Injectable anti-HIV drugs could be available in 2017

By Esther Nakkazi

Science is moving HIV treatment and prevention forward from oral to injections. Instead of taking a daily pill for antiretroviral therapy it will switch to an injection lasting three months at most.

Scientists believe, especially women, who are also the most affected by HIV will easily adapt to the use of these long-lasting injectables because of their familiarity with injections through contraception.

Almost one in four new HIV infections in sub-Saharan Africa are in young people aged 15-24 years, and two-thirds of these are among girls who are also users of contraceptives and injectables are favourites.

“When you think about young women, in particular, being very adapted to getting injections for contraception this could be a very nice natural next step,” said Jeanne Marrazzo, the director of the University of Alabama at Birmingham School of Medicine Division of Infectious Diseases.

Scientists also believe the injectables will reduce stigma and daily adherence, which is still a challenge to people taking anti-HIV drugs daily and they will also give users a choice.

“Young people sometimes forget to take the pill so if we give them formulations where they do not have to worry it will probably work better,” Thomas Hope, a Professor of Cell and Molecular Biology at the Northwestern University, Evanston at the biennial HIV Research For Prevention conference (HIVR4P 2016) held 17-21 October in Chicago, USA.

The injectables under development will be used for therapy and for Post Exposure Prophylaxis (PrEP). Two different drugs, Rilpivirine by Janssen Pharmaceutical Companies of Johnson & Johnson and Cabotegravir by ViiV Healthcare, a global specialist HIV company with GSK, Pfizer Inc. and Shionogi Limited as shareholders are collaborating.

For treatment, two injections of Cabotegravir and Rilpivirine will be given in the butt at the same time. While for PrEP, only one injection of Cabotegravir - a new drug to users - will be administered.

“The treatment work is well advanced but prevention is still early,” said Joe Romano, President of NWJ Group, LLC.

Although treatment may be an easy sell to users it will be a challenge for PrEP which communities are less aware of.

“PrEP is more like a contraceptive. It is a product you give to healthy people. Overall, individuals are aware of pregnancy risk all the time and less about HIV risk, which comes on and off,” said Nelly R. Mugo, a gynaecologist and a principal research scientist at the Kenya Medical Research Institute (KEMRI).

But although injections for ARVs may be acceptable there are many technical issues yet to be addressed. Men are still naive in this field and most importantly how long can someone go between the injections, explained Romano.

Scientists are looking at injectables with drugs 3-4 millilitres and for it to last for 1-3 months.

“Men have no experience. Healthy men typically do not get an injection normally every three months,” said Romano.

Then variations in the human body around metabolism, drug absorption are also key as well as being cautious that when an injection goes in it cannot come out!

However, the most pressing issue for injectables for ARVs is the so-called ‘tail’, which basically means if the drug is injected in an individual at what point does its concentration go down so that they are not at risk before the next dose. If the drug levels are down what happens if infections with a bit of drug in the background?

“I think 3 months is good but if it starts to get less than that and you have to go every month to the clinic that is still a hustle,” said Lynn Morris the head of the HIV Virology laboratories at the National Institute for Communicable Diseases (NICD) in South Africa.

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Scientists caution public expectations on 2016 HIV cure breakthrough research

By Esther Nakkazi

In the year 2016, there was so much excitement about cure research opportunities from the ‘functional cure’ for HIV. However, scientists cautioned the public about high expectations.

Scientists at the National Institutes of Health (NIH) and Emory University in an experiment induced sustained remission of SIV in animals, which if translated to humans could mean that there is a possibility of having people on anti-HIV drugs sustain suppression of the virus and get off of the drugs. 

This is called sustained HIV remission or a ‘functional cure’ which is not a cure but an outcome of a treatment that induces prolonged, undetectable levels of HIV viremia without the daily anti retroviral treatment (ART).

I attended the biennial HIV Research For Prevention conference (HIVR4P 2016) held 17-21 October in Chicago, USA and Anthony Fauci, an immunologist who heads the U.S. National Institute of Allergy and Infectious Diseases (NIAID) and had carried out a landmark research about it explained that some people call it a cure others sustained remission.

Fauci with his team carried out an experiment, which involved infecting monkeys with SIV, the simian form of HIV. The research was published in the Oct. 14 issue of the journal Science.

