For more than 30 years, our company has been committed to addressing the global challenge of the HIV epidemic.
With over 35 million people infected and 2 million new infections each year globally, the challenges of HIV are vast, impacting both developed and developing countries. These challenges include scientific, behavioral and programmatic aspects that continue to change as the epidemic evolves.
Since 1985, we’ve been engaged in research and development efforts in both HIV prevention and treatment of HIV. These efforts continue today. But research is just one part of our comprehensive strategy to address unmet needs in combatting HIV.
Our company has also sought to make a difference in the fight against HIV through efforts to enhance access to our HIV medicines, particularly in the developing world, and through partnerships that seek to strengthen health systems to better deliver prevention and treatment services. Clearly, the need is too great for any one stakeholder to address, requiring coordinated efforts among many.
A Multifaceted Approach to Improving Access
We are committed to working with governments, donors, innovative and generic manufacturers, multilateral organizations, and civil society to address the full range of factors affecting access. After a decade of specific efforts to increase access to HIV treatment in the developing world, it is clear that access to care is about more than the price of medicines, and that collaboration has been essential to the progress made against HIV.
We have seen that increasing access requires a broad, comprehensive approach. Consequently, we are committed to improving patient access through expanded availability, enhanced access strategies and multi-sectoral partnerships.
To make these possible, we have employed multiple strategies to address the needs of particular regions and countries, including: seeking rapid and broad registration of our antiretroviral medicines (ARVs); providing support for clinical studies in resource-limited settings; implementing differential-pricing strategies; signing voluntary licenses with generic manufacturers; developing pediatric formulations; and establishing strong collaborations with governments, manufacturers and other stakeholders.
Focusing on Unmet Need in Pediatric Treatment
Most recently, we have worked to increase access to the pediatric formulations of raltegravir, our integrase inhibitor, in the areas of greatest need. We have developed several pediatric formulations of raltegravir, which, following clinical studies conducted in collaboration with the IMPAACT Network, have been approved by the U.S. Food and Drug Administration (FDA) for children as young as four weeks of age. Studies in infants below four weeks of age are ongoing.
Pediatric HIV treatment is an area where multi-sector efforts are needed to facilitate development of appropriate formulations and to promote manufacturing and supply of these pediatric formulations.
The burden of pediatric HIV falls primarily in sub-Saharan Africa and in lower-income countries. The lack of demand for pediatric HIV medicines in high-income countries provides little commercial incentive for the development of optimized pediatric combinations, such as those seen in adults. Given this, public-private partnerships are key mechanisms to facilitate availability of new pediatric formulations and to develop optimized formulations and combinations of pediatric ARVs.
Recognizing the particular challenges of addressing the needs of children with HIV, we recently entered into an agreement with the Medicines Patent Pool. The agreement is designed to improve access to raltegravir for pediatric populations in 92 low- and middle-income countries where 98 percent of the children infected by HIV live.
In February 2015, we announced an agreement with the Medicines Patent Pool (MPP) to license our pediatric formulations of raltegravir for use in treating HIV-1 infection in infants and children from 4 weeks to under 12 years of age in developing countries. This is the MPP’s first agreement to provide access to an HIV integrase inhibitor for use in combination HIV therapy for infants and children in this age range.
The agreement also allows for development of novel pediatric formulations of raltegravir and novel combinations—in support of the “Global Pediatric Antiretroviral Commitment-to-Action” announced by the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), the Pediatric HIV Treatment Initiative (PHTI); and the Global Fund to Fight AIDS, Tuberculosis and Malaria to accelerate the development of new, high-priority pediatric ARV co-formulations.
Multi-stakeholder efforts, including those of governments, civil society, donors and the private sector, are needed to address the challenges of delivering comprehensive HIV prevention, care and treatment.
We constantly strive to discover new ways to apply our expertise, human and financial resources, and market-based solutions to address the complex challenge of patient access. Our strategies are designed to enable us to facilitate access while continuing to develop new medicines. They also help us move beyond the limits of what we can achieve if we work alone.
