Source – https://theconversation.com/

Women make up more than half of the people living with HIV around the world. Young women between the ages of 10 and 24 are twice as likely to get HIV as young men in the same age group. In East and Southern Africa young women will acquire HIV on average five to seven years earlier than their male peers.

Researchers have been working hard to find effective HIV prevention measures.

Most notable is the pre-exposure prophylaxis (PrEP) pill known as Truvada. This is a combination of two antiretroviral drugs – tenofovir and emtricitabine. This can be effective in preventing HIV acquisition. But taking a pill every day is not practical for many people.

Scientists from the HIV Prevention Trials Network recently found that a PrEP regimen of long-acting cabotegravir (CAB LA) injections once every eight weeks was better than the daily tablet used for HIV prevention. Ina Skosana spoke to Sinead Delany-Moretlwe, a research professor at the University of the Witwatersrand in South Africa and director of research at the Wits Reproductive Health & HIV Institute to find out more.

Can you tell us about the study?

This study, known as HPTN 084 is the first one to compare the efficacy of two HIV prevention or pre-exposure prophylaxis regimens.

The first regimen consisted of an injection of the long-acting antiretroviral drug, cabotegravir given every eight weeks. The second regimen was the daily oral dose of Truvada. Truvada has been shown to be highly effective for HIV prevention when taken as prescribed in a variety of populations and contexts.

We enrolled over 3,200 sexually active, HIV-uninfected cisgender women at 20 sites in seven countries. Research took place in Botswana, Eswatini, Kenya, Malawi, South Africa, Uganda, and Zimbabwe between November 2017 and November 2020.

Our study randomised participants to one of two arms. One arm received active cabotegravir and a Truvada placebo. The other arm received active Truvada and placebos for cabotegravir. Cabotegravir was administered daily by mouth for 5 weeks and via intramuscular injection at 8-weekly intervals after an initial 4-week interval load.

What did you find?

Preliminary findings show that overall 1% of participants were infected with HIV during the study period. This suggests that both cabotegravir and Truvada are highly effective for HIV prevention in this population.

The 34 incident infections detected in participants assigned to Truvada is equivalent to an incident of 1.79%. And the four infections detected in the participants assigned to cabotegravir is equivalent to an incidence of 0.21%. This confirms a new prevention option for women that offers a significant advantage over existing oral PrEP which requires consistent daily use and is associated with significant adherence challenges.

We observed roughly 9 times the number of incident HIV infections in the Truvada arm compared to the cabotegravir arm. This finding suggests that cabotegravir is much more effective than Truvada in preventing HIV infection in women. And the threshold for early stopping of the trial was met. Based on these findings the independent data and safety monitoring board recommended that the blinded portion of the study be stopped early and the results released to the scientific and broader community.

An earlier sibling study in cisgender men and transgender women called HPTN 083  showed similar results. A prep regimen containing long-acting cabotegravir injectable once every 8 weeks was superior to the daily oral Truvada in that population.

What are the next steps?

The study results are important and timely as more methods to prevent HIV among women at higher risk of HIV are urgently needed. These include methods that do not depend on daily or near-daily pill-taking, condom use or abstention from sex. The development of alternative methods to prevent HIV, and more adherence-friendly schedules than are currently available, will increase the HIV prevention choices and acceptability for women and reduce new HIV infections.

We have communicated with the research ethics committees and national drug regulators overseeing this study, and site investigators and study participants are being notified about the results as soon as possible. Participants will be able to learn about the medication that they were receiving. A protocol amendment will be submitted for regulatory review to allow participants to continue taking their assigned medication or to switch to cabotegravir if they choose.

Participants on Truvada will be offered cabotegravir as soon as the medication can be made available. All participants will be asked to continue on the study. And if they chose not to remain on the study, they will be referred for the best locally available HIV prevention services. We look forward to presenting these results in a peer-review setting at upcoming conferences as we finalise the primary analysis.

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Many African countries are struggling against the human immunodeficiency virus (HIV) infection, which results in contraction of the acquired immune deficiency syndrome (AIDS).

The disease, which damages human immune system, has left an estimated 74.9 million affected worldwide, according to figures collected by the Avert website, a U.K.-based charity providing information about HIV and sexual health. Currently an estimated 37.9 million people across the world are living with the HIV that includes 1.7 million children.

According to the website, 770,000 people died due to AIDS-related illnesses in 2018.

The numbers have reduced by 55%, if compared to deaths in 2004 (1.7 million) and in 2010 (1.4 million).

