Dolutegravir, an alternative first-line HIV treatment for low- and middle-income countries
Two years after its launch, NAMSAL (New Antiretroviral and Monitoring Strategies in HIV-infected Adults in Low-income countries), by the French Agency for Research on AIDS and Viral Hepatitis (ANRS), is yielding its first results. Conducted in Yaoundé (Cameroon), the study aims to compare the efficacy of two first-line treatments for HIV infection in more than 600 participants. The results of the trial, coordinated by Dr Charles Kouanfack (Yaoundé Central Hospital, Faculty of Medicine and Pharmaceutiques Sciences of Dschang University) and Pr Éric Delaporte (TransVIHMI, Montpellier University, Research and Development Institute (IRD) and French National Institute of Health and Medical Research (INSERM)), show that dolutegravir-based treatment is not inferior to treatment with efavirenz (400 mg). In the specific context of treatment for people living with HIV in Southern countries, the researchers believe that first-line treatment with dolutegravir is a good alternative to efavirenz. The findings of the study, co-funded by Unitaid and ANRS, are being presented at the HIVDrugTherapy Conference in Glasgow on Wednesday, 31 October 2018.
The latest World Health Organization (WHO) recommendations published in July 2018, advocate first-line treatment of HIV infection using dolutegravir[1] (DTG) as an alternative to treatment with efavirenz 400 mg (EFV400)[2].
Until now, no clinical trial data have been collected to directly compare the efficacy of the two drugs in the specific context of low-income countries.
The ANRS NAMSAL study has compared the effect of both DTG and EFV with 613 participants living with HIV who had not previously received ARV treatment.
According to Unitaid Deputy Executive Director Dr Philippe Duneton: “This trial is the first of its kind to supply comparative data on the use of dolutegravir in people living with HIV in low-income countries such as Cameroon. Unitaid values the great importance of the partnership with ANRS and WHO, because it will accelerate access to better HIV treatment.”
The participants in the ANRS NAMSAL trial were randomly divided into two groups. The first group followed a DTG-based regimen, while the second followed a EFV400-based regimen. After 48 weeks, 74.5% of the DTG participants and 69% of the EFV400 participants presented with an HIV plasma viral load of below 50 copies per ml of blood.
This shows that DTG-based treatment is not inferior to EFV400-based treatment. The fact that dolutegravir is not inferior to efavirenz 400 has been demonstrated.
The observed difference between the two treatments was not significant enough to assert the superiority of either regimen over the other. Moreover, participants showed similar tolerance to both treatments.
DTG is thus considered a valid treatment option in first line in the context of treating people with HIV in low and middle-income countries.
According to Professor Éric Delaporte: “In patients presenting with a high viral load in their blood at the start of treatment, we observed persistently low viral replication rates in both prescribed treatments (DTG and EFV). Hence, it is important to continue long-term monitoring of the patients who initiated DTG treatment to confirm the absence of resistance mutations to this drug; the trial will continue until 2021”.
“We welcome the results from this important research”, said Dr Gottfried Hirnschall, WHO’s Director for HIV and hepatitis. “The ANRS NAMSAL study supports joint efforts being made by WHO and Unitaid to optimize HIV treatment and to identify ever better and safer treatments for people living with HIV”.
The ANRS New Antiretroviral and Monitoring Strategies in HIV-infected Adults in Low-income countries (NAMSAL) trial launched in July 2016 is being conducted in Cameroon at three hospitals in Yaoundé: The Central Hospital, the Military Hospital and the Cité Verte district hospital. It will continue until 2021. It included more than 600 participants infected with HIV who had never had antiretroviral treatment. The aim was to compare the efficacy, tolerance and cost of the two first-line antiretroviral treatments, efavirenz 400 mg and dolutegravir. The trial is being promoted by ANRS and coordinated by Dr Charles Kouanfack (Faculty of Medicine and Pharmaceutiques Sciences of Dschang University) and Pr Éric Delaporte (TransVIHMI). It is co-funded by ANRS and Unitaid.
Information briefings on the study findings will be organized for representatives of communities of people living with HIV and civil society. Please contact Unitaid for more information at mascheronisa@unitaid.who.int
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[1] With a note of caution on the use of DTG in the periconception phase and for women and teenage girls of childbearing age, considering the possible risk of malformation of the neural tube when DTG is used during the first three months of pregnancy.