This desire to redraw the boundaries of possibility enabled us to pave the way for two successful private-public partnerships that were created in the last two decades in some of the countries hit hardest by HIV. Learn more.
Enhancing Access in the Developing World
To facilitate access to raltegravir in sub-Saharan Africa and in low-income countries, the areas of greatest need and the least ability to finance health care, we instituted a multi-strategy model that includes developing a low-cost supply chain with manufacturing partners that has enabled us to reduce our Access price in sub-Saharan Africa, low-income countries and least developed countries (LDCs), and to grant nonexclusive voluntary licenses to multiple generic manufacturers to supply generic raltegravir in these regions.
Public-sector purchasers in the 62 countries that are considered the world’s poorest and hardest hit by the HIV and AIDS pandemic are eligible for our lowest price. According to the WHO, three-fifths of patients in need of therapy live in these countries.
The countries included are all countries currently identified by the United Nations Conference on Trade and Development (UNCTAD) as LDCs, as measured by their low income, weak human assets and high economic vulnerability. We are also extending our Access price to public-sector purchasers in those 12 countries in sub-Saharan Africa hardest hit by the HIV and AIDS pandemic but not yet included on the UNCTAD list. A complete list is available here.
Given the varying levels of economic development and national strategies, in other middle-income countries we have implemented strategies to make meaningful improvements in patient access. We are focusing on working with governments and with other country stakeholders to develop strategies tailored to each country’s HIV-access needs. As part of this effort, we have implemented a differential pricing policy based on country income level, disease burden, treatment-guideline position, patient access through national AIDS treatment programs, and market conditions. As conditions evolve, we continue to refine these country-specific models.
To truly enhance access to treatment in low- and middle-income countries, the international community must collaborate to strengthen health care infrastructure, to ensure adequate financing for health, and to help to build local health care capacity through training and support. Pharmaceutical companies alone cannot solve these immense public-health problems. Sustainable solutions will come from comprehensive approaches that draw on the expertise of all stakeholders.
Addressing Access Issues in the Developed World
In developed countries, we continue to work to address patient access needs. In the United States, for example, many state AIDS Drug Assistance Programs (ADAPs) have struggled to meet growing need. Over the last two decades, our company has lowered or frozen the price of its ARVs five times. We also continue to offer support to eligible patients through our comprehensive Patient Assistance Programs and Co-Pay Assistance Program. Since 2010, we have worked with Welvista and with HarborPath to offer immediate access to no-cost HIV medicines to patients on ADAP waiting lists and to support a common portal for patients accessing our company-sponsored Patient Assistance Programs (PAPs).
State Aids Drug Assistance Program (ADAP)
We have a long history of working closely with leaders from the HIV community to ensure that our approach to pricing our medications is fair and reasonable, balancing our interest in conducting extensive HIV research with efforts to support broad access to our medicines.
We were one of the first companies to provide our HIV medicines to uninsured patients on waiting lists for drugs under the AIDS Drug Assistance Program (ADAP). In addition, we were the first company to provide a price freeze for state ADAPs in the late 1990s, when they began to suffer a funding challenge.
We expanded our price-freeze policy to subsequent products, and also continue to provide expanded financial relief to state ADAPs through increased discounts. Through the agreement, which was extended through December 31, 2016, we provide continued support for initiatives that provide low-income individuals living with HIV with access to medicines.
ADAPs reach approximately one-third of people with HIV estimated to be receiving care nationally. The renewal of the existing special pricing program through 2016 was our fourth major ADAP response in five years.
SUPPORT™ Program in the U.S.
Our commitment to patients’ access to our products is reflected in our SUPPORT™ Program, which helps answer questions related to insurance coverage and provides free reimbursement support for patients who have been prescribed ISENTRESS®(raltegravir) or CRIXIVAN® (indinavir sulfate). A program specialist can also refer patients to the Patient Assistance Program, which provides ISENTRESS and CRIXIVAN free of charge to eligible patients. Our company’s Patient Assistance Program was designed primarily to help those who do not have insurance coverage; however, individuals who have insurance, including Medicare Part D, but still have trouble paying for their medicines may request that an exception be made, provided that their income is not above a set limit. Learn more.
