Gilead’s Truvada prevents HIV infections in high-risk men
pharmafile | September 10, 2015 | News story | Research and Development | Gilead, HIV, PrEP, Truvada, pre-exposure prophylaxis treatment, sexually transmitted infections
UK researchers say Truvada, Gilead’s HIV prevention treatment, should be added to the country’s ‘HIV prevention toolkit’, after a study found it lowers the risk of infection in gay men.
Using Truvada as a preventive treatment reduced the risk of HIV infection by 86% compared to waiting before taking treatment, the study found.
Previous trials have found that taking Truvada daily is an effective form of pre-exposure prophylaxis (PrEP) – a treatment taken by uninfected people to reduce the risk of infection. But there are concerns that this type of treatment could affect people’s sexual behaviour; encouraging people to increase risky sexual behaviour in the belief that the HIV medication is protecting them.
Truvada is licensed in the UK as a HIV treatment only, not as a PrEP therapy. To build the case for its use in HIV prevention in the UK, researchers conducted the PROUD study. It included 544 HIV negative gay men attending 13 sexual health clinics in England, who had had at least one episode of receptive or insertive anal intercourse without a condom in the previous 90 days. Men were randomly chosen to have PrEP treatment with Truvada either immediately or after a deferral period of one year, and then followed-up every three months and tested for HIV after 48 weeks.
During the study, a steering committee recommended all deferred participants be offered PrEP. At the end of the study there were three HIV infections in the immediate treatment group and 20 in the deferred group – an 86% relative reduction in risk of acquiring HIV compared with the deferred group. The 28 recorded adverse events that led to an interruption in PrEP included nausea and headache, but there were no serious adverse events related to the drug.
The rate of other sexually transmitted infections did not differ significantly between the two groups, although there was “a suggestion of risk compensation among a small proportion of PrEP recipients.”
The researchers highlight an economic assessment, based on a mathematical model adapted to the UK HIV epidemic in gay men, which suggests that providing targeted Truvada to at-risk gay men from 2016 would be cost-effective at its current price, or without targeted implementation if Truvada was half the price. Truvada costs around £4,000 a person a month and there are thought to be around 10,000 to 15,000 people in the high-risk category. UK surveys show that about 50% of gay men are interested in PrEP, but at least 25% are actively against the idea.
Writing in The Lancet the researchers, led by Professor Sheena McCormack from the Medical Research Council Clinical Trials Unit at University College London, conclude: “The impressive reduction in HIV incidence in people taking PrEP, without a measurable increase in other sexually transmitted infections, is reassuring for clinical, community, and public health stakeholders. National health services are under financial constraints, but they cannot afford to ignore the results, which strongly support the addition of PrEP to the current standard of prevention for men who have sex with men at risk of HIV infection.”
Lilian Anekwe
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