Robert Fieldhouse
Rilpivirine gets green light in Wales
The All Wales Medicines Strategy Group (AWMSG) has recommended the NNRTI rilpivirine (EDURANT) for prescription on the NHS in Wales for people starting antiretroviral therapy. The AWMSG approval mirrors the recommendation for rilpivirine in the latest version of the BHIVA (British HIV Association) treatment guidelines. Clinical trials for rilpivirine have shown that it offers similar efficacy with fewer reported grade 2-4 adverse events (at least possibly related to treatment) compared to efavirenz. Taken as a 25mg once daily tablet, rilpivirine is now the smallest ARV tablet available. The tablet must be taken at the same time each day, with a meal, in combination with other antiretrovirals. Rilpivirine also forms part of Gilead’s Eviplera, a once daily fixed dose combination of rilpivirine and emtricitabine 200mg/tenofovir 300mg, also licensed in Wales. The latest Health Protection Agency (HPA) statistics show that HIV in Wales is growing at an unprecedented rate, with a 100 per cent increase of new diagnoses from 2002 to 2011 compared to only 12 per cent for the UK as a whole. However, advances in treatment and an emphasis on personalised regimens have meant that HIV-related deaths (including AIDS) have reduced in Wales by almost a third since 2007. The latest statistics show the impact of managing HIV effectively in Wales: the number of people accessing HIV care in Wales has increased by almost 245% (1,321) since 2001 (383) with the majority (1,077) on antiretroviral therapy. The number of HIV diagnoses in Wales is up to 2,034 due to a significant increase in HIV testing since 2004 (65,815). www.baseline-hiv.co.uk
Generic 3TC launched in the UK
Copycat versions of ViiV Healthcare’s 3TC (lamivudine) at 150mg and 300mg launched in the UK and Italy in June. This is the first generic HIV medicine to be made available by Mylan www.mylan.com in Europe. Mylan is one of the world’s leading providers of affordable antiretroviral drugs and is well-established distributing HIV medicines across the developing world. Lamivudine tablets had sales of approximately £2.6 million in the UK for the 12 months ending March 31, 2012.
Once daily maraviroc plus atazanavir looks good
A nucleoside/nucleotide analogue-sparing regimen (avoiding drugs like abacavir or tenofovir) but including the CCR5 antagonist maraviroc (Celsentri) plus the ritonavir-boosted protease inhibitor atazanavir (Reyataz) produced good viral control and was well tolerated over 96 weeks. The trial included 121 people starting HIV therapy, around 90% were men, three quarters were white, and the average CD4 cell count was approximately 350 cells/ mm3. Participants were randomised to receive either 50 mg once-daily maraviroc or coformulated tenofovir/ emtricitabine (Truvada), both with 200 mg atazanavir boosted with 100 mg ritonavir. At 96 weeks, 67.8% of people receiving maraviroc and 82.0% of those receiving tenofovir/emtricitabine had a viral load below 50 copies/mL). Three people taking maraviroc and two people taking tenofovir/emtricitabine experienced treatment failure. Average CD4 cell increases were similar in the two groups, at 264 vs 240 cells/mm3, respectively. People taking maraviroc showed a larger reduction in immune activation on CD4 cells at 48 weeks, consistent with earlier research suggesting maraviroc might reduce inflammation, but the clinical significance of this is unknown.
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