Study will involve 250 female participants from different parts of the country
Kampala, Uganda |FLAVIA NASSAKA| Makerere University scientists working on finding effective treatment for HIV/AIDS are marking another milestone with the start of trial of injectable Antiretroviral (ARV) therapy.
In a joint project with scientists from the Johns-Hopkins University of USA, they are recruiting participants for the study expected to kick off in October.
The initiative aims at ensuring people have a range of choices for treatment by establishing a possibility of injectable ARTs for people whose tolerance of tablets is low.
At a science café organized by the Health Journalists network in Kampala, Dr. Flavia Matovu Kiweewa, a Senior Researcher told The Independent that the new study is not about whether the injection works or not because tolerance and its safety have already been confirmed. What they want to establish is how effective it is compared to other drugs that are already being used.
The study will involve 250 female sex workers sourced from different parts of the country. It will not include vulnerable groups like pregnant and breast feeding mothers.
Kiweewa says participants will be initiated on either ARV tablets – Lamivudine and Truvada or an injection – with a combination of drugs Carbotegravir and Rilpivirine.
“The studies have been submitted to regulatory authorities. With the popularity of injections in Africa, we thought injectables are more effective both as PrEP (pre-exposure Prophylaxis – a drug given to prevent HIV among people who are at risk of infection) and treatment especially among women who are less empowered,” she said adding that they picked lessons from the injectable contraceptive which has become the most widely used method.
A similar study has already been done and results were presented at the International AIDS Society conference held in Paris from July 23 to 27. The results showed that people involved had their CD4 going up and those who were not feeling well became OK clinically. The trial was conducted at 50 centers in the U.S., Canada, Germany, France and Spain and showed patients who used injections every after four weeks suppressed the virus at 87% whereas those who took an injection every after eight weeks had their virus suppressed at 94%.
The design is that a participant will initially be given oral drugs and then given an injection of 600mls every after eight weeks. The intention is for the researchers to be sure that one is infected in order to avoid resistance. For those who will use it as PreP, the injection will be given at the time when one expects to be at risk.
Treatment as prevention
Kiweewa is optimistic that once found effective, the injection will avert thousands of infections and save many lives. “When people know the product works, they are able to use it”, she says citing the vaginal ring whose acceptability has been rising since the first study with the latest showing effectiveness of over 70%.
Kiweewa says a person living with HIV will be given an injection that will last two months something that will solve complications that come with poor adherence such as resistance that are caused by skipping tablets that are supposed to be swallowed daily.
“With everyone getting on treatment, we need easier ways. The next step is to have more user friendly ways to ensure patients take their drugs.”
Drugs have proved to be effective both as treatment and prevention. In fact drugs have almost halved deaths related HIV and increasingly it’s becoming rare to find a child born with the virus. If injection is approved, even more people will be saved. And, the news has caused excitement. For Moses Nsubuga who has lived with the virus for over 20 years such advances in research show we are closer to finding a cure. He being on second line ARVs takes a cocktail of seven drugs daily – aluvia, septrin and combivir. His choice would be trioday – one tablet day if only he was on first line. “My doctors have never changed my medication. They say never change a winning team but all these drugs taken daily are huge for a human being”, he laments adding “Whenever we hear of fixed dose interventions we get excited but they are nowhere to be seen here. We need a combination that will ease our treatment journeys.”
For Charles Brown of the Infectious Diseases Institute (IDI) if an injection is added to the HIV treatment plan, it means clients will have a choice to pick what’s best for them. To him choice is very important especially if someone is to adhere to the regimens.
“People will still have choice to take an injection or pills and with more advancement in research longer lasting initiatives such as implants will be invented. At the IAS conference for instance one scientist told us they are studying a drug that is able to expose the hiding strains of HIV. This drug they said will be used after one takes ARVs to undetectable levels”.
Brown however warns that people shouldn’t be excited as yet as the various stages of clinical research take time to translate into something that can be rolled out for general use.