In Africa, according to a count taken in 2018, around one in every 25 adults is infected with the HIV/AIDS.

The continent hosts 25.7 million HIV/AIDS affected population, as per the World Health Organization (WHO).

As many as 16.3 million people have received antiretroviral therapy (ART) in 2018.

Eastern and Southern Africa regions inhabit world’s highest number of people infected with the HIV/AIDS.

Kenya, located in eastern Africa, like many African countries, is battling HIV/AIDS. Officials warn that although government is providing free drugs, patients are not serious about their medication.

According to UNAIDS, 1.6 million people were living with HIV in Kenya. While 89% of them knew their status, 68% were on treatment. As many as 270,000 of them were young men.

In Uganda, 1.4 million people were reported living with HIV/AIDS in 2018, according to UNAIDS.

While 23,000 people died from an AIDS-related illness in 2018, another 53,000 people had contracted the virus.

In Somalia, 11,000 adults and children were living with infection, while 1000 people died of the disease.

South Africa has the highest number of HIV cases in sub-Saharan Africa. Some 7.7 million people are living with the virus. The number of newly infected people has been put at 240,000 by the UNAIDS. In 2018, some 71,000 people died from the disease.

Southern and Eastern Africa is also infamous for hosting the greatest number of infected children.

According to the UNICEF, 1.85 million children aged 0–19 are living with HIV/AIDS in the region.

Out of them, 51,000 contracted infection after birth.

There are also 11 million AIDS-affected orphans in Sub-Saharan Africa.

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ADDIS ABABA, Oct. 30 (Xinhua) — China has been making direct and indirect contribution to Africa’s efforts in the fight against HIV/AIDS, tuberculosis, and malaria on the continent, an official of the African Union (AU) said.

Speaking to Xinhua exclusively on Wednesday, Benjamin Djoudalbaye, AU Acting Head of HIV/AIDS, TB, Malaria, noted that China’s contribution to the Global Fund, which is to fight against the major deadly diseases, is one of the indirect support areas in the fight against HIV/AIDS on the African continent.

The World Health Organizations (WHO) says HIV continues to be a major global public health issue. In 2018, some 770, 000 people died from HIV-related causes globally.

There were approximately 37.9 million people living with HIV at the end of 2018, with 1.7 million people becoming newly infected in 2018 globally. And 62 percent of adults and 52 percent of children living with HIV were receiving lifelong antiretroviral therapy (ART) in 2018.

Africa is the most affected region, with about 25.7 million people living with HIV in 2018; and the continent accounts for almost two thirds of the global total of new HIV infections, according to WHO.

Reiterating that Africa is one of the most affected regions by HIV/AIDS in the world, the AU Acting Head of HIV/AIDS, TB, Malaria said the continent has achieved remarkable results in the past two years, despite the success stories are with disparities.

“For the last couple of years, I think we are on the (trajectory) in controlling HIV today on the continent, ” the official said, adding people have access to treatments and efforts were made to reduce maternal mortality and mother to child transmission of HIV.

“The new infections are going down in parts of the continent but despite all these efforts the disparities exist,” he said.

In addition to the indirect contribution through the Global Fund, China forged a very good partnership with the 55-member pan-African bloc, whereby it provides supports, including among others training for experts who have indispensable role in the fight against the HIV/AIDS.

“For us, as the African Union, we have a very good collaboration with China. And recently two of my two members went to China and were trained on HIV control. So, this type of action programs do exist between China and the African Union Commission,” he said.

Reiterating that Africa has achieved remarkable results in the anti-HIV/AIDS interventions, the acting head mentioned Botswana and Rwanda as two success stories on the continent.

“I can tell you two success stories; a country like Botswana has virtually eliminated mother to child transmission of HIV; that is a success story; and the second success story is that a country like Rwanda will control HIV, as a program of Public Health, before 2030,” Djoudalbaye has noted.

Speaking of the challenges, Djoudalbaye says funding and resistance to the drug are among the two major challenges in Africa, while the health system is also there as far as the fight against HIV/AIDS is concerned.

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Two major U.S. biomedical research funders plan to each put at least $100 million over 4 years toward bringing cutting-edge, gene-based treatments to a part of the world that often struggles to provide access to even basic medicines: sub-Saharan Africa. The National Institutes of Health (NIH) and the Bill & Melinda Gates Foundation today announced the unusual collaboration to launch clinical trials for gene-based cures for HIV and sickle cell disease within the region in the coming decade.

