HTB

Antiretrovirals

FDA approve 600mg darunavir tablet

US study changes use of abacavir/3TC in naive patients with viral load >100,000 copies based on DSMB recommendation

Boehringer fails to register tipranavir in Brazil after using Brazilian patients in registrational study

Raltegravir approved in Europe and available in the UK

Paediatric lopinavir/r receives positive opinion from EMEA

Etravirine (TMC-125) approved in the US

Changes to atazanavir product label in US

HIV-positive adults with CD4 >500 cells/mm3 have similar mortality rates as the general population after seven years ARV treatment

Saquinavir/r non-inferior to Kaletra at week 48 (Gemini study)

Darunavir once-daily is non-inferior to lopinavir/r in treatment-naive patients at 48 weeks (Artemis study)

Half-dose Kaletra tablet approved for paediatric use in the US

Atripla approved in Europe as switch option for suppressed patients

Maraviroc approved in Europe for treatment-experienced CCR5-tropic patients

Paediatric formulation of fosamprenavir approved in Europe

Raltegravir approved in the US

EMEA recommends reinstating license for Roche’s nelfinavir

Roche withdraw application for Biojector needle-free option for T-20

Darunavir/r shows superiority over lopinavir/r at 48 weeks in TITAN trial

Maraviroc fails to show non-inferiority to efavirenz in treatment-naive patients: 48 week results

Importance of using maraviroc in combination with other active drugs in treatment-experienced patients

Week 48 raltegravir results in treatment-naive phase II dose-finding study

DUET studies clarify antiviral efficacy of etravirine and cross-resistance profile to other NNRTIs

Boosting atazanavir in treatment-naive patients, and impact on lipids after switching from lopinavir/r

Saquinavir/r vs lopinavir/r in treatment-naive patients

Fosamprenavir/r vs atazanvir/r in treatment-naive patients

Maraviroc approved in the US

Monogram launches Trofile HIV co-receptor tropism test

Raltegravir (MK-0518) phase 3 trials show successful viral suppression in multi-drug resistant patients

Maraviroc phase 2b/3 results in treatment experienced CCR5-tropic patients

Phase 2 study of Gilead’s integrase inhibitor elvitegravir (GS-9137)

Phase 2b study comparing rilpivirine (TMC-278) to efavirenz in treatment-naive patients: 48-week results

PK results from heat-stable formulation of ritonavir

Use of low-dose rapamycin, a CCR5 suppressant, to increase potency of T-20 in vitro

Darunavir (TMC-114) approved in Europe

No significant interaction reported between etravirine (TMC125) and raltegravir (MK-0518)

Future of second-generation fusion inhibitors less certain as Trimeris and Roche separate

Pharmacokinetic study of Triomune-40 in Malawi: higher d4T exposure suggests importance of using lower dose formulations of d4T

GSK stops development of brecanavir

FDA analysis of predicted responses to tipranavir/r

Important changes to US prescribing information for efavirenz

Changes to US product label for T-20 (enfuvirtide)

Explanation for failure of TMC-125 (etravirine) in TMC227 study

Saquinavir/r vs lopinavir/r: interim results from the Gemini study

TMC 114 recommended for conditional approval in Europe

Atazanavir 300mg capsule approved in US

Lipid profile of integrase inhibitor MK-0518: 24 week results compared to efavirenz in treatment naive patients

NRTI elvucitabine active against HIV in a 7-day monotherapy study

Efavirenz/tenofovir fails as 2-drug maintenance regimen

Early access programme for MK-0518 integrase inhibitor

Etravirine (TMC-125) available on named patient programme in the UK

Fixed dose combination (FDC) of tenofovir/FTC/efavirenz (Atripla) filed in EU

Tipranavir available in Scotland – almost one year after EU approval

FDA decision delayed on Biojector for administering T-20 pending additional safety information

Integrase inhibitor MK-0518: early results show greater early potency than efavirenz

Maraviroc results in R5/X4 mixed/dual tropic patients: unexpected safety data shows possible immunolocical effect

Vicriviroc 24-week results in triple-class experienced R5-tropic patients

Etravirine (TMC-125) associated with -1 log viral load reduction at 48-weeks results in treatment experienced patients

Three-class experienced patients experience 1 log viral load reduction using monoclonal antibody TNX-355

New data on darunavir (TMC-114)

Lopinavir/r monotherapy: less potent than triple therapy with higher risk of resistance

Atazanavir/r monotherapy and CNS penetration

Fosamprenavir/r is non-inferior to Kaletra in treatment naive patients

Tenofovir/FTC maintains greater virological response and reduced lipoatrophy compared to AZT/3TC after 96 weeks

Antiretroviral effect of foscarnet in patients with multiple drug resistance in late stage HIV disease

New formulation of lopinavir/r approved in Europe (Kaletra) and new tradename for access countries (Aluvia)

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