HIV Pre-exposure Prophylaxis Access in Nigeria: The feasibility is real

HIV Pre-exposure Prophylaxis Access in Nigeria: The feasibility is real

HIV
By Morenike Oluwatoyin Folayan
Prescription of HIV pre-exposure prophylaxis (PrEP) by medical doctors in Nigeria is now possible with the registration of Truvada for use as a PrEP. ‘The registration was completed in January 2018 by Gilead representative in Nigeria,’ says Dr Chukwuma Anyaike of the Federal Ministry of Health, Abuja, Nigeria.HIV pre-exposure prophylaxis is the use of antiretroviral to prevent HIV infection in persons who are HIV negative but have substantial risk for HIV infection. The national guidelines on the use of antiretroviral in Nigeria promotes the use of tenofovir based antiretroviral drugs for use as PrEP.

The effectiveness of PrEP for the prevention of HIV infection in both men and women is globally recognized. It is able to prevent infection in persons who are HIV negative who use tenofovir-based antiretrovirals regularly and consistently. The most often prescribed tenofovir-based PrEP regimen is Truvada.

There are however gender differences in the tolerance of abuse of use of PrEP: PrEP is more forgiving in men whose risk of HIV infection is through the rectum as opposed to women whose risk of HIV infection is through the vagina. Research evidence show that for the same regimen, PrEP concentrations are lower in the vagina (compared to the rectum), meaning that high adherence to daily PrEP may be especially important for women exposed to HIV through vaginal sex.

Also, the use of PrEP by HIV negative women at substantial risk of HIV infection, during and immediately after pregnancy helps reduce the risk of HIV infection. Research evidence shows clearly that the risk of women acquiring HIV infection during the peri-conception period is significantly increased. This is a period when condom use is necessarily reduced. PrEP use during pregnancy, post-delivery and during the breastfeeding period has been strongly advocated. PrEP use during this period is safe and does not increase the risk of HIV negative  losing their pregnancy loss, having preterm birth, having babies with birth defects or congenital anomalies, or their babies having growth problems.

There is increasing concerns about why PrEP has not been rolled out in Nigeria. Nigeria has the second highest burden of HIV in the world. The concluded PrEP demonstration project conducted in Nigeria under the aegis of the National Agency for the Control of AIDS should have results to show how best to roll out PrEP in Nigeria. There are plans to share the results of the study during a satellite holding on the 14th of November 2018 at the 2018 CSO Accountability Forum.

There is also an ongoing demonstration study on the use of PrEP by men most at risk for HIV infection. The study is being implemented by the TRUST study being led by Population Council in Nigeria.

Many doctors have also been reached out to for the prescription of PrEP by persons who consider themselves at risk for HIV. The Infectious diseases Group at the University of Ibadan organized a one day session with medical doctors to provide updates on HIV management in collaboration with New HIV Vaccine and Microbicide Advocacy Society on the 1st of August 2018. Doctors present at the meeting were educated on the role as PrEP prescribers, and the care needs of persons on PrEP. In the absence of a national roadmap on how persons at substantial risk can access PrEP in Nigeria, the doctors may have to take a lead in this respect.

Dr Chukwuma Anyaike, a fearless advocate for and supporter for PrEP access in Nigeria working at the Federal Ministry of Health, feels Nigeria advocates need to be more vocal and active demanding for the roll out of PrEP. The Federal Ministry of Health has done all it should to create the supportive environment to make PrEP implementation possible. Health institutions and organization now need to take the bull by the horn and train their staff on how to facilitate PrEP access in their institutions.

For now, PrEP access is most likely going to be prescription-based. Sadly, this has large implications for access by those most vulnerable to HIV infection. The out-of-pocket expense for health in Nigeria is huge. Adolescents and young persons who are at high risk for HIV infection – those in early marriages, those with multiple sex partners, those in high HIV risk profession like sex work – are less likely to be able to access the much needed PrEP. Currently, HIV prevalence is on the increase only in the adolescent population in Nigeria.

Sadly, we can no longer wait and see. The reduced donor funding for HIV infection is starting to have its backlash – new HIV infection are being recorded in many centres in Nigeria. The government is not effectively stepping up to play its role with HIV management. There is no strategic plan to address the gaps created by donor fund withdrawal.

PrEP access is feasible in Nigeria but a lot more has to be done to make this a reality.

