Truvada Sales To Rise On EU Okay In HIV Prevention; UK Use Uncertain

The EU’s approval of Gilead’s Truvada for pre-exposure prophylaxis makes it the first medicine licensed in Europe to reduce the risk of HIV transmission through sexual intercourse and puts pressure on Britain’s reluctant, cash-strapped National Health Service to provide public funding for the drug’s preventative use.

EU approval of Gilead Sciences Inc.’s Truvada (emtricitabine and tenofovir disoproxil) for pre-exposure prophylaxis (PrEP) use to prevent HIV transmission should boost the therapy’s sales in the region - where 2.5 million people live with the condition - and help counter the recent rising trend in new HIV diagnoses, analysts say.

The European Commission granted marketing authorization for once-daily Truvada in combination with safer-sex practices to reduce the risk of sexually acquired HIV-1 infection among uninfected adults at high risk, a strategy known as pre-exposure prophylaxis, or PrEP.

PrEP EU Approval Four Years After US

Truvada is a combination of Gilead's HIV treatments Viread and Emtriva and has been available in the EU for the treatment of HIV infection since July 2005, but Gilead waited until early this year to seek the PrEP indication there, even though it was approved for prophylaxis in the US in 2012 and PrEP filings have been made in other countries including Australia and Canada.

It submitted a regulatory filing in January this year and won approval Aug 22. EU passage was largely expected after the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use issued a positive opinion in July this year. Until now, the drug’s EU market authorization was in combination with other antiretroviral agents for the treatment of adults with HIV-1 infection. It is the most prescribed antiretroviral drug in Europe as part of combination therapy.

The EU’s approval of Truvada for pre-exposure prophylaxis makes it the first drug licensed in Europe to reduce the risk of HIV transmission through sexual intercourse. Analysts say use of the therapy should help reduce HIV transmission rates across Europe, when used in combination with safer sex practices.

Truvada EU Sales Boost Foreseen

“People who use PrEP must commit to taking the drug every day and seeing their health care provider every three months. Data suggest that compliance and therefore efficacy will be higher in those over age 25. I think the commercial prospects of Truvada for PrEP in Europe are strong,” said Biomedtracker scientific analyst Zara Fulton.

I think the commercial prospects of Truvada for PrEP in Europe are strong.” - Biomedtracker Scientific Analyst Zara Fulton

In the first half of 2016, Truvada recorded sales of $1.8bn, up 13.6% on the same year-ago period. The rise was due mostly to bigger sales volume and reflected higher use of Truvada for PrEP. On its second-quarter 2016 results analysts call, Gilead drew attention to the growing use of Truvada for PrEP in the US.

The prevention of HIV transmission is a key to ending the AIDS epidemic. Prevention strategies focus on the most common routes of HIV transmission, utilizing a combination of increased education and awareness, behavioral change and treatment. In spite of a much greater knowledge about HIV and AIDS and existing prevention strategies, the overall incidence of HIV in Europe has not substantially decreased in the past decade. In men who have sex with men, the incidence has increased by more than 20% between 2005 and 2014. Around 30,000 people were newly diagnosed with HIV in 2014.

HIV is one of the primary areas of focus for Gilead. A spokesman for the US drug maker group said, “Gilead will now be working with the EMA to support educational initiatives with the medical community.” These include materials to ensure healthcare professionals understand the potential role of PrEP, in combination with safer sex practices, to reduce the risk of sexually acquired HIV-1 infection in adults at high risk, and tools to communicate with those to whom they may wish to prescribe Truvada for PrEP.

“We are now focused on working with national governments and payers to ensure Truvada for PrEP’s availability in countries across the EU.” – Gilead Spokesperson

“We are now focused on working with national governments and payers to ensure Truvada for PrEP’s availability in countries across the EU,” the Gilead spokesperson told Scrip.

Many patient interest groups have called for Truvada to be made available for PrEP in the EU. Calls for Truvada's use in HIV prevention have also been made by bodies like the World Health Organization and the European Centre for Disease Prevention and Control (ECDC).

France First PrEP Mover

France is the only European country where it’s available but demonstration projects are underway in a variety of European countries including Denmark, the Netherlands and Portugal. (Also see "France Leads Europe In Reimbursing Truvada For HIV Prophylaxis" - Scrip, 5 Jan, 2016.)

Although Truvada's use in HIV prevention had not yet been officially authorized in the UK or the rest of the EU it had been made available through a research trial called PROUD, which has now closed, and special programs, and it can also be accessed through various private schemes.

UK Reluctant PrEP Funder

But there is deepening controversy over NHS England’s funding for Truvada’s use for PrEP. Although Truvada has been shown to be highly effective in preventing transmission of the HIV virus in high-risk men, NHS England, which estimates the cost of funding PrEP at up to £20m per year, had argued that under the National Health Service Act 2006 it did not have the power to commission PrEP, and that this was a matter for the local authorities because it was a preventative public health measure. The local authorities disagreed, saying they did not have the money to pay for PrEP.

The decision was challenged in the High Court by the National Aids Trust, and after a hearing on July 13, Mr Justice Green ruled that in his judgment NHS England's powers included "commissioning for preventative purposes, and this includes for HIV-related drugs". NHS England is appealing the judgment. (Also see "Hepatitis C And PrEP Bring More Funding Headaches For NHS England" - Pink Sheet, 5 Aug, 2016.)

The UK HTA, NICE says that in the meantime it has been asked to conduct an evidence review of PrEP in high-risk groups, noting that as with any new intervention, PrEP must be properly assessed in relation to clinical and cost effectiveness. The evidence summary is due to be published this autumn.

Patient interest groups have condemned the stance being taken on the issue by NHS England and the Conservative government. Debbie Laycock, who heads policy and parliamentary affairs at the Terrence Higgins Trust said it was wrong that Truvada as use in PrEP is not currently available on the publicly-funded NHS.

“At the moment, people in the UK who want to take PrEP in order to protect themselves from HIV are having to buy generic versions of the drug online or pay a premium to purchase it on a private prescription. Currently, only those who can afford it are able to access this life-changing prevention treatment, further widening the inequality gap of those most affected by HIV,” she told Scrip.

“Meanwhile, people we know to be at very high risk of HIV who have been accessing PrEP as part of the PROUD trial, are already being exited from the trial and denied further access to free PrEP. Unless NHS England acts rapidly, we will continue to see a rise in new HIV infections in England,” Laycock said.

Commenting on the decision to take PrEP to an evidence review, Public Health Minister Jane Ellison said in a statement: “We know that PrEP can make a difference to both those at risk of contracting HIV, and those who are already HIV-positive. However, it is crucial that we have a full understanding of all the issues surrounding PrEP. That is why, as well as a pilot scheme, the government has called for an evidence review, which will help inform future commissioning decisions about PrEP.”