According to a press release from the National Institutes of Health (NIH), the investigational treatment regimen consisted of 90 days of ART combined with 23 weeks of treatment with a laboratory-derived monkey antibody against a cellular receptor called alpha-4-beta-7 (a4b7) integrin. 

This antibody is similar to the human drug vedolizumab, which is approved by the U.S. Food and Drug Administration (FDA) for treating ulcerative colitis and Crohn’s disease.

The animals’ immune systems suppressed the virus to undetectable levels for as long as 23 months and the regimen led to the near-complete replenishment of key immune cells that SIV had destroyed, something unachievable with antiretroviral therapy (ART) alone.

Way Forward: 

While speaking to the press at the HIVR4P 2016, Fauci said there was so much that they (scientists) do not know, especially the mechanism, but what was loud and clear was the effect. So they decided to start a study in humans. 

The NIAID team will start an FDA approved study with 15-25 people with this profile; HIV infected, 18-65 years old, stable with controlled viremia, CD4 count of 450+, not pregnant and generally with a relatively healthy immune system.

They will get treatment interruptions of combined short-term vedolizumab treatment and ART for 30 weeks. Thereafter, both will be stopped and they will be followed for at least seven months.

The study investigators hope that what happened in the monkeys suppressing SIV replication will be repeated in humans - basically control the virus levels in the absence of ART and the antibody - so the immune system controls the virus in the absence of ART. Preliminary results are expected by the end of 2017 or beginning 2018.

“If we discontinue therapy in the 15 and 4 of them do not rebound that is the best anybody has ever seen,” said Fauci. Most patients immediately rebound after discontinuing therapy.

He also cautioned on public expectations. “Even if it is dramatic in animals we do not want to take a human who is infected and do more harm than good that is why we are starting off with a small phase I study whose primary goal is safety.”

African scientists comments about the 'functional cure' research; 

I interviewed some leading African scientists who attended the HIVR4P 2016 about the 'functional cure' research. Here is what some of said about it.   

'Cautious hopeful'. “It is exciting that we are beginning to get signals. However, these are monkey studies but bring hope. Over the years, we have learnt that people and animals are different so I would say -cautious hopeful, said Nelly R. Mugo, a gynaecologist and a principal research scientist at the Kenya Medical Research Institute (KEMRI).

'Surprising result.' “It is a very surprising result and I think everybody recognises that. I can say we do not really know how it is working, obviously we have some idea but we do not really know the mechanism,” said Lynn Morris the head of the HIV Virology laboratories at the National Institute for Communicable Diseases (NICD) in South Africa.

'It is too early.' “It is exciting because it offers another opportunity. If it is confirmed by other studies it will be quite exciting because people might be able to come off ART. But I think It is very early,” said Thumbi Ndung’u an immunologist and Scientific Director of the HIV Pathogenesis Programme at the University of KwaZulu Natal in South Africa.

Studies in Africa

Many HIV studies are done in Africa and Morris hopes that if a study is done in the US as Fauci promised there will be interest in doing it in South Africa.

In her opinion, from a cure perspective it is going to be a simple study do to. "The point is it is a licensed product so let us not waste time figuring out the mechanism let us just try it. If it works we can figure out if it really prevents rebounding then we can try and figure out how we can do this,” said Morris.

“It is exciting because integrins unlike the virus are the same. The big issue is going to be cost,” said Morris referring to monoclonal antibody therapies which are extremely expensive.

“But cost should never ever be used as a barrier to doing things because if there is a need the cost is a flexible controlled by demand. People should not come with negative things like cost I think the studies have got to be done and if they work people will find a way around the obstacle,” she said.

If the drugs work they will be re-licensed for HIV and it is envisaged that there will be a different pricing structure and there will be mass production. 

Over 37 million people according to UNAIDS need ART. Currently, they are only produced for the niche market for people suffering from inflammatory bowel disease. 

“It is yet another piece of evidence that we are moving closer to a situation where HIV is like cancer where it can be treated and does not come back in a long time,” Thumbi Ndung’u said.

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Ban on sex education in Uganda schools to be lifted

By Esther Nakkazi

By early next year, the ban on sexuality education in Uganda schools will be lifted after a policy to guide the curriculum on what will be taught has been developed.

We all had concerns that the sex education ban was unjustified but recently we talked about it at a Science Café and shockingly authorities in the know said it was a blessing in disguise.