 

Programme at the HIVR4P conference

Programme at the HIVR4P conference

Dear participants at the HIVR4P 2018 in Madrid, Spain.
Please note the following opportunities for the advocates and early-career investigators.
Daily Meet the Experts Lunches provide early-career investigators and community advocates with valuable opportunities for informal, in-depth exchange with experts representing a cross-section of research issues, implementation challenges, and HIV-affected communities. Meet the Experts Lunches will be held on Tuesday, Wednesday, and Thursday in the Toulouse and Lyon rooms from 12:00 – 13:00. Approximately 20 experts will be available during each lunch session. Click here to view a list of the participating experts.

Space is limited and is available on a first-come, first-served basis.

In addition, please join AVAC, NHVMAS and IRMA for the “Advocates’ Pre-Conference Workshop” on Sunday, 21 October, 08:30 – 13:00. Specially designed for advocates, scholarship recipients, new investigators, first time attendees, community liaison officers and other stakeholders. All are welcome!

The half-day pre-conference workshop will provide an of-the-moment overview of the field and amplify hot topics to contextualize the themes and issues that will be presented throughout HIVR4P 2018. This year features a session on PrEP advocacy and implementation throughout Eastern and Western Europe with a special emphasis on Spain. Additionally, participants will engage in a lively conversation on priorities regarding the future of HIV prevention research, including advocacy strategies for ensuring a robust pipeline. An agenda will be circulated closer to date.

Please RSVP TODAY to hold your spot!!! tinyurl.com/r4padvocates **Limited seats available. Please register by Wednesday, 17 October.**

DATE: Sunday, 21 October
TIME: 08:30 – 13:00
LOCATION: Madrid Marriott Auditorium Hotel, the Dresden and Stuttgart room

Should you have questions, please contact secretariat@hivr4p.org.

Genius Grant’ Recipient Gregg Gonsalves Fights For Justice In Health Care : Goats and Soda : NPR

Genius Grant’ Recipient Gregg Gonsalves Fights For Justice In Health Care : Goats and Soda : NPR

A Global Health Evangelist Is Shocked To Hear He’s A ‘Genius’

Gregg Gonsalves, a global health advocate, is one of this year’s MacArthur “genius grant” winners.

Stan Godlewski/John D. and Catherine T. MacArthur Foundation

Gregg Gonsalves took a wild, meandering path to the Ivory Tower. His route to becoming a professor at Yale started in street protests and spanned the globe.

On Thursday he was honored with a prestigious MacArthur Fellowship.

Gonsalves is one of this year’s MacArthur “geniuses.” The award from the John D. and Catherine T. MacArthur Foundation comes with a $625,000 no-strings-attached stipend.

Gonsalves says he was shocked to learn that he’s getting this award. “I had no idea that anybody was scrutinizing what I’ve been up to lately,” the 54-year-old says with a laugh.

This national honor for creativity may redeem him with his parents, who were disappointed when he dropped out of college in the mid-1980s and drifted around waiting tables.

“That was about the time I was coming out of the closet and realizing I was gay,” says Gonsalves, who grew up in a conservative family of Portuguese and Italian Catholics.

“Then I met somebody who was HIV positive and that changed my life. There were no treatments for the disease then, and it was terribly scary to think about what the future was for both of us.”

That moment that set him on a path for which he’s now being feted as one of the nation’s leading thinkers on global health and social justice. Back in the ’80s he just wanted to understand HIV and found there was very little information about the disease.

“This was before the Internet,” he says. “And if you wanted information on medical things you had to sneak into medical libraries or ask medical students.”

He ended up joining the legendary activist group ACT UP (AIDS Coalition to Unleash Power) in the late 1980’s and moved to New York as the epidemic was exploding.

“I got swept up in this movement,” he says. “I joined the treatment data committee of ACT UP New York and was working on science policy and clinical research and trial design and basic immunology. I was teaching myself all these sort of things that I never sort of bothered to study in school.”

Amid street protests and handcuffing himself to the gates of drug companies, Gonsalves was trying to reform how HIV research was conducted at the nation’s top research institutions. They were pushing for better treatments and a broader understanding of the disease.

In 1992, still without a college degree, he co-founded the Treatment Action Group or TAG.

“One of the first advocacy projects that Gregg and I did was a review of the entire National Institutes of Health AIDS research portfolio,” says TAG co-founder Mark Harrington.“And we made some sweeping recommendations to reform it and to create a stronger office of AIDS research that would have the power to create a research agenda.”

