- ALEJANDRA HERNÁNDEZ
21 de mayo de 2016 00:29 AM
Since the last quarter of 2009 until April 2016, government dispensation of HIV drugs has been met with a series of failures that endanger health, and in some cases even threaten the lives of at least 61,686 patients who, according to the Ministry of Health, receive free treatment. Non-profit groups advocating for and defending the rights of persons living with HIV/AIDS, fear the situation could become much worse in the second half of 2016, urging the Ministry of Health to take the necessary measures to avoid further stock outs.
In the first four months of 2016, at least three or four of 30 types of antiretroviral (ARV) drugs dispensed in Venezuela were not available to people living with HIV/AIDS, according to data collected by local NGO StopVIH. In January and February the patients reported the stock out of Viraday, Truvada and Nevirapine; while in March and April they reported stock-outs of Enfuvirtide (Fuzeon), Raltegravir (Isentress), Rilpivirine (Complera) and Viraday (Atripla).
A monitoring by the focal points in the National Network of People Living with HIV/AIDS in the 24 regions of the country, shows that at the Venezuelan Institute of Social Security (IVSS) pharmacies for high cost drugs, where many of the most expensive and critical medicine are dispensed, there are stock-outs of T-20 (Fuzeon), Raltegravir (Insentress), Nevirapine (Viramune) and Darunavir (Prezista). As for Kivexa, already out of stock, its two components (Abacavir and Lamivudine) are dispensed separately. Oral solution drugs for HIV-infected children as Kaletra and Abacavir are also out of stock, said local NGO Acción Solidaria (Solidarity Action) in a press release published on May 3.
However, the Health Ministry said all antiretroviral drugs are readily available, “except for one, of which there is one month of stock left,” said a source close to Minister Luisana Melo, who asked not to be identified. We have learned unofficially that the drug the source referred to was Raltegravir.
Intermittent stock-out episodes
While one cannot speak of an absolute shortage of antiretroviral drugs in Venezuela, over the last six and a half years drugs supply has occurred intermittently, says the president of StopVIH, Jhonatan Rodriguez. As he explains, these deficits are caused by failures in distribution in some states, and also by the disappearance of some drugs for a certain period, eventually showing up again. The crisis also extends to drugs against AIDS-related opportunistic infections.
Even if temporarily, non-availability of drugs endangers the health of HIV positive people, Rodriguez explains, as the unplanned interruption in their drug regimen causes the effect of the drug - to prevent the virus from replicating - to be lost, allowing the virus to acquire resistance to the medications and mutating, forcing patients to use other drugs often with greater side-effects. Hence the importance for HIV patients to receive their medications exactly as prescribed.
But for some years now this desideratum has not been achievable. In 2010-2011 at least 37 stock-out episodes occurred in the country, with Venezuela being ranked first in Latin America on ARV stock-outs, according to a report entitled “Antiretroviral Treatment in the Spotlight: A Public Health Analysis in Latin America and the Caribbean 2012,” published by the Pan American Health Organization (PAHO) and the World Health Organization (WHO). Another 16 stock-out episodes were recorded in 2012, with Venezuela again topping Latin America on ARV stock-outs, according to a similar PAHO/ WHO report published in 2013.
But the most critical year of all was 2014, when there were stock-outs of several drugs for most of the year and in some cases, as in the months of March and May, at least 16 of the 30 ARV drugs were not available, including Truvada, Reyataz, Kivexa, Lamivudine, Abacavir, Duovir, Efavir, Ritonavir, Foamprenavir, Darunavir, Kaletra, Nevirapima, Tenofovir, Raltegravir, Viraday and Complera, as reported to StopVIH by patients.
In August 2014 there were stock-outs of at least 15 drugs, 14 in April, 10 in June, 9 in September, 7 in July, 6 in February, 4 in January, 3 in December and 2 in November. Stock-outs occurred all year round during 2015, but of fewer drugs.
