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German medicines watchdog rejects ‘new tenofovir’ pill

The German health technology assessment agency IQWiG has announced that it finds no advantage in Descovy, a combination pill containing a new version of the HIV

Published
22 August 2016
By
Gus Cairns
Emtricitabine/tenofovir alafenamide in HIV infection: Added benefit not proven

When investigators reviewed Emtricitabine/tenofovir alafenamide in HIV infection, they found that partly no data were available, and partly the appropriate comparator therapy was not adhered to. The risk of nervous system disorders was increased for one patient group, they conclude.

Published
19 August 2016
From
German Institute for Quality and Efficiency in Health Care
German agency criticises European programme for speeding some drug approvals

In pointed remarks, Germany’s cost-effectiveness watchdog has criticised an effort by European regulators to accelerate approval for new medicines by limiting its requirements for evidence. The concerns raised by the agency come as regulators on both side of the Atlantic increasingly look to such approaches to get new drugs to patients with unmet medical needs. At issue is a proposal called adaptive pathways, a term used to describe a method for jumpstarting drug approvals for select patient populations. Two years ago,an EMA pilot programme was launched to compare initial data used for approval with so-called “real world” data, which is subsequently gathered after the medicines are in use.

Published
18 August 2016
From
STAT
ViiV Healthcare launches phase III programme evaluating a two-drug regimen combining dolutegravir and lamivudine for HIV-1 treatment

The phase III programme comprises two identical studies (GEMINI 1 and 2) comparing a two-drug regimen of dolutegravir plus lamivudine with a three-drug regimen of dolutegravir plus the fixed-dose tablet tenofovir/emtricitabine (Truvada®), as treatment for HIV-1 infection in adults who have not received prior antiretroviral therapy.

Published
16 August 2016
From
ViiV press release
Once-daily raltegravir works as well as twice-daily for initial HIV treatment

A new formulation of the integrase inhibitor raltegravir (Isentress) taken once daily suppressed HIV viral load as well as the older formulation taken twice a day in people

Published
26 July 2016
By
Liz Highleyman
Dolutegravir plus lamivudine dual therapy works well as initial HIV treatment

A two-drug regimen of dolutegravir and the well-tolerated NRTI lamivudine led to sustained viral suppression for most people starting antiretroviral therapy (ART) for the first time in a

Published
25 July 2016
By
Liz Highleyman
Long-acting injectable drugs work well for HIV maintenance therapy

Two long-acting injectable antiretrovirals – cabotegravir and rilpivirine – administered once every 4 or 8 weeks maintained viral suppression in people who switched regimens with undetectable viral load,

Published
22 July 2016
By
Liz Highleyman
HIV will only be cured with combinations too, conference delegates hear

Curing people of HIV infection will have to involve combinations of drugs and approaches, just as HIV treatment does, delegates heard at the Towards a Cure workshop

Published
20 July 2016
By
Gus Cairns
Treatment Action Group: Pipeline Report 2016

Drugs, Diagnostics, Vaccines, Preventive Technologies, Research Toward a Cure, and Immune-Based and Gene Therapies in Development.

Published
15 July 2016
From
Treatment Action Group
New integrase inhibitor bictegravir looks promising in early studies

Gilead Sciences' novel integrase inhibitor bictegravir (formerly GS-9883) demonstrated favourable pharmacokinetics, good tolerability, an improved resistance profile compared to older drugs in its class, and potent antiviral activity

Published
06 July 2016
By
Liz Highleyman
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Community Consensus Statement on Access to HIV Treatment and its Use for Prevention

Together, we can make it happen

We can end HIV soon if people have equal access to HIV drugs as treatment and as PrEP, and have free choice over whether to take them.

Launched today, the Community Consensus Statement is a basic set of principles aimed at making sure that happens.

The Community Consensus Statement is a joint initiative of AVAC, EATG, MSMGF, GNP+, HIV i-Base, the International HIV/AIDS Alliance, ITPC and NAM/aidsmap
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