The Science Café was the 14th held by the Health Journalists Network in Uganda at their home in Ntinda and the second one sponsored by United Nations Population Fund (UNFPA) Uganda Its theme was ‘teenage pregnancy’ held on November 30th with oversight from Reach A Hand.

Penninah Kyoyagala Tomusange the national programme officer, Adolescent and youth sexual and Reproductive Health and Rights at UNFPA-Uganda said although we all thought that the ban on sexuality education was a bad thing it was actually a good move by the government. Why?

Apparently, the previous content and packaging was terrible. So right now all stakeholders are meeting to create a package that will have relevant and accurate information for sex education in Ugandan schools.

“Sexuality education is about accurate information,” emphasised Kyoyagala. “No teenager wants to be a dad or Mum.”

Sexuality education is also a life long thing since environments keep changing, sometimes its verbal other times non verbal.

One misinformation that was in the old package was on condom use. So the new curriculum talks about proper condom use but condoms will not be distributed in schools. The students will be informed on where to find them in health facilities.

This is a good move but will it work given the disconnect between health facilities and education centres. The two government entities do not seem to speak to each other at all! Look at the way youth are always begging for youth friendly services in health facilities.

It is only a song well sang but only practiced by a few facilities like the Naguru Teenage Information Health Centre.

We also had Denis Lewis Bukenya the deputy director, Naguru Teenage Information and Health Centre (NTIHC) talk to us at the science Café. He too emphasised the need for accurate information and to regularly sensitize and empower teenagers to make better-informed decisions.

“Provide accurate information so that the decisions teenagers make are accurate,” said Bukenya.

He said the youth need to have ready access to youth friendly sexuality education services so they can get their needs and questions attended to. Bukenya also stressed a need to educate boys who are not only active participants in creating teen pregnancies but are also custodians of the decision making process.

Godfrey Walakira the training and development manager, Straight talk foundation Uganda, was also a speaker at the science cafés and gave astounding statistics. He said research shows 43% of all Uganda teenagers are forced into the first sexual encounter. The early sex debut is also at the young age of 12/13 years in Uganda.

Pregnancy usually leaves stigma around the girl yet many times it is not their fault entirely. Many are defiled and according to the Police crime report 2011, defilement was the most prevalent crime.

Meanwhile, teenage pregnancy is still a big problem in Uganda. Walakira noted that the national average prevalence of teenage pregnancy currently stands at 24% according to the Uganda Demographic Health Survey (UDHS 2011).

Regionally, the rate of teenage pregnancy is highest at 30.6% for Central Uganda, 30.3% for Eastern, 29.7% for Karamoja, 26.4% for West Nile and 25.6% for the North Uganda, Western Uganda is at 22.6 while south western is at 15%.

Walakira stressed the need to handle a number of issues that lead to teenage pregnancies including child marriages whose prevalence stands at 59% for Northern Uganda, 58% for Western region, 52% for Eastern region, 50% West Nile, 41.9% for central region, 37% for southWestern and 21% for Kampala according to the 2011 UDHS.

One way that Uganda can reverse these stats is increase in teenagers’ access to age appropriate sexual reproductive health information, which, can effectively be done through provision of appropriate information to the schools or directly through the communities.

The conclusion therefore at the Science Café was that Uganda should popularise sexuality education in schools. It will delay their sexual debut, probably reduce teen pregnancy but most importantly when the teenagers get accurate sex information they are empowered.

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Dissemination of new innovations for utilisation of Roots, Tubers and Bananas

By Esther Nakkazi

After three years of intensive research, the RTB-ENDURE project will present research findings on expanding the utilisation of Roots, Tubers and Bananas (RTB) in a workshop on Tuesday 6th and Wednesday 7th December 2016 at Crane Hall, Imperial Golf View Hotel, Entebbe.

An exhibition of RTB Technologies and Innovations will also be held alongside the workshop at the Botanical Gardens, which are located close to the hotel.

The project from 2014 to 2016 has added value to the fresh products of roots, tubers, and bananas, expanded their utilisation and reduced on their post-harvest losses among communities in the East African region, said Diego Naziri, a Post-harvest Specialist at International Potato Center (CIP).

Uganda has hosted the $4 million European Union (EU) funded project.