Co-Pay Assistance Program in the U.S.
In addition to the SUPPORT™ Program, we have a program in the United States for eligible patients on ISENTRESS. If patients have private insurance and an out-of-pocket cost for ISENTRESS, they may be eligible to receive a savings coupon. The coupon provides savings toward their out-of-pocket costs. Restrictions, terms and conditions apply. Learn more.
Common Patient Assistance Program Application
We also participate in the national Common Patient Assistance Program Application (CPAPA) for HIV medications. The form was developed by the Department of Health and Human Services (DHHS), participating pharmaceutical companies, the National Alliance of State and Territorial AIDS Directors (NASTAD), and community stakeholders. The form can be used both by people living with HIV and by their providers, and reduces the need to complete several different and individual PAP application forms for HIV medications.
We continually look for ways to reduce the cost of our antiretrovirals (ARVs) for people living in the world’s poorest countries and those hit hardest by the epidemic.
One way is to work with external manufacturers and suppliers to achieve incremental efficiencies. For ISENTRESS® (raltegravir), we have established a low-cost supply chain with external partners for commercialization in all low-income countries and all countries in sub-Saharan Africa.
With the implementation of this supply chain, we have been able to reduce our price of ISENTRESS to $1.85 per day in these countries. We have also granted multiple nonexclusive licenses to several Indian generic manufacturers for the manufacture and commercialization of the 400mg tablet formulation of raltegravir in 60 low-income and sub-Saharan African countries. In addition, in February 2014, together with Cipla, we announced a strategic partnership to co-market raltegravir (400mg tablet) in the Indian market.
In February 2015, together with the Medicines Patent Pool (MPP), we announced a licensing agreement for pediatric formulations of raltegravir for children less than 12 years of age covering 92 low- and low-middle-income countries.
To date, we have also granted royalty-free licenses for efavirenz to six South African generic manufacturers.
HIV Pricing Policies
Our differential-pricing policy is part of our commitment to addressing HIV through a multi-pronged strategy, with the goal of ensuring that our HIV antiretroviral (ARV) medicines reach as many of those in need as possible.
ISENTRESS®, STOCRIN®, CRIXIVAN®
The lowest Access price for our HIV medicines is offered to countries with a combination of highest disease burden and lower country income (gross national income [GNI] per capita), as defined by the World Bank. A list of eligible Access countries is provided here.
As of July 1, 2015, the Access prices for our HIV medicines for eligible customers1 are:
|Drug Name||Daily Dose||Pricing $ per unit|
|50mg tablet||4 (200mg)||169 (0.12)|
|200mg tablet||3||394 (0.36)|
|600mg tablet||1||237 (0.65)|
|30mg/ml suspension (bottle)||9ml||310 (0.094)|
|30mg/ml suspension (bottle)||12ml||413 (0.094)|
|400mg cap||4||394 (0.27)|
|400mg tablet||2||675 (0.925)|
|100mg chewable tablet||based on weight||(0.60)|
|25mg chewable tablet||based on weight||(0.30)|
Countries classified as lower-middle-income and upper-middle-income2 by the World Bank are eligible for prices that are discounted from those in high-income countries. These prices are based on, among other things, a combination of country income, disease burden, treatment guideline positioning, patient access through national AIDS treatment programs and market conditions, and will be negotiated with each government. For high-income countries, we will make ISENTRESS available at competitive prices that take into account the innovation and value that ISENTRESS represents.
We sell ATRIPLA® (efavirenz/emtricitabine/tenofovir disoproxil fumarate) at $1.68 per day, or $613 per year, in 98 Access countries, as defined by our agreement with Gilead.
1 Customers eligible for public-sector Access pricing in eligible Access countries will include: governments and programs fully funded by governments and/or by multi- and bilateral donors (e.g., the Global Fund, PEPFAR, UNITAID); UN System organizations; NGOs and other noncommercial providers of HIV treatment in sub-Saharan Africa; World Bank–defined low-income countries, UN-defined least-developed countries and India. We offer these products on a Delivered Duty Unpaid (DDU), Carriage and Insurance Paid (CIP), or Carriage Paid To (CPT) airport-of-destination (Incoterm, 2000) basis. Additional costs may include freight, insurance, customs handling, taxes and duties.
