The antiretroviral Dolutegravir has been incorporated in Brazil’s National Antiretroviral Treatment Guidelines an option for first line treatment, as announced recently through the decree nº 35, issued by the Ministry of Health of Brazil, along with the scale-up of the antiretroviral Darunavir as a second line treatment.
In ABIA’s view, adopting Dolutegravir on initial treatment and authorizing the use of Darunavir in second line regimens are crucial measures that will improve treatment adherence for recently diagnosed people. This will have a significant impact in the assurance of the right to health and wellbeing of people living with HIV.
ABIA, together with other civil society organizations, has been denouncing the impact of side effects on adherence to treatment and demanding that quality of life for people living with HIV be seen as a priority in treatment strategies.
At the moment the decree was announced, ABIA and the Working Group on Intellectual Property (GTPI) – a collective of organizations and activists coordinated by ABIA – were hosting the seminar ‘Access to Medicines and Human Rights Policies’.
The seminar took place over three days (26-28 September) and was focused on expanding the use of new drugs for low prices, including Dolutegravir and Darunavir. Civil society, academics, industry, and decision-makers, including the Head of the STD, AIDS and Viral Hepatitis Department (DDAHV) attended the seminar.
Pressure
In January 2015, ABIA/GTPI sent a letter to the Ministry of Health demanding the initiation of a procedure at the National Commission of Technological Incorporations (CONITEC) to evaluate the incorporation of Dolutegravir in the Public Health System. The letter also demanded the use of measures to protect public health (TRIPS flexibilities) to reduce prices and offer the drug to everyone.
Subsequently, ABIA/GTPI held meetings both with the Ministry of Health and with the supplier of the drug, GlaxoSmithKline, to push for price reduction and accelerated incorporation. In July 2015, CONITEC issued a decision against the incorporation of Dolutegravir based on its high price. Therefore, ABIA/GTPI gathered technical data and clinical evidence that reinforced the importance of the drug both as salvage therapy (3rd line treatment) and as an option for initial treatment, drawing on evidence from other countries.
In October 2015, CONITEC issued a new decision, at this time in favor of the incorporation, but only as salvage therapy. In the decision, CONITEC clarified that the incorporation would be on the condition of the price reduction proposed by Glaxo, R$ 31,82 per unit (U$9,88).
In the same month, ABIA/GTPI organized the multi-stakeholder dialogue ‘Access to ARVs’, in which Dolutegravir was one of the main topics of discussion. On this occasion, DDAHV declared that it would be impossible to address civil society demand to offer Dolutegravir as initial treatment.
In November 2015, ABIA/GTPI, organized a debate in João Pessoa about the incorporation of new medicines, on the eve of the 10th Brazilian Congress of HIV/AIDS. In addition, ABIA/GTPI organized with partners a protest at the opening session of the Congress to denounce the high prices of the drugs and the abuses of the patent system.
Price
In December 2015 ABIA/GTPI organized a treatment workshop at the 18th National Meeting of Networks, Movements and NGOs (ENONG). Activists from all over the country were called on to strengthen the debate about prices and quality of antiretroviral drugs. At this time, the Ministry of Health figures indicated that 74% of prescriptions for initial treatment were based on the “3 in 1” regimen (EFV/TDF/3TC), and the plan was to initiate another 190,000 people on the same therapy by 2020.
Following the workshop, civil society groups agreed that instead of a large investment in only one therapeutic option, it was necessary to seek new treatment options with human rights and quality of life as the guiding principles.
Therefore, the plenary of ENONG approved a motion in favor of the inclusion of Dolutegravir for initial treatment and a demand for the expanded and frequent use of measures to protect public health (TRIP flexibilities) to reduce prices of key drugs.
After the workshop, ABIA/GTPI received criticism from the Ministry of Health and international agencies, that stated the civil society demands for revisions in the Brazilian treatment protocols were exaggerated. Since then, civil society has intensified the call for update of the treatment guidelines, in conformity with law 9313. Civil society has been also pushing for the inclusion of integrase inhibitors (the class of Dolutegravir) as an option for initial treatment, as already happens in many other countries.
Standing strong against pressure
With regards to Darunavir, ABIA emphasises the importance of the prices achieved through the joint negotiation at Mercosul level, in order to ensure the use of the drug in second line is actually sustainable. This includes standing strong against any pressure coming from the company Janssen and from the association that defends its interests, such as Sindusfarma, that try to promote the view that Brazil has no right to purchase generic versions.
With regards to Dolutegravir, the price that last year was around R$31,82 per unit (U$9,88) has dropped to R$6,02 (U$1,53). But while Brazil pays U$558 per patient/year, generic versions at U$44 were already announced. Therefore, to keep the prices constantly falling, it is necessary to make negotiations more transparent, improving civil society participation, and also to ensure a rigorous examination of patent applications, to avoid unmerited monopolies that will not only block the purchase of generics but also block the combination of this drug with others.
The fight against the epidemic goes on. ABIA/GTPI will keep calling for debates around the use of TAF, lesser toxic version of the drug Tenofovir, which is widely used in Brazil and is in the public domain thanks to public mobilization and civil society interventions. ABIA/GTPI will also keep fighting for sustainable prices for Truvada, an important drug for the advancement of combined prevention strategies.
For all those reasons, ABIA/GTPI consider the publication of the decree nº35 an important commitment, resulting from a wide social mobilization, which has always been the main pillar of the advancements in the fight against HIV/AIDS in Brazil.