Realising RTB’s full potential as crops and as products in Africa is important as they are food security crops, important sources of income, are less susceptible to price fluctuations in the world food market as compared to grains and legumes.

CGIAR Research Program on Roots, Tubers and Bananas data entails that these are consumed as a staple food and they contribute over 20 percent of caloric requirements and constitute nearly two-thirds of per-capita food production in sub-Saharan Africa.

CGAIR-RTB project also confirms that Post-harvest losses are much higher with this group of crops than with grains, as inherent bulkiness and perishability have traditionally limited them to on-farm and local markets.

However, they are bulky, perishable, with a limiting shelf life and short direct marketing. Africa lacks handling and storage technologies of RTBs and with an underdeveloped potential for value addition.

Naziri says the RTB-ENDURE project has been a research-for-development that has placed research in the context of value chains and the demands and needs of its actors in the production, postharvest handling, processing, marketing, and business organization to make the chain function more efficiently.”

For more about the new innovations on this RTB-ENDURE project please follow #RTB on twitter and more will be highlighted on this blog. 

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Mombasa Tea Auction to go Digital

By Esther Nakkazi

After years of refusing to go digital, East Africa tea traders and growers have accepted to replace the current manual open outcry system, with the computerized electronic auction.

Today, East Africa Tea Trade Association (EATTA) signed a financing agreement with TradeMark East Africa (TMEA) to provide financing provide of US$ 1.5 million that will enable automation of the tea auction in Mombasa.

A statement from TMEA says the automation is expected to reduce the tea trading cycle by about 65% from the current 45 - 60 days to less than one month. Reduced delays will also ensure that farmers receive timely payments negating need to take loans to finance their producer operations.

The Mombasa tea auction is the world’s largest black tea auction and handles about 75% of tea exported through the port of Mombasa covering shipments from the EATTA member countries of Burundi, Kenya, Rwanda, Uganda, DRC, Tanzania, Ethiopia, Malawi, Madagascar and Mozambique.

In 2015, the auction handled more than 350 million kilos of tea, providing a platform through which more than one million farmers in Africa could sell their tea, before shipping it across the world.

The proposed integrated Tea Trading System (iTTS) will encompass the entire tea export processes including pre-auction, auction, post-auction and a Business to Business marketing network says a statement from TMEA.

“This portal will simplify the tea auction with the added benefit of increasing transparency and thus gaining stakeholder confidence in the auction,” said Mr. Nicholas Munyi, EATTA chairperson, at the signing ceremony.

“TMEA is committed to boosting intra- Africa trade and also East Africa’s trade with the world by reducing the barriers to trade. Automation of key trade systems is one way that has enabled us move closer to achieving this vision,” said Frank Matsaert TMEA CEO.

“I am excited to see that tea, a major forex earner for the region, will reach the breakfast tables across the world in an efficient and cost effective way and that the farmers working hard on their farms will regain confidence in the trading process as a result of the transparency and accountability the system will give,” explained Matsaert.

Once fully implemented, the platform, will ensure that, stakeholders of the tea auction including farmers, buyers and sellers, receive real time information on what is happening on the auction bourse.

Further, the automation will reduce delays and paper work, which is synonymous with the manual systems. The tea brokers will benefit from an automated and streamlined trading platform that reduces complex and bureaucratic trading processes and physical movement of documents to various players.

The tea producers both in Kenya and other countries in the region will have real time access to information on the tea sales as well as have lower logistics costs as they will be able to access the information online eliminating the need for travel to Mombasa.

Automation for the Mombsa auction was supposed to be implemented by 2013 using the Indian tea e-auction model, the only country in the world using it. A team from EATTA left for India on a fact-finding mission but found that despite it operating for eight years, the Indians still preferred the manual open outcry system.

The report presented by the team to EATTA said the Indian government imposed the e-auction on them in order to collect more taxes from tea but they were unhappy with it because it was not interactive and it was too commercialized without meeting in the auction room.

So EATTA stakeholders, overwhelmingly, voted against it in a meeting saying the auction, which basically, is a ‘public sales’, would lose its transparency, competition and risk technology failure without a guaranteed power supply at Mombasa.

The traders and growers said using the e-auction would be a health hazard if buyers were to sit uninterrupted through the 8 hours looking at computer screens and the auction would lose its gusto.

It is interesting that these now don’t see it as a health hazard and are willing to move with the times embracing technology.