent to separate dosing

Saquinavir/r (1000/100mg) levels reduced when taken fasted and should be taken with food

Lack of food effect with Meltrex formulation of lopinavir/r

Food interaction reduces ddI intracellular absorption and supports requirement to take fasted

Conflicting results on how T-20 affects tipranavir

Development of d-d4FC (dexelvucitabine, Reverset) discontinued

Other new antiretrovirals at Denver: the future seems bright

Early integrase inhibitor studies in treatment experienced patients raise hopes for new drugs in a new class

Atazanavir in treatment naive patients, with and without ritonavir boosting

CNS penetration of ARV drugs is associated with lower CSF viral load

Metrex formulation of Kaletra available on named patient access in UK

Treatment-naive trial of tipranavir discontinues highest dose arm

FTC studies at EACS: reduced incidence of M184V compared to 3TC; side effect profile in clinical practice

Efficacy of lopinavir/r in patients with advanced HIV (CD4 <25 cells/mm3)

Potential barriers to use of T-20: results from patient and physician interviews

Clinical experience of switching to atazanavir in the UK’s largest clinic

Replacing a PI with atazanavir: separating swans from ducklings?

TMC 125: some good and bad news

When to change a failing regimen: second-line and salvage strategies

Antiretrovirals and other stuff!

Understanding TMC114 power against resistant HIV

New antiretroviral compounds at ICAAC: new PI brecanavir from GSK; maturation inhibitor PA-457; antiviral activity of monoclonal antibody; TNX-355 in treatment experienced patients

Three measures confirm 144-week renal record of tenofovir

Low rash risk with efavirenz after nevirapine rash

SMART study halted due to safety concerns with significantly more AIDS events in the treatment interruption arm

TMC114 (darunavir) new drug applications submitted to US and European regulatory agencies

Named-patient access programme available in UK for new protease inhibitor darunavir (TMC114)

Tibotec discontinues TMC125 study C227: phase III studies continue

New Kaletra tablet formulation (meltrex) approved by FDA

GSK closes phase 3 studies of its CCR5 inhibitor aplaviroc and terminates development programme

Schering discontinues phase 2 studies of vicriviroc in treatment naive patients

FDA issues approvable letter for Bioject needle-free injection device

Improved clinical outcome in 80% patients who modified an NNRTI or PI dose following therapeutic drug monitoring (TDM)

GSK stops trials of CCR5 entry inhibitor GW873140 in naive patients

AZT comes off patent: generic versions approved for US market

Benefit of maintaining the M184V mutation with 3TC monotherapy: final 48-week results

Strategies for salvage therapy

Antiviral activity of foscarnet in salvage patients

Novel strategies with existing drugs

Antiretroviral activity of new and novel agents

FDA filing of T-20 sNDA for administration with a needle-free injection device

Reduced replicative capacity of M184V explains benefit of 3TC monotherapy compared to stopping all drugs

TMC-114 to be submitted for registration based on Phase 2b trial results: expanded access expected in UK in Autumn 2005

Tipranavir (Aptivus) approved in US

FDA fast track designation for CCR5 inhibitor vicriviroc (SCH-D)

Pfizer discontinues development of capravirine

Effect of age on lopinavir concentrations

Gender and pharmacokinetics of saquinavir

Responses to atazanavir, Kaletra and side effects

500mg saquinavir (Invirase) approved in Europe

Roche to withdraw saquinavir soft gel caps (Fortovase)

FDA approve lopinavir/r once daily for treatment naive patients

Safety data for tenofovir updated

FDA approve entecavir for HBV

Efavirenz warning in pregnancy strengthened

New ritonavir interactions

FDA advisory committee recommends approval for tipranavir – material from hearing online

Application for meltrex formulation of Kaletra submitted to the FDA

24-week efficacy of TMC114 in PI-experienced patients

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