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Spain, August of 2011- the emergence of generic in the treatment of HIV infection could compromise the use of co-formulaciones, i.e. the combination of several drugs in one pill, which has been one of the great advances in terms of simplicity and compliance by the patient.

The co-formulaciones been proven effective to avoid medication errors and prevent that to be one of the drugs separately, hampering the development of resistance of the HIV virus to treatment.

The introduction of the generic of one of the included compounds would compromise the use of the co-formulaciones, which would be a “step backwards” for the quality of life of the patient, achieved thanks to the simplicity of the treatments. Thus claim it the most relevant Spanish experts group in the field of HIV, including the Dres. Josep M. Llibre, Santiago Moreno or Bonaventura Clotet, who have published their conclusions in a document of consensus in the prestigious journal AIDS.

“The emergence of generic is allowed once the original drug patent expires.” Usually it involves automatic replacement of one by another drug and is welcome to reduce the price of medicines. ’’ But in the case of the co-formulaciones, when expire the patent of only one of the included drugs, if you want to manage the new generic should “break” combination and administer drugs separately,”says El Dr. Josep María Llibre, who has led the development of the document.

Advances in research

The treatment of HIV infection has been one of the most dynamic of late 20th century research fields. Began taking 20 tablets distributed in 3-4 daily intakes, schemes a situation which greatly hindered the correct treatment compliance. The research allowed reducing the number of shots, pills and improve their tolerance. Finally, the arrival of the co-formulaciones was one of the great advances in the treatment of HIV, that the patient only needed for taking a single pill that already included different drugs, sometimes containing all the necessary treatment for the whole day. Furthermore, became apparent that the co-formulaciones also reduce the risk to the developing resistance to antiretroviral drugs.

The creation of co-formulaciones required a thorough investigation which reached the same level of safety and effectiveness in the administration of the drugs separately, avoiding at the same time you interactions between different medications. The main beneficiaries were the patients who improved their quality of life with treatments which facilitated adherence and minimizing errors.

Fewer hospital admissions

Research highlights the specific characteristics of the HIV cause that loss of adherence to result in an increased risk of hospitalization, with the impact that this represents for the health of the individual, both for the economic costs of his treatment. “Advances in co-formulación have been a cost savings derived from the improvement in adherence to treatment, reducing errors and failures of treatment, with all its consequences.” If the generic aims precisely to reduce the costs of drugs once its patent has expired, in antiretroviral co-formulaciones return to the Administration separately from the included drugs could lead to increased costs in the long term than those who seek to reduce by replacing one of the components as generic. “These costs are associated with a greater number of errors, failures, failures of treatment and finally, development of specific antiviral resistance,” says Dr. Josep M. Llibre.

Demands to the authorities and the pharmaceutical industry

Therefore, the Group of researchers, the doctors Josep M. Llibre, José r. Arribas, Pere Domingo, Josep M. Gatell, Fernando Lozano, José r. Santos, Antonio Rivero, Santiago Moreno and Bonaventura Clotet, concludes the study stating that “both health authorities and the pharmaceutical industry should be to agree to preserve the use of co-formulaciones when the introduction of a generic equivalent to one of the drugs” “including puts at risk the disintegration of his administration on different tablets”.

Perspective of the patient

According to Ferran Pujol, President of the names project NGO, “have been many years needed to be able to have a treatment appropriate, simple and compatible with everyday life.” In our case a simple error or forgetfulness may result in significant consequences on our health. And with the co-formulación we managed to minimize such risks. “Now the entry of generics is an involution which affected principals are patients”.

Research of the Spanish expert group effectively refers to several studies have shown that interruptions in treatment are associated with an increase in the occurrence of opportunistic infections and other inflammatory in this type of patient nature. At the same time, the emergence of new disorders more expensive cost and toxicity of antiretroviral drugs when administered uninterruptedly. And this happens most frequently when the treatment consists of various medications administered separately.

Co-formulaciones hypertension and TB

The reduction in the number of tablets and doses patients of chronic diseases should be handled is not news of HIV infection. It is a priority to reduce errors in the Administration and improve adherence to treatment which has already shown previously in hypertension. The American Society of hypertension has been sympathetic to the preferential use of co-formulaciones as a practice necessary to improve the effectiveness of treatments.

The treatment of tuberculosis is also another example to be taken into account. The use of co-formulaciones in this condition not only improves adherence to treatment, but it also avoids the appearance of bacterial resistance to any of the drugs administered separately. In this regard, who and the International Union against Tuberculosis and lung disease recommend the use of co-formulaciones to ensure optimal treatment and prevent the development of resistance by the causative agent of tuberculosis.