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.
19 August 2016 | German Institute for Quality and Efficiency in Health Care
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.
18 August 2016 | STAT
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.
16 August 2016 | ViiV press release
Drugs, Diagnostics, Vaccines, Preventive Technologies, Research Toward a Cure, and Immune-Based and Gene Therapies in Development.
15 July 2016 | Treatment Action Group
“Depending on when you test positive for HIV, you could be looking at up to eight decades of treatment,” says Tim Horn of Treatment Action Group. “We need drugs that are gentler, kinder, better and cheaper.”
28 June 2016 | Poz
The European Commission has granted marketing authorization for Gilead Sciences' once-daily single tablet regimen (STR) Odefsey (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg or R/F/TAF) for the treatment of HIV-1 infection in certain patients.
27 June 2016 | PharmaBiz
A new integrase inhibitor known as bictegravir (BIC, GS-9883) was found to be well tolerated and effective as HIV treatment in a 10-day monotherapy study, warranting further investigation of the drug, according to research presented at ASM Microbe 2016 in Boston, Massachusetts.
21 June 2016 | The Body
Frontier Biotechnologies Inc. today reported that a phase 3 clinical trial (TALENT Study) of its lead product albuvirtide meets primary objective based on an interim analysis. The results demonstrated that once-weekly given albuvirtide plus ritonavir-boosted lopinavir was non-inferior to WHO-recommended second-line three-drug regimen (control) at 48-week in treatment experienced HIV-1 infected adults. In addition, patients administered with albuvirtide showed statistically better renal safety than those taking the control regimen containing tenofovir disoproxil fumarate.
07 June 2016 | Frontier Biotech press release
ViiV Healthcare, which is majority-owned by GSK, said on Friday it was the first time that Tivicay, or dolutegravir, was being made available as a first-line treatment as part of a national health program in sub-Saharan Africa.
03 June 2016 | Reuters
Gilead Sciences, Inc. today announced that the European Commission has granted marketing authorization for two doses of Descovy® (emtricitabine and tenofovir alafenamide 200/10 mg and 200/25 mg; F/TAF), a fixed-dose combination for the treatment of HIV-1 infection. Descovy is Gilead’s second TAF-based therapy to receive marketing authorization in the European Union.
25 April 2016 | Gilead press release