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  US FDA approves unique 3-in-1 antiretroviral pill                                                                  13th July 2019
   
  The United States Food & Drug Administration has approved the first ever antiretroviral tablet to contain drugs made by two separate pharmaceutical companies.

ATRIPLA™ combines the drugs SUSTIVA® (efavirenz) made by Bristol-Myers Squibb and Truvada® (a combination of emtricitabine and tenofovir disoproxil fumarate) made by Gilead Sciences.  Taken together, these three drugs represent one of the most potent and popular antiretroviral regimens currently available in the US, and scientists hope that by cutting the pill burden to just one pill, taken once a day, it will greatly improve adherence and thus reduce levels of acquired drug resistance.

It has taken collaborating scientists from the two companies several attempts to arrive at a suitable formulation for their new tablet.  Their first tries at combining the drugs resulted in a product that melted into a sticky mess within a few hours.  However, eventually they hit upon the solution of keeping the two ingredients in separate layers to ensure stability.  

ATRIPLA™ will become available to patients in the US within 7 working days, although it could take far longer for it to reach HIV+ people in other parts of the world.  Price may also be an issue.  Combining the drugs has not reduced the cost, and the pill is expected to be sold for the sum of its two separate components ($1,150.88 for a 30-day supply).  When it is eventually marketed to poorer countries, it will probably cost around $800 per person per month, approximately four-times the price of the cheapest regimes currently available.

When combination antiretroviral therapy was first introduced 10 years ago, some people had to take up to 30 pills a day to control their HIV.  The new multi-vitamin sized one-a-day pill represents something of a revolution therefore.  "People were talking about once-a-day as a magical, wonderful, far-off moment,” said Craig E. Thompson of the Los Angeles AIDS project   “It was one of those things we were waiting for, and we've done a great job in getting there."
   
  AIDS orphanage inundated with donations                                                                                 11th July 2019
   
  An AIDS orphanage in Soweto, South Africa, has been inundated with public donations after thieves stole over R50,000 (£3,800) of goods from the centre.

Four armed robbers broke into the Ikageng Itereleng Aids Ministry Centre on the night of Sunday 2nd July.  The men took over 50 pairs of shoes destined for distribution to local children, several computers, two printers, a fax machine and a safe containing R1,500.  What they couldn’t steal they then smashed or broke, leaving the centre wondering how it could afford to care for the children in its charge.

After the South African newspaper, The Star, featured the story on the front page however, donations came pouring in from across South Africa.    

"The response from the public has been amazing," said Carol Dyantyi, founder of the centre, which offers financial and emotional support to children who have lost their parents to AIDS.

So far the centre has received over R40,000 in cash as well as large quantity of food, shoes, clothing and toys.  The printer manufacturer Kyocera Mita South Africa also donated three printers to replace those that had been stolen.
   
  Sex Workers in India join HIV testing reward scheme                                                                 10th July 2019
   
  Sex workers in the Southern Indian city of Mysore are to be given special discount "Smart Cards" as part of a new project to encourage sex workers to tackle HIV and AIDS.
The cards will be issued to local women working in the sex industry on the proviso that they attend a sexual health check-up every three months.  The cards can then be used to obtain discounts in local grocery stores, clothes shops and a few restaurants, and will also carry medical details of the owner. The scheme, which is the first of its kind, is being funded by the Bill and Melinda Gates foundation as a pilot project.  If successful, it could be extended across India. Sushena Reza-Paul, a representative of the Karnataka Health Promotion Trust who are running the scheme, said it had been warmly welcomed by local sex workers.  “They tell me that only rich people can normally have these kind of cards -- so it gives them a sense of pride and belonging," she said. "We are already getting calls from different places. Once the pilot project is completed, we will tabulate the findings and see how the scheme can be implemented." Opponents have however said the scheme could make sex work more appealing to women in the area who may see the cards as a 'perk' of the job.  Card owners also risk being singled out as prostitutes and discriminated against, which may result in few women actually using the card in practice. 5.7 million people are living with HIV in India, the largest population of HIV+ people in any country anywhere in the world.
   
  Criminal Transmission of HIV in the news again                                                                            4th July 2019
   
  The issue of criminalising the transmission of HIV has received significant attention in recent weeks.  First it was the case of Sarah Jane Porter, a UK woman who caused outrage among the tabloids after being found guilty of ‘recklessly’ transmitting HIV (see 'UK woman sent to jail for transmitting HIV').

Last Thursday, the Malaysian government announced it was amending laws so that anyone who donates blood when they know they have HIV can be imprisoned.

Then on Sunday, the Ugandan government announced that it was tabling a law that would impose a death sentence on anyone who knowingly transmitted HIV to someone under the age of eighteen.

Now, the Supreme Court in the US State of California has ruled that an individual can be sued for passing on HIV, even if they do not know they have the virus.

