Presentation in Spain of a new antiretroviral therapy to treat HIV-1.

Intelence ® (Etravirina) is the first reverse transcriptase inhibitor non-nucleoside analogue introduced in Europe in nearly 10 years

• The profile of a patient who would benefit from this new therapy is one that does not respond to current treatments

• Nearly 80% of patients treated with etravirina, in joint administration with other active drugs achieved undetectable viral load

• In Spain more than 700 patients have received compassionate use etravirina by or through an Expanded Access Program

Last January 30 was made in Spain INTELENCE ® (etravirina), a new therapeutic alternative for adults infected with HIV type 1 (HIV-1) that have been previously treated with other antiretrovirals, which have generated resistance to treatment.

INTELENCE ® (etravirina) belongs to a new generation of antiretroviral drugs that, taken together with a boosted protease inhibitor and other antiretroviral drugs, reduces the amount of HIV in the blood and keeps it low. Its aim is to curb the deterioration of the immune system, the emergence of infections and diseases associated with AIDS in those who have shown resistance to other therapies.

For Enrique Ortega, head of the Infectious Disease Unit of the Hospital General Universitario de Valencia, this new drug has an advantage because capital "is able to deal with him to a high percentage of people infected with HIV that showed resistance and in which treatments were no longer effective. " According to Jose Maria Gatell, head of Service of Infectious Diseases and AIDS of Hospital Clinic of Barcelona, "etravirina be used as a component of the combinations of rescue in adults who have failed one or more previous treatments, and generally with multiple resistance mutations andalusia virus. But due to its good tolerance may, in some situations, replacing the current ITNN (nevirapine or efavirenz) in earlier stages of infection. "

The indication of INTELENCE ® (etravirina) is based on the analysis performed at week 24, two studies DUET 1 and DUET 2 in 1203 adults infected with HIV-1 pretreatment was no longer effective and that showed resistance to inhibitors of reverse transcriptase non-nucleoside analogues (ITINN). Both studies examined the efficacy and safety of etravirina treatment in combination with an optimized base (TBO), which included darunavir / ritonavir. The data showed that 58.9% of patients treated with etravirina got an undetectable viral load (<50 copies / ml), compared with 41.1% of patients treated with placebo [p <0.0001], and 50% higher than the control group. The recommended dose of INTELENCE ® is 200 mg (two 100 mg tablets) taken orally twice daily after a meal. It is possible to dissolve the tablets in water.

In the pooled analysis of studies DUET 1 and DUET 2 to 48 weeks of treatment showed that about 80% of patients who are treated etravirina with two or more active drugs achieved undetectable viral load.

The incidence of neurological and psychiatric adverse events at 48 weeks of treatment with etravirina was similar to those receiving placebo. Also in people coinfected with hepatitis C and / or B, the appearance of adverse effects in the liver etravirina-treated group was similar to placebo.

The Ministry of Health through the General Directorate of Pharmacy and Health Products has just approved funding this new therapeutic alternative for adult patients infected by HIV-1 that have been previously treated with other drugs and who have generated a resistant virus. . "We had to wait almost 10 years to introduce a new ITNN, well tolerated, with a better resistance profile and able to rescue patients who had developed a certain level of resistance to the above. Means a significant improvement in the arsenal of treatments and an alternative to rescue the current ITNN in selected situations, "says Dr. Gatell. Ortega to the doctor, "with this new therapy is called the therapeutic range and it is likely that we are entering a new era of change in therapy initiation.

To etravirina marketing in Spain, more than 700 patients have been treated for compassionate use or expanded access program.


New horizons in the fight against HIV

The presentation of this new drug that takes place during the symposium "Improving the Present: Renovation and Innovation in the non-nucleoside" to be held this weekend in Valencia, brings together over 150 specialists on the occasion of the official presentation to the community etravirina medical and to discuss the new horizons that exist in the fight against HIV / AIDS. Dr. Gatell to "provide new therapeutic options for antiretroviral treatment changes make it simpler and better tolerated by patients and allows the possibility of developing a rescue treatment whose effectiveness is close to 100%." In the same line expressed that Dr. Ortega said that "the horizons of therapy are changing with the emergence of new drugs more effective and less adverse family therapy known to improve the existing ones and also acting against other targets of the virus hitherto impregnable. "

Etravirina was developed by Tibotec Pharmaceuticals, a Johnson & Johnson's group dedicated to research and development of new drugs in the area of virology. Janssen-Cilag International NV is the holder of the marketing authorization in the European Union. Spain INTELENCE ® is marketed by Janssen-Cilag SA,

Janssen-Cilag pharmaceutical company based in the research group belonging to the Johnson & Johnson, the multinational health sector more diversified and employs 119,000 people worldwide. For 120 years, Johnson & Johnson develops health care products and services for markets pharmaceutical, consumer and professional.