Their review led to significant reforms at NIH.

But NIH wasn’t the sole barrier to getting treatment for people with AIDS. The disease was far more than a medical condition. AIDS was political and it was polarizing. The Reverend Jerry Falwell called the virus “God’s punishment for homosexuals.” People with the disease were written off as “whores, fags and junkies,” Gonsalves says describing how critics dismissed the victims and downplayed the importance of the epidemic.

“You know in a weird way the HIV epidemic was an X-ray on to the pathologies of American society and global society as well,” Gonsalves says. “There was a lot of debate about who lives and who dies, who had social worth and who didn’t.”

He says the epidemic shaped his views on global health.

“AIDS was a wake-up call for me,” he says. “It wasn’t just a virus. The epidemic was man-made. It was created by inaction, sluggish responses from the federal government. And all you have to do is to move ahead in time to 2018 and you can see it all happening again. Whether it’s with Ebola or other infectious diseases like cholera in Haiti, we see these outbreaks of infectious diseases that again are man-made. Infectious disease will always be with us but epidemics are a human creation.”

What he’s saying is that the problem is not just the disease, it’s how people respond or don’t respond to these outbreaks. He’s taken a similar social justice-centered approach to other problems.

While working in a South African township in 2015 he analyzed the correlation between the distance women had to walk to get to an outdoor toilet and rates of sexual assault.

“The city of Cape Town was saying they can’t afford to upgrade sanitation in [the township of] Khayelitsha,” he says of the study. City officials, he says, argued, “It’s too expensive. We can’t do it.”

Gonsalves ran mathematical models analyzing assault rates and the cost of sanitation upgrades. Installing more toilets, he found, would save money.

“It made sense to increase the number of toilets in Khayelitsha both to reduce sexual assaults, but it also financially would save the city money on the downstream effects of sexual assault that they didn’t think they were paying for. But they were paying for medical care, increased policing, people being out of work, families being out of work, all because of sexual violence.”

Nicoli Nattrass, an economist at the University of Cape Town who worked with Gonsalves in the late 2000s in South Africa. says one of his greatest assets as an activist is his calm demeanor.

She remembers in 2008 when they were trying to convince a panel of experts at the World Bank that it was worth funding an effort to increase the number of HIV-positive people on anti-retroviral treatment — and that would slow the epidemic.

“He had those personal skills I often lack,” Nattrass says, “which allows him to talk rationally and very convincingly to people even when they’re being rude and hostile.”

The concept of “treatment as prevention” that Nattrass and Gonsalves were pitching more than a decade ago is now widely accepted as one of the most important strategies against the global HIV pandemic.

It wasn’t until Gonsalves was in his 40s that he finally decided to go to college. He applied to Yale and has been there ever since. He’s now an assistant professor of epidemiology.

In 2012 he co-founded the Global Health Justice Partnership, which is a project hosted by both Yale’s law school and its school of public health.

Lately he’s been looking at the link between the war on drugs in Brazil and that country’s tuberculosis problem. Brazil is ranked by the World Health Organization as having one of the highest TB burdens in the world, and the problem is particularly bad among prisoners. Another recent paper he worked on considers what factors caused an HIV outbreak among opioid users in Indiana to be as bad as it was. The paper shows that if more medical services for drug users had been available, the outbreak potentially could have been dramatically smaller.

“A lot of my work is about how you get services to people who need them — and these are often marginalized and poor people,” he says.

And these people could be anywhere in the world. To Gonsalves global health is about social justice. It’s become a proxy for who gets access to resources, who gets sick and who doesn’t, who lives and who dies.

He holds no punches in saying how he feels about nationalist movements globally including the America First ideology of President Trump.

“The entire world is moving toward a much more brutish cruel corrupt system. And you know nobody’s health is going to fare well in that system because health care is way down the list of what oligarchs care about.”

The MacArthur Foundation in naming Gonsalves as one of this year’s fellow says he might just be part of a movement to counteract the global inequities in health. In a statement announcing the awards, the Foundation praised Gonsalves’ current role at Yale.

“Gonsalves is training a new generation of researchers who, like himself, work across public health and human rights sectors, scholarly research and activism to correct disparities in global public health,” the Foundation said.

Gonsalves says correcting those disparities is important whether political leaders realize it or not.

“We can’t wall ourselves off in these gated communities,” he says, “and think what happens in the rest of world doesn’t matter.”