In the eye of the storm
Drugs for the treatment of HIV/AIDS are imported and very expensive. Some, such as Truvada (Entracitabina +Tenofovir), can fetch up to USD 800. Since 2002, mandated by the Constitutional Chamber of the Supreme Court, acquisition and dispensation of these drugs has been conducted directly by the State through the Ministry of Health, which in turn redistributes them in the 26 IVSS high cost pharmacies throughout the country, to make them available to patients. It is for this reason that both Rodriguez and Feliciano Reyna, President of NGO Solidarity Action, claim that providing antiretroviral depends solely on the state.
A couple of years ago, institutions like the Artistas por la Vida (Artists for Life) Foundation and the Badan Foundation kept stocks of some antiretroviral drugs, but today the situation is completely different. Badan Foundation CEO Jose Ignacio Araque said that they have no HIV drugs in stock since last year.
Since 2014, the Ministry of Health has acquired HIV drugs through the Strategic Fund for medicines procurement, managed by the PAHO. The procurement process is very complex and takes about 9 months because it consists of several stages, therefore, the Ministry needs to place the order of antiretroviral drugs well in advance so that the drugs can arrive on time.
However, the secretary general of Red Venezolana de Gente Positiva (Venezuelan Network of Positive People /RVG +), Estevan Colina, reported last April that the Venezuelan government had not placed a new purchase order to the Strategic Fund, as he learned during a meeting with representatives of the PAHO in Venezuela. He said that several of the drugs supplied by the Autonomous Service of Pharmaceutical Elaborations (SEFAR) have already stocked out or are close to stock out, since the last supply was for a 15-month period ending on May this year.
The directors of the three HIV/AIDS advocacy organizations blamed Health Minister Luisana Melo for this situation, as “she did not sign the 2016 ARV purchase orders for the amount of USD 35 million.”
Solidarity Action delivered a statement to the press stressing that "the serious negligence by the Health Minister caused the administrative continuity started by her predecessor, Minister Henry Ventura - who in November 2015 had begun the process established with the Strategic Fund by delivering the ARV procurement management planning and other required technical information - to be interrupted."
In light of this situation, a group of 10 or more representatives of HIV/AIDS advocacy organizations held a special meeting last Tuesday with Indira Corado, an assistant to Minister Melo, to find out the status of the next provision of ARVs. The group was informed that "the general ARV situation would be resolved and that, in cases where there are failures, these were already being resolved.” However, HIV/AIDS advocates left the meeting feeling that they needed more information to make sure that the drugs would be available as soon as possible.
Feliciano Reyna, the president of Solidarity Action, said that during the meeting the officials of the Ministry of Health admitted that in mid-June there could be momentary stock-outs of Raltegravir, but they assured that by the end of June the problem would be solved. "I won’t be satisfied until I see that schedule," said Reyna.
We learned off-the-record that the Venezuelan government activated the ARV procurement mechanism last April; however, as the process takes many months and the available inventory will run out in June, allegedly the PAHO would be negotiating with countries that are in line to receive medication to allow Venezuela to be the first to stock up to avoid discontinuation of treatment by HIV patients.
The stock out of ARVs is not the only flaw in the comprehensive HIV/AIDS patient care and treatment system. The crisis also has an impact on the testing materials for the diagnosis, control and monitoring of HIV/AIDS.
The Venezuelan Society of Infectious Diseases (SVI) delivered a statement to the press on May 5 denouncing that the “Rafael Rangel” National Institute of Hygiene, which centralizes the vast majority of diagnostic tests for HIV patients, has since 2015 been faced with “a shortage of the reagents and/or technology required for processing viral loads and antiretroviral drug-resistance testing, which are essential for proper patient care."
Additionally, unavailability of milk and baby formula threatens the health of babies born to HIV-positive mothers, as HIV can be transmitted to the baby from breast milk.
Translated by Sancho Araujo