While all these decisions have evolved from different legal systems and different cultures, they all represent a growing trend towards the identification of people who transmit HIV as legally ‘guilty’ and the people who acquire it as ‘innocent victims’.  This sort of delineation is something that HIV organisations have worked hard to counteract for many years, and while it is understandable that people want justice when they have been deceived and infected by someone else, in some cases, it also has the potential to seriously damage the already fragile positive public image of people with HIV.

In Uganda, the aim is to prevent young people from being ‘preyed upon’ by older people who either believe that their AIDS can be cured by sleeping with a virgin, or who are engaging in transactional sex (whereby they provide gifts or money in exchange for sex).  This goal is laudable, but the penalty seems excessively harsh, given how frequently this sort of transmission probably takes place.

In California, the recent ruling has arisen from a court case brought by a married couple, both HIV+ who each accuse the other of giving them the virus.  The man in this particular case argued that he had never received a positive HIV test, and therefore could not have known he had HIV even if he was the person who had it first.  Under current Californian law (which makes non-disclosure of known HIV status to sexual partners illegal), this defence would be valid.  The court however ruled to change the law, so that ‘not knowing’ could not be used as an excuse – having had unprotected sexual encounters in the past was deemed sufficient for an individual to be aware of the risk that they had HIV, and could therefore pass it on.  

This has been welcomed by some as a measure to counterbalance the risk that people could be put off testing if they believed they may be prosecuted at a later date.  Others, most notably the Californian judge Justice Moreno, believe it is a step too far, saying the change "potentially licenses invasions into the sexual privacy of all sexually active Californians and may even invite abuse of the judicial process… One can easily foresee a spate of 'shakedown' or vengeance lawsuits brought by plaintiffs whose motivation is not so much to discover how they contracted H.I.V. as to force lucrative settlements or embarrass a former sexual partner by exposing that person's sexual history."

   
  US FDA approves first generic three-in-one AIDS drug                                                                 3rd July 2019
   
  The US Food and Drug Administration has tentatively approved its first generic three-in-one Fixed Dose Combination (FDC) antiretroviral drug for use under the US President’s Emergency Plan for AIDS Relief scheme.

The new pill, which combines the common anti-AIDS drugs zidovudine, lamivudine and nevirapine, needs to be taken just twice a day to effectively suppress HIV.  Manufactured by the Indian generic drugs firm Aurobindo Pharma Ltd, the drug is the first complete ‘all-in-one’ pill to be licensed for use in developing countries by the FDA.

Three-in-one FDCs such as this have been available to those funding treatment schemes through sources other than PEPFAR for a number of years.  However, the US government dictates that no drug can be purchased with PEPFAR money that has not been approved by its own FDA.  As generic drugs containing products that are still under patent cannot legally be sold in the USA, the FDA has to issue special ‘tentative’ licenses to ensure they are available for purchase elsewhere.  To date, the FDA has approved 23 such products, a number of which are suitable for use in children.  

The addition of this latest FDC has been warmly welcomed by those who are currently running PEPFAR-funded treatment schemes in developing countries.  If governements and AIDS organisations are ever to meet the All by 2010 treatment goal (which aims to get as close as possible to universal treatment access by 2010), such simplified and cost-effective regimens must become more widely available.  Treatment simplicity is also essential in ensuring that people with HIV adhere to their drug regimens.  If doses are missed, it gives HIV a chance to mutate and become resistant to the medication, making it far harder to prevent the virus from multiplying.
   
  Uganda running out of life-saving drugs                                                                                    30th June 2019
   
  Uganda has one the largest antiretroviral treatment programmes in Africa, with more than 70,000 people relying on the medicine to keep them alive. Now AIDS activists warn that drug stores are running perilously low, and could be exhausted by August.

According to souces contacted by the Daily Monitor newspaper, the crisis has arisen because of sloppiness in procurement combined with overspending on administrative costs. New funding from the Global Fund to Fight AIDS, TB and Malaria, which supports around half of those on treatment, has been delayed. Last year the Fund suspended all payments to Uganda, and since the ban was lifted in November there has been no new procurement of drugs.

“Even national referral hospitals would be running out of antiretroviral drugs because the support from the Global Fund has been delayed by procurement,” said Tonny Takenzire of the NGEN+ network. He said that some treatment centres had already stopped recruiting new patients.

This claim was confirmed by an anonymous official at the Bethlehem Medical Centre, who said their programme had reached "full capacity", and was not enlisting any more clients.

Dr Sam Okuonzi, programme coordinator for Ernst & Young, the caretaker managers for the Global Fund, acknowledged that drug supplies were running low. He said that arrangements were underway to procure more drugs but the process was being delayed because there was only one supplier.

It is essential that people who have started taking antiretroviral treatment continue to receive an uninterrupted supply of medication. If the drugs are not taken daily then HIV can become resistant to their effects.
   
  South African HIV/AIDS drama has significant impact on teen behaviour                                     29th June 2019
   
  A South African TV drama that focuses on a group of young people in a rural area of the Eastern Cape has shown success in reducing risky sexual behaviour among teens.