[2] EFV 400 is better tolerated than EFV 600, which is normally prescribed, and it is also available in fixed-dose combination tablets.
Sources:
Dolutegravir- versus an efavirenz 400mg-based regimen for the initial treatment of HIV-infected patients in Cameroon: 48-week efficacy results of the NAMSAL ANRS 12313 trial
Amandine Cournil1, Charles Kouanfack2,3, Sabrina Eymard-Duvernay1, Serra Lem3, Mireille Mpoudi-Ngole4, Pierrette Omgba5, Serge Tchokonte2, Ginette Edoul Mbesse6, Eitel Mpoudi-Ngole4, Alexandra Calmy7, Eric Delaporte1,8, for the NAMSAL study group 1. TransVIHMI, Montpellier University, IRD, INSERM, Montpellier, France, 2. Central Hospital, Yaoundé, Cameroon, 3. ANRS, Yaoundé, Cameroon, 4. Military Hospital, Yaoundé, Cameroon, 5. Cité Verte Hospital, Yaoundé, Cameroon, 6. PreVIHMI International Joint Laboratory, IRD, CREMER, Yaoundé, Cameroon, 7. Geneva University Hospitals, Geneva, Switzerland, 8. University Teaching Hospital, Montpellier, France
Global health organizations commit to new ways of working together for greater impact
Berlin – Eleven heads of the world’s leading health and development organizations today signed a landmark commitment to find new ways of working together to accelerate progress towards achieving the United Nations’ Sustainable Development Goals.
Coordinated by the World Health Organization, the initiative unites the work of 11 organizations, with others set to join in the next phase.
The commitment follows a request from Chancellor Angela Merkel of Germany, President Nana Addo Dankwa Akufo-Addo of Ghana, and Prime Minister Erna Solberg of Norway, with support from United Nations Secretary-General Antonio Guterres, to develop a global action plan to define how global actors can better collaborate to accelerate progress towards the health-related targets of the 2030 Sustainable Development Agenda.
“Healthy people are essential for sustainable development – to ending poverty, promoting peaceful and inclusive societies and protecting the environment. However, despite great strides made against many of the leading causes of death and disease, we must redouble our efforts or we will not reach several of the health-related targets,” the organizations announced today at the World Health Summit in Berlin. “The Global Action Plan represents an historic commitment to new ways of working together to accelerate progress toward meeting the 2030 goals. We are committed to redefine how our organizations work together to deliver more effective and efficient support to countries and to achieve better health and well-being for all people.”
The group has agreed to develop new ways of working together to maximize resources and measure progress in a more transparent and engaging way. The first phase of the plan’s development is organized under three strategic approaches: align, accelerate and account.
Align: The organizations have committed to coordinate programmatic, financing and operational processes to increase collective efficiency and impact on a number of shared priorities such as gender equality and reproductive, maternal, newborn, child and adolescent health.
Accelerate: They have agreed to develop common approaches and coordinate action in areas of work that have the potential to increase the pace of progress in global health. The initial set of seven “accelerators” include community and civil society engagement, research and development, data and sustainable financing.
Account: To improve transparency and accountability to countries and development partners, the health organizations are breaking new ground by setting common milestones for nearly 50 health-related targets across 14 Sustainable Development Goals. These milestones will provide a critical checkpoint and common reference to determine where the world stands in 2023 and whether it is on track to reach the 2030 goals.
The Global Action Plan will also enhance collective action and leverage funds to address gender inequalities that act as barriers to accessing health, and to improve comprehensive quality health care for women and girls, including sexual and reproductive health services.
The organizations that have already signed up to the Global Action Plan for Healthy Lives and Well-being for All are: Gavi the Vaccine Alliance, the Global Fund to Fight AIDS, Tuberculosis and Malaria, the Global Financing Facility, UNAIDS, UNDP, UNFPA, UNICEF, Unitaid, UN Women, the World Bank and WHO. The World Food Programme has committed to join the plan in the coming months.
The final plan will be delivered in September 2019 at the United Nations General Assembly.