==========
Kay Marshall

+1 347 249 6375
kaymarshall@mac.com
skype: ninakaymarshall
IRMA’s new report on NIH prevention research priorities + info on the very hot, related webinar Monday 1 October

IRMA’s new report on NIH prevention research priorities + info on the very hot, related webinar Monday 1 October

Remember last year when the NIH was soliciting input on HIV prevention research priorities from scientists, advocates, and other stakeholders?

Remember how NIH asked all of us, time and again, to please share our expertise and give them our thoughts and ideas about the future of HIV prevention research?

Remember that?

Remember how MANY MANY MANY of us took them up on their offer?

And do you remember how NIH came out in January of 2018 and said, basically – no more microbicide research?

Remember when they said that they were only interested in drugs/formulations that were systemic and long acting, and that microbicides that were not systemic and long-acting would no longer be funded?

FINAL QUESTION – Do you think the input they received led NIH to the above decision – to no longer support products that were short acting, non-systemic, and on-demand?

SPOILER ALERT – the input they received (over 300 pages worth) – does not support their current direction. Not. One. Bit.

And we’re NOT having it.

I suggest: read the report, join the webinar, and GET BUSY.

Read the IRMA report – “Whose Choice is it Anyway? Analysis of Comments to and Responses from NIH’s 2017 Refining the Research Enterprise Request for Input on Research Priorities” right here (and share it via this url — tinyurl.com/whosechoiceanyway 

Jim Pickett

Senior Director of Prevention Advocacy and
Gay Men’s Health, IRMA Chair
AIDS Foundation of Chicago | 200 West Jackson Blvd., Suite 2100 | Chicago, IL 60606
Mobile: 773-600-6407| Main: 312-922-2322 | Skype: jimpickett66

Can the role of Africa Vaccine Manufacturers Initiative include coordination of the HIV Vaccine research and development enterprise in Africa?

Can the role of Africa Vaccine Manufacturers Initiative include coordination of the HIV Vaccine research and development enterprise in Africa?

Can the role of Africa Vaccine Manufacturers Initiative include coordination of the HIV Vaccine research and development enterprise in Africa?

By Morenike Oluwatoyin Folayan

At the just concluded Africa Vaccine Manufacturers Initiative (AVMI) meeting held at the Radisson Hotel at Freetown, Sierra Leone on the 24th and 25th of September, 2018, the suggestion for AVMI to coordinate the HIV vaccine research and development enterprise on the continent was muted. The role of a HIV vaccine used in combination with other effective HIV prevention tools in controlling the global HIV epidemic was highlighted, the ongoing HIV vaccine research efforts in Africa was identified, and the gap in continental-initiated HIV vaccine clinical trials noted.

There are diverse perspectives about this. Simon Agwale, the CEO of the Innovative Biotech had a distinct model of vaccine research, development and manufacturing. His organization shall support the research and development process. This will feed into the vaccine manufacturing pipeline of the company. He reported conducting basic research on Ebola vaccine and HIV vaccine development with successes with the development of candidate vaccines to move into clinical trials.

Simon feels strongly about AVMI playing a key role in coordinating HIV vaccine research and research development enterprise in Africa by developing an R&D coordinating entity in the AVMI secretariat. The R&D monitors research with potentials for the development of vaccines. The secretariat can then support the push of products into vaccine production pipeline.

Ebrahim Mohammed of Biovac, a company set up to manufacture vaccines located in South Africa, was also of the same opinion but for a different reason. He feels strongly the AVMI needs to monitor research and development of HIV vaccine and all other ongoing research on vaccine development for diseases of interest to Africa. However, the monitoring of activities in these spaces should be for the development of a healthy ecosystem for vaccine manufacturing and less so for the purpose of coordinating HIV vaccine R&D in Africa.

Unlike Ebrahim, Mwai Ngibuini, from Merck based in Kenya and a participant at the AVMI meeting, felt strongly that AVMI role should not include HIV vaccine R&D coordination as this is a different enterprise outside the sphere of work of AVMI. However, when a vaccine is finally discovered, AVMI role to support its manufacturing in Africa will then be critical. Right now, AVMI should not and cannot focus on HIV vaccine R&D coordination as its mandate does not include R&D.

Patrick Tippoo, the Executive Director of AVMI also shares the views and opinion of Mwai. He is of the opinion that HIV vaccine research is very risky with long timelines and it is not within the mandate of AVMI. Even if one takes an optimistic view about the likelihood of t developing a HIV vaccine, it does not seem like something that will be in the horizon in the next 10 years.