The drama, which was developed and produced through a collaboration of The South African Broadcasting Corporation (SABC), Curious Pictures, the Centre for AIDS Development Research and Evaluation (CADRE), and the Health Communication Partnership (HCP), is broadcast in the local Nguni language, but has English subtitles to make it accessible to non-Nguni speakers.

Tsha Tsha, as the drama is known, is broadcast weekly and focuses on the lives of several young people dealing issues of sex, relationships and HIV, as well as the more mundane dilemmas of everyday life in rural South Africa.  It attracts over 1.8 million viewers every week and is accompanied by a modified radio version that reaches 6 million listeners on community radio.  Many schools and community centres broadcast the drama for those who do not have televisions at home.

Research conducted on Tsha Tsha’s impact uncovered positive results.  When comparisons were made between those who had watched the drama and those who hadn’t, they discovered that Tsha Tsha viewers were more likely to practice safer sex activities and to have a more positive and less stigmatizing view of HIV.  44% of viewers of the drama said they were faithful to their partners, compared to 27% of non-viewers.  51% of viewers also said they used condoms to avoid HIV, compared to 38% of non-viewers.

Interestingly, the researchers were also able to use new statistical techniques to control for ‘propensity to view’.  This meant that the differences found were almost exclusively due to the actual programme itself, rather than the fact that those who had access to a television and were watching Tsha Tsha were more likely to be practicing safer sex in the first place.

Media projects like this are believed to be effective because young people strongly identify with and aspire to be like the characters they see on television.  However, not everyone in South Africa has access to a television or watches the show, so other HIV prevention initiatives will always be necessary to help fight the illness at all levels of society.
   
  Gates Foundation to receive $31 billion from one of world's richest men                                       27th June 2019
   
  Warren Buffet, one of the richest men in the world, has agreed to hand over 80% of his $44 billion fortune to the Bill and Melinda Gates Foundation, it was announced on Monday.

Mr Buffett, a 75-year-old financier from Omaha in the USA, told reporters at the donation ceremony that he though Mr Gates “would do a better job of giving it away than I can,” before signing a pledge that would see a total of around $31 billion given to the Gates Foundation in annual instalments.

Since its inception, The Gates Foundation has granted over $5.8 billion to global health programmes, $1.1 billion of which went towards HIV and AIDS. $ 2.6 billion has also gone towards improving education in the U.S.  

In Botswana, Gates is supporting one of the biggest AIDS drug distribution programmes in the world, which has so far put more than 40,000 people on antiretrovirals.  A number of universities and scientists have also received grants from the Foundation to further their research into an HIV vaccine.  Buffett’s gift, the largest in US history, will enable the Gates Foundation to spend nearly $3 billion a year on overseas and US-based projects; a sum equivalent to one quarter of the entire United Nations annual budget.

Commenting on Mr Buffett’s donation, Bill Gates said, “It’s almost scary.  If I make a mistake with my own money it just doesn’t feel the same as making a mistake with Warren’s money.”

Gates’ fear is perhaps well founded. Distributing the huge sums acquired in this deal in a viable and effective way is going to be major challenge for the Foundation.  Finding projects that have the capacity to absorb and efficiently spend the grants that they make has already proved difficult, and the extra money is likely to make things even harder.

Both Buffett and Gates have acknowledged as much, and say they have begun to seriously talk about the problem.  Both men are also personally committed to finding a solution: Bill Gates recently announced that he will soon be stepping down as the head of Microsoft to dedicate his time to his philanthropic work, and Warren Buffett will be joining the Foundation’s Executive Committee to oversee how his money is spent.
   
  US prepares for National HIV Testing Day                                                                                 26th June 2019
   
  27th June 2005 marks National HIV Testing Day in the United States, with hundreds of hospitals and organisations working together to highlight the importance of knowing your HIV status.

Around 250,000 Americans are currently believed to be unaware that they are infected with HIV, which represents approximately a quarter of those living with the virus nationally. The organisers of National HIV Testing Day, the National Association of People with AIDS (NAPWA), hope to reduce this number by encouraging people to "Take the Test and Take Control". Many hospitals, clinics and community centres across the country will be offering free HIV tests, some of which may provide results in as little twenty minutes. HIV and AIDS charities and organisations are also working together to stage events and awareness campaigns in many major towns and cities.

In Washington D.C., city officials are taking National HIV Testing Day particularly seriously.  They have launched one of the biggest testing campaigns in the history of the epidemic, with the aim of encouraging every resident aged between 14 and 84 to test for HIV.  The plan is to make HIV testing kits available at all medical care facilities so that receiving an HIV test can be as routine as having a blood pressure check.  Hundreds of thousands of free oral testing kits are now being dispensed to local clinics and doctor’s surgeries around the city.  If successful, the “Come Together DC, get screened for HIV” programme will mean every resident of the city will know their HIV status by the end of 2019.
   
  Disclaimer: This content is reviewed periodically and is subject to change as new health information becomes available. The information provided is intended to be informative and educational and is not a replacement for professional medical evaluation, advice, diagnosis or treatment by a healthcare professional. If you have or suspect you may have a health problem, consult your healthcare provider.
 
 

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