For more information, www.who.int/sdg/global-action-plan
Media enquiries
Gavi, the Vaccine Alliance : Frédérique Tissandier; +41 79 300 8253; ftissandier@gavi.org
Global Fund: Ibon Villelabeitia; +41 79 292 5426; ibbon.Villelabeitia@theglobalfund.org
UNAIDS: Sophie Barton-Knott; +41 79 514 6896; bartonknotts@unaids.org
UNDP: Adam Cathro; +19179159725; adam.cathro@undp.org
UNFPA: Omar Gharzeddine; +1 212 297 5028; gharzeddine@unfpa.org
UNICEF: Sabrina Sidhu; +1 917 476 1537; ssidhu@unicef.org
Unitaid: Andrew Hurst, +41795616807; hursta@unitaid.who.int
UN Women: Maria Sanchez Aponte; +16467814507; maria.sanchez@unwomen.org
World Bank Group: Maya Brahmam; +1 202 361 2594; mbrahmam@worldbankgroup.org
WHO: Christian Lindmeier; +4179 500 6552; lindmeierch@who.int
Drug price cut will expand access to a key treatment for HIV coinfections
GENEVA – Unitaid welcomes the announcement by Gilead Sciences, Inc. that it will cut the price of the WHO-recommended drug AmBisome® to treat cryptococcal meningitis, an opportunistic infection that is responsible for 15 percent of the world’s HIV-related deaths.
This safer form of an older medicine, amphotericin B, will be available to 116 low- and middle-income countries at the new price of $16.25 per 50mg/vial. Unitaid collaborated on Gilead’s initiative to expand access to the drug.
“Gilead’s announcement is a critical step forward in reducing deaths among people living with HIV in less affluent countries,” Unitaid Deputy Executive Director Philippe Duneton said. “Unitaid will continue to work with manufacturers and partners to make sure these treatments are affordable and available to people living with HIV in countries most in need.”
In March, WHO recommended AmBisome® as part of a new, shorter regimen for cryptococcal meningitis, citing the regimen’s success in reducing deaths. Cryptococcal meningitis kills 181,000 people with HIV every year. Access to treatment for the infection is low, and the best regimens are not available.
People living with HIV face life-threatening opportunistic infections such as tuberculosis and meningitis because they are not on antiretroviral therapy, their treatment is inadequate, or their treatment has been interrupted.
In 2017, 940,000 people died of HIV-related illnesses. Following WHO guidelines on advanced HIV disease, Unitaid is working with pharmaceutical and diagnostics companies to increase access to the best tests, treatments and prophylaxis to prevent deaths from HIV coinfections.
Market and technology landscape: HIV rapid diagnostic tests for self-testing, 4th edition
The Hummingbird. Unitaid News – July 2018.
HIV self-testing market gathers pace, Unitaid report says
Geneva – To meet the UNAIDS target–that 90 percent of people living with HIV know their status by 2020–we must move beyond conventional testing and invest in strategies such as self-testing.
The fourth edition of the Unitaid-WHO market and technology landscape for HIV self-testing, published today, shows more and more countries introducing self-testing, and more self-testing products becoming available. Countries with HIV self-testing policies numbered 59 in 2018, up from six in 2015, and 28 countries were implementing self-testing in 2018, almost doubling from 2017.
Self-test kits are showing special potential for reaching into groups where HIV risk is high, but HIV testing has been low. Self-testing can be done in private, requires no special training, and serves as a entry point to HIV care and prevention.
An estimated 9.4 million people remained undiagnosed globally in 2017, many of whom belong to groups at high risk of contracting HIV, such as female sex workers, prisoners and men who have sex with men, as well as partners of people with HIV and young people in southern Africa.
“The HIV self-testing market has continued to grow and is poised to expand further,” said Unitaid Executive Director Lelio Marmora. “HIV self-testing is an important strategy in reaching underserved populations, and this report shows our investments, and those of our partners, have catalyzed the progress in this direction.”
A highlight of this year’s report is the comprehensive HIV self-testing market forecast.
The forecast projects that 16.4 million HIV self-tests will be procured globally in 2020, a significant increase from just one million self-tests in 2017. The report also estimates that public sector procurement will contribute 9.1 million self-tests in 2020.