The AVMI should however look forward to engaging more actors and players in the field says Mwai. These include civil society representatives, country level policy makers and other end-users to prevent the organization talking to itself, he says.

Why critical action needs to be taken now to address future human vaccine access challenge in Africa

Why critical action needs to be taken now to address future human vaccine access challenge in Africa

Participants who attended the meeting in a group photograph
Participants who attended the meeting in a group photo

Critical action needs to be taken now to address future human vaccine access challenge in Africa -Africa Civil Society Actors in the HIV Field can help fill existing gaps

By Morenike Oluwatoyin Folayan, Everest Okeakpu, Bartholomew Ibeh, Chukwunonso Ikeotuonye

The Africa Vaccine Manufacturing Initiative (AVMI) held its annual meeting at the Radisson hotel, Freetown, Sierra Leone on the 24th and 25th of September, 2018. The meeting had over 40 persons from Africa, Europe, America in attendance. Discussants at the meeting noted that vaccine manufacturing in Africa is critical especially at this time that more countries on the continent are graduating from GAVI. Nigeria recently asked for the extension of its graduation till 2028.

Sadly, there is no transition plan for countries who will graduate from GAVI on the continent that produces only 1% of its human vaccine needs. Vaccine manufacturing on the continent needs to be actively promoted. Actions to address the gap that will be created from Africa nations graduating from GAVI needs to be strategically planned now.Government action is critical for vaccine manufacturing. The process is capital intensive with limited potential for profit in the short term. Promoting public-private partnerships will be helpful. A lot more needs to be done on the continent to get the governments to do more than sign on to resolutions that promotes vaccine manufacture.

The Governments of Senegal, Ghana and Nigeria have been exemplary in this respect. The Senegalese government supports the continued production of yellow fever vaccine. The Ghanaian government in collaboration with Merck, Bosch and the German government are also working at developing a vaccine manufacturing plant in Ghana through the ASPIRx project, whilst the Nigerian government recently gave approval to a Joint Venture company, with the government, Biovaccines and May and Baker Pharmaceuticals PLC to reactivate vaccines manufacturing in the country.Sadly, Nigeria and South Africa had produced human vaccines – yellow fever, small pox – in the past. The poor focus on maintenance resulted in their failure to meet global standards for human vaccine production. There are continued concerns about the continent been able to produce quality vaccines. Participants were however certain about the competency to produce quality vaccine on the continent. However, we have to produce at a standard higher than that in the USA to regain public confidence, stated Simon Agwale the CEO of Innovative Biotech working towards the development of a HIV vaccine and the production of typhoid vaccines in Nigeria.

Government commitment to fund vaccine manufacturing is essential. This is a gap area which Civil Society working in the field of HIV can help. We do not need to start from the scratch noted Mrs Sybil Ossei-Agyeman-Yeboah, of the West Africa Health Organisation. We can harness the milestone the civil society working in the field of HIV had gained to fast-track advocacy for government support for vaccine manufacturing in Africa she expressed.

AVMI should serve and is poised to serve as the regional platform for coordinating vaccine development and manufacturing efforts in Africa. They should be setting the agenda, prioritizing the development of low cost technologies for vaccine manufacturing, and should be funding and supporting advocacy for vaccine development and manufacturing on the continent.This does not preclude the role of the Regional Economic Communities from facilitating vaccine manufacturing. The role they have played in harmonizing regulatory processes as seen in East Africa and ongoing in West Africa is of significant importance for vaccine manufacture.

There is prospect and an already large and growing vaccine market in Africa. Available data shows that the high birthrate in Africa exceeds its capacity to vaccinate. This has so far obscured the spirited efforts at attaining full vaccination and eradication of child diseases. Also, there is no influenza manufacturing efforts going on on the continent nor are there preparatory efforts to prepare for an influenza outbreaks that will likely occur.

There are evidences to show that Africa has the competency to develop vaccines. Biovac is exporting vaccine technology while Institute Pasture in Senegal is producing yellow fever vaccine. What the continent needs is capacity enhancement and not capacity building. ‘However, there is a gap in civil society engagement in this field’ Morenike Folayan, the Coordinator of the New HIV Vaccine and Microbicide Advocacy Society identified. ‘Civil Society organisations like the Vaccine Advocacy Resource Group and the WACIHealth are poised to take this advocacy forward’ she noted.