2 Customers eligible for public-sector pricing in lower-middle and upper-middle income countries will include: governments and programs fully funded by governments and/or by multi- and bilateral donors (e.g., the Global Fund, PEPFAR, UNITAID); UN System organizations; and NGOs. Low- and middle-income countries that are members of the European Union are not eligible for pricing under this Access program.
We are committed to pursuing rapid registration of our antiretrovirals (ARVs), including registration in those countries most affected by HIV/AIDS. Currently, our ARVs are registered or available through import waiver in many countries. Since the first approval in 2007, ISENTRESS® (raltegravir) has received regulatory approval in more than 100 countries.
Details of registration and availability of our four ARVs are available through the links below:
- ATRIPLA® (efavirenz, emtricitabine, tenofovir disoproxil fumarate)
- CRIXIVAN® (indinavir sulfate)
- ISENTRESS® (raltegravir)
- STOCRIN® (efavirenz)
- ISENTRESS, STOCRIN, CRIXIVAN and ATRIPLA have received World Health Organization (WHO) prequalification. WHO prequalification verifies that medicines meet the quality, safety and efficacy requirements of UN agencies, including UNICEF and the Pan American Health Organization. All of our company’s formulations of ISENTRESS, including the 400mg tablet, the 100mg and 25mg chewable tablets, and the granules for suspension, have been approved by the U.S. Food and Drug Administration (FDA) and the European Medical Agency, making these formulations eligible for purchase by both the U.S. PEPFAR program and the Global Fund to Fight AIDS, Tuberculosis, and Malaria.
Improving access to care requires more than simply making our medicines available and affordable.
The most important factors for long-term sustainability are strengthening health care infrastructure, ensuring adequate financing for health, and helping to build local health care capacity through training and support. Public-private partnerships have a critical role to play in this process, drawing on the complementary expertise of all stakeholders—governments, international agencies, community organizations, donors, the private sector, nongovernmental organizations (NGOs), patients and others—to identify the most promising and efficient ways to address the impact of HIV in a variety of resource-limited settings.
Learn more about our partnerships to address the challenge of HIV.
Our company has had an intensive, broad-based HIV clinical research program in place since 1985 that has sought to address both treatment and prevention.
In addition to our own research efforts, we have entered into collaborations with other researchers and scientific organizations to help accelerate the search for new treatments and possible cures. Our work has been pioneering, and was pivotal in the development of new antiretroviral (ARV) treatments including protease inhibitors (PIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs) and integrase inhibitors. We have also played an important role in collaboration with others to define the principles for combination ARV treatment that are the standard for today’s treatment paradigm.
Our HIV Research Efforts
- In the mid-1980s, soon after the public health community first coined the term “AIDS” to describe the emerging epidemic, our company began its HIV/AIDS research. Our scientists were the first to describe the chemical structure of the protease enzyme, and published the findings immediately to encourage further research efforts. They then developed CRIXIVAN® (indinavir sulfate), an HIV protease inhibitor, which was approved by the European Medicines Agency and the U.S. Food and Drug Administration (FDA) in 1996. At the time, the FDA’s approval of CRIXIVAN was the fastest approval in FDA history.
- In 1997, our company’s clinical study of CRIXIVAN was the first to show that a combination of antiretroviral medicines could provide prolonged suppression of HIV RNA. Today, CRIXIVAN in combination with antiretroviral agents is indicated for the treatment of HIV infection.
- In 1999, we introduced efavirenz, a non-nucleoside reverse-transcriptase inhibitor (NNRTI), which was developed with DuPont Pharmaceuticals. Our company retained the rights to market efavirenz in select markets outside the United States. Today, efavirenz is one of the most commonly prescribed antiretroviral therapies worldwide.
