The first proven drug for prevention of HIV infection has been recommended for FDA approval by an expert panel.

Truvada from Gilead Sciences, an oral combination therapy used since 2004 to treat HIV infection, may shortly be available as a preventative therapy.

The panel emphasised that the drug is less effective in women than in men, and must not be used in place of other preventative strategies.

Adherence was also highlighted as an issue, since Truvada is ineffective if not taken every day.

Truvada was recommended for prescription to people at high risk of HIV infection, including gay and bisexual men and heterosexual couples with one HIV-positive partner.

The medication is a combination of two anti-HIV drugs, Emtriva and Viread. Its off-label use to prevent HIV infection is already widespread.

In 2010, a three-year study by the US government found that daily doses of Trevada together with condom use reduced the risk of HIV infection by 42% in gay and bisexual men. In 2011, a similar study found that it reduced infection by 75% in heterosexual couples where one partner was HIV-positive.

The drug’s value is contested among people working to control HIV infection, due to concerns that Trevada will give people who are not compliant with the need for condom use and/or daily dosage a false sense of security.

While the cost of widespread prescription is not a factor in whether the FDA grants marketing approval for Trevada, it will clearly affect its uptake by health workers relative to other strategies.

The Marketing Authorisation Application for Gilead Sciences Quad single-tablet regimen for the treatment of HIV-1 has been validated by the EMA.

The application is supported by results from two Phase III studies which demonstrated the tablet’s safety and efficacy data and by clinical data for the individual components of the Quad and Chemistry, Manufacturing and Controls (CMC) information.

Norbert Bischofberger, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences, says Gilead is working with the regulator “to bring this new single-tablet regimen to physicians and patients as quickly as possible”.

The regimen contains elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate and was submitted to the EMA in November 2011. The submission to the FDA was made in October 2011.

Gilead’s first single-table regimen, Atripla, was approved in the EU in 2007. Its second single-tablet regimen, Eviplera – which combines its Truvada and Tibotec Pharmaceutical’s rilpivirine – was approved in the EU in November 2011.

“Based on the safety and efficacy data from the Phase 3 pivotal studies, we believe the Quad single-tablet regimen has the potential to be a convenient treatment option for patients new to HIV therapy,” said Norbert Bischofberger.

A new once-daily single tablet for initial treatment of HIV infection, making combination drug therapy simpler, has been approved for marketing in the EU.

Eviplera, supplied by Gilead Sciences in collaboration with Tibotec Pharmaceuticals, has been approved by the European Commission as a first antiretroviral in adults whose viral load is below 100,000 HIV-1 RNA copies/ml.

The new drug combines Gilead’s Truvada, a fixed-dose combination of the reverse transcriptase inhibitors emtricitabine and tenofovir disoproxil, with Tibotec’s rilpivirine (sold by Janssen-Cilag as Edurant).

“As people with HIV are living and remaining on treatment longer, the availability of new simplified therapeutic options has become even more critical,” said Dr. Mark Nelson, Service Director for the HIV Directorate, Chelsea and Westminster Hospital, London, United Kingdom.

"Eviplera has the potential to be an important new treatment option for patients starting HIV therapy because it streamlines an effective HIV treatment regimen into a single daily tablet.”

John C. Martin, Chairman and CEO of Gilead Sciences, commented: "Gilead continues to lead the development of single-tablet regimens because we and our partners recognize the ongoing need to simplify HIV therapy. With Eviplera, we are now working with national authorities to ensure the regimen is made available across the EU as quickly as possible.”

Eviplera is the second single-tablet HIV treatment to gain marketing approval in the EU. The first, Atripla, was launched in in 2007 by Gilead in partnership with Bristol-Myers Squibb and MSD.

The authorisation of Eviplera was supported by phase III clinical trials carried out by Tibotec that demonstrated the efficacy and safety of rilpivirine in treatment-naïve HIV-infected adults, and a bioequivalence study carried out by Gilead which showed the single tablet to achieve the same levels of medication in the blood as the three drugs administered separately.

Gilead will lead the manufacturing and commercialisation of Eviplera in the EU, the US, Canada, Brazil, Australia and New Zealand, while Tibotec will be responsible for commercialising rilpivirine as a single agent and can co-detail the single-tablet regimen in these territories.

Tibotec will commercialise the product in Africa, the Middle East, Eastern Europe and Japan.

The FDA has approved a once-per-day combined pill by Gilead and Johnson & Johnson for the treatment of HIV in the US.

Complera has been approved as a first-line treatment for patients who have not been previously treated for HIV.

The pill combines Gilead’s drug Truvada (emtracitabine and tenofovir) and Johnson & Johnson’s Edurant (rilpivirine).

Both drugs are already approved as part of a drug cocktail or combination HIV therapy, but the combined pill is now approved as a stand-alone regimen.

Further manufacturing, development and marketing are set to be headed by Gilead in the EU, Canada, Brazil, Australia and New Zealand.

Complera is the second once-per-day drug intended for untreated HIV, approved in 2006. The first was Atripla, which is marketed by Gilead and Bristol-Myers Squibb.