The ambitious goal is to steer clear of expensive, logistically impractical strategies that require stem cell transplantation, and instead develop simpler, affordable ways of delivering genes or gene-editing drugs that can cure these diseases. “Yes, this is audacious,” NIH Director Francis Collins said during a press teleconference this morning on the project. “But if we don’t put our best minds, resources, and visions together right now, we would not live up to our mandate to bring the best science to those who are suffering.”

After decades of work and setbacks, the traditional gene therapy approach of delivering DNA into the body to replace a defective gene or boost a protein’s production is now reaching the clinic for several diseases, including inherited blindness, neuromuscular disease, and leukemia. Animal studies and some clinical trials have suggested that two diseases prevalent in Africa, HIV and sickle cell disease, can be treated by gene therapies or newer genome-editing tools such as CRISPR.

But in most cases, introducing those therapeutic genes or the components of a genome editor involves removing stem cells from the body, adding or modifying genes, then reinfusing the cells back into the body. That is essentially a stem cell transplant with one’s own cells, an expensive procedure that is also typically risky because physicians wipe out a patient’s existing stem cells with chemotherapy so the corrected cells can engraft and grow. It remains out of reach for most people in sub-Saharan Africa, where few places have the medical infrastructure to support such intensive interventions.

Yet sub-Saharan Africa is home to about two-thirds of the 20 million people with sickle cell disease and the 38 million living with HIV. The NIH-Gates partnership “is an incredible opportunity to find new therapies and possible cures for two diseases that affect millions of Africans and to make them available at affordable costs,” said Matshidiso Moeti, who heads the Regional Office for Africa at the World Health Organization.

Anthony Fauci, director of NIH’s National Institute of Allergy and Infectious Diseases, noted that if this collaboration pans out, it could also lead to enormous cost savings. “If we do successfully achieve an HIV cure, it will ultimately be important not only for millions of individuals with HIV, but also will save hundreds of billions of dollars in health care costs,” said Fauci, whose institute already funds a major HIV cure initiative.

In sickle cell disease, which involves a defect in the oxygen-carrying hemoglobin in red blood cells, several ongoing gene therapy and gene-editing clinical trials in the United States and Europe are either adding a new hemoglobin gene to cells or turning on the gene for a fetal form of the protein. Other clinical trials for HIV have used CRISPR or other genome editors in stem cells to cripple a receptor, CCR5, that the virus depends on to establish infection.

Instead of modifying a person’s stem cells and transplanting them back, the new collaboration will seek to ferry a therapeutic gene or gene-editing tools directly into the body (in vivo) with “vectors” such as harmless viruses or nanoparticles, Collins said. The treatment itself would be similar to a simple blood transfusion. Although studies are already underway with viral vectors that deliver new genes to certain tissues in people, in vivo gene therapy has only been used to modify blood stem cells in animal models of certain diseases. Figuring out how to home in on and modify those cells in people “is a big part” of the collaboration’s plan, Collins said.

Hematologist Alexis Thompson of the Northwestern University Feinberg School of Medicine in Chicago, Illinois, who is involved with some sickle cell gene therapy trials, calls the NIH-Gates collaboration “phenomenal.” But, she says, a more urgent need is to expand efforts to screen newborns in Africa for sickle cell disease and treat them with antibiotics; at the moment, the majority die before age 5 from bacterial infections because the sickled cells impair the spleen’s ability to filter bacteria and make antibodies. Unless more children with sickle cell disease mutations survive longer, there will be few to be cured with the new gene-based treatments, Thompson says. “It’s almost being able to crawl or walk before you sprint.” (Gates and NIH say they plan to support screening efforts outside of the new collaboration.)

For HIV, a big impetus for the cure push builds on two people infected with the AIDS virus who were cured with stem cell transplants. These two men each had blood cancers that required the transplants, which intentionally used blood from donors who had white blood cells with crippled CCR5 receptors. After the transplants, whatever HIV remained in these men could not enter new host cells, and their infections petered out. This new initiative hopes to speed development of direct injections of gene editor components that can target the CCR5 gene in blood cells and cripple it. “The potential beauty of in vivo gene editing is that it might be given ultimately as a single shot, curing everyone in a scalable manner,” says Steven Deeks, a leading HIV cure researcher at the University of California, San Francisco.

The collaboration will also try to speed development of more experimental interventions that directly excise HIV’s genetic material from a patient’s cells or allow people to artificially make superpotent antibodies against the virus. “This might be science fiction now, but one day may be a real possibility,” Deeks says.

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