- In the early 1990s, our company was the first to demonstrate that inhibition of the HIV-1 integrase enzyme—which is required for HIV replication—was possible, and that inhibiting the integrase protein reduced replication and spread of the virus. This research advancement led to the development of ISENTRESS® (raltegravir). In 2007, the approval of ISENTRESS introduced a new class of treatments, HIV-1 integrase strand transfer inhibitors. Today, ISENTRESS is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in patients four weeks of age and older. The use of other active agents with ISENTRESS is associated with a greater likelihood of treatment response.
- In addition, since the mid-1980s, shortly after the HIV virus was identified, our company pursued one of the largest HIV vaccine research programs, culminating in a large-scale trial that illustrated the difficulty of developing a successful HIV vaccine.
We continue to focus on comprehensive research and development that targets HIV, recognizing the need for new methods to address the epidemic. Our current R&D work in HIV includes programs to develop novel HIV-prevention technologies, new HIV antiretroviral medicines, and approaches to addressing HIV latency and eradication.
We have an active HIV R&D program to develop new HIV antiretroviral medicines that address unmet needs in HIV treatment. Among the clinical development programs currently underway are the development of a once-daily formulation of raltegravir, currently in Phase III trials, a novel second-generation non-nucleoside reverse transcriptase inhibitor in Phase III, and several earlier-stage clinical development programs, demonstrating our ongoing commitment to HIV therapeutic R&D.
As part of the company’s commitment to fighting HIV/AIDS, we have conducted extensive research and development (R&D) efforts to bring forth pediatric formulations for our HIV antiretrovirals (ARVs).
In 2007, we began collaborating with the National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Child Health and Human Development (NICHD) and the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network to conduct a Phase I–II, multicenter, open-label, noncomparative study to evaluate the safety, tolerability, pharmacokinetics and antiretroviral activity of ISENTRESS® (raltegravir) in children and adolescents: IMPAACT P1066. This study of three formulations—a film-coated tablet, a chewable tablet and granules for oral suspension—included more than 150 HIV-infected children ranging from 4 weeks to 18 years of age in the U.S., Latin America and Africa.
On the basis of results from this study, three formulations of ISENTRESS have now been approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency for use in infants (as young as 4 weeks of age and weighing at least 3 kg), toddlers, children or adolescents. Both the chewable tablets and the granules for suspension are dosed based on weight.
Also in collaboration with IMPAACT, we are conducting multiple studies in neonates. IMPAACT P1097, which examined raltegravir levels in full-term infants born to mothers who have taken raltegravir in pregnancy (these infants were not given raltegravir directly), has completed enrollment. A new component of this study (P1097A) is ongoing, and is similarly examining raltegravir levels, but this time in low-birth-weight (including preterm) infants whose mothers have taken raltegravir in pregnancy. Building from the data generated in P1097, another study, IMPAACT P1110, of active raltegravir dosing to neonates at high risk for acquiring HIV infection, was initiated and has provided preliminary data to establish a well-tolerated and appropriate dose of raltegravir (granules for suspension formulation) for neonates from birth to 6 weeks of age. Final results of this study are anticipated to support the use of raltegravir from birth both as prophylaxis of mother-to-child transmission and as treatment of HIV-1 infection.
Efforts to register these three formulations of raltegravir broadly in the countries with the greatest pediatric HIV burden are ongoing. And as of October 2014, the pediatric formulations are registered in more than 45 countries.
The burden of pediatric HIV falls primarily on sub-Saharan Africa and on low- and lower-middle income countries. The lack of demand for pediatric HIV medicines in high-income developed countries provides little commercial incentive for the development of pediatric optimized combination formulations, such as the optimized combination formulations for adults. In May 2014, UNITAID—in cooperation with the Medicines Patent Pool (MPP) and the Drugs for Neglected Diseases initiative (DNDi)—announced an integrated partnership intended to increase access to pediatric HIV treatment by developing improved or new pediatric formulations of HIV medicines. In support of this initiative, we announced that we had entered into negotiations with the MPP for licenses for the pediatric formulations (chewable tablets and granules for suspension) of raltegravir.
In February 2015, we entered into an agreement with the MPP allowing for supply of generic pediatric raltegravir formulations in 92 low- and middle-income countries, where 98 percent of children infected by HIV live. Read the full press release.