The forecast shows growth in both public and private sectors. Beyond 2019, these increases are expected to be largely driven by low-, middle- and upper-middle-income countries implementing and scaling up HIV self-testing.
The report also presents an overview of self-testing products, including eight that are eligible for donor procurement, and one that has been prequalified by the World Health Organization (WHO). At least six other products that are in development are described. The diverse range of products and suppliers is encouraging. However, prequalification of additional products by WHO is needed to support the expected market growth. WHO prequalification is an internationally recognised assurance of quality for medicines and other health products.
Although the market outlook for HIV self-testing is good, the report recommends six priority areas for action by all stakeholders, including raising awareness of self-testing, and increasing demand for it.
- Download the full report here.
“MTV SHUGA” launches three new campaigns in South Africa and Côte d’Ivoire, focusing on HIV prevention and self-testing
Amsterdam – Unitaid, the MTV Staying Alive Foundation (MTV SAF) and the London School of Hygiene & Tropical Medicine today announced a three-year partnership to introduce storylines on HIV innovation, including HIV self-testing and preventive drugs (PrEP) into the award-winning drama series MTV Shuga. The programme is designed to help millions of young viewers in French- and English-speaking Africa protect themselves from HIV.
The effort, unveiled during the 22nd International AIDS Conference, will span Southern Africa and Western francophone Africa and deliver three new TV series of MTV Shuga, together with a multi-media campaign that promotes sexual health. The enhanced programme will target hard-to-reach populations, particularly people 15 to 24 years old.
The new MTV Shuga campaigns will be deployed in South Africa and Côte d’Ivoire between 2018 and 2020. Preliminary work for both countries begins this year, with the first television series due to broadcast in the first half of 2019 in South Africa, followed by two seasons in Côte d’Ivoire.
MTV Shuga fuses hard-hitting storylines with sexual health messages to influence viewers’ attitudes and behaviour. The “edutainment” campaign also features: a radio drama that expands on MTV Shuga storylines; print, digital and social media activity; and peer education programmes that challenge stigma and obstacles to young people’s sexual health.
The campaign—centered on HIV prevention and testing, preventive drugs known as pre-exposure prophylaxis (PrEP), HIV self-testing, and HIV treatment— aims to show young people how to protect themselves from the virus, and to seek out treatment.
AIDS remains the leading cause of death among 10- to 24-year-olds in Africa, bolstering the case for innovations and investments that place a high priority on this age group. Through the MTV Shuga campaign, Unitaid and MTV SAF will shine a spotlight on young people’s real-life concerns.
The campaign in francophone Côte d’Ivoire represents a commitment to the region, following years of focus on English-speaking countries in sub-Saharan Africa.
MTV Shuga is produced by MTV SAF and supported by Unitaid, a Geneva-based organization that funds promising innovations, such as HIV self-testing, that have the potential to make fast, sweeping improvements in global health. The success of MTV Shuga in influencing the attitudes and behaviour of viewers will be evaluated by the London School of Hygiene & Tropical Medicine.
Lelio Marmora, executive director of Unitaid, commented: “Millions of people in Africa watch MTV Shuga. Our partnership with MTV Staying Alive gives us a terrific opportunity to reach young people who don’t have reliable health information and empower them to take charge of their health — including testing themselves for HIV.”
Georgia Arnold, executive director of the MTV Staying Alive Foundation and executive producer of MTV Shuga stated: “The need to focus on the sexual health of young people is more important today than ever before. With the advent of developments like HIVST and PrEP, we have a unique opportunity to effect real change in young people’s lives. Continuing a multi-platform approach for MTV Shuga helps us keep reaching youth in every aspect of their lives and encourage an ongoing dialogue in the global fight against HIV.”
Professor Peter Piot, Director of the London School of Hygiene & Tropical Medicine added: “We are delighted to be working with the MTV Staying Alive Foundation by leading studies in South Africa and Cote d’Ivoire to evaluate MTV Shuga’s impact on increasing the demand and uptake of HIV self-testing and PrEP. With its broad reach and popular appeal across Africa, MTV Shuga has the potential to stimulate awareness of and demand for prevention and treatment services, particularly for young women and men, among whom HIV risk remains persistently high.”
