By Francis Kagolo
The 4,758 HIV sero-discordant couples who participated in a research about Pre-exposure Prophylaxis (PrEP) hoped that the strategy would reduce new infections if adopted.
However, their wishes withered when the health ministry announced last week that it had rejected the HIV prevention strategy citing high costs and fears that it would increase promiscuity.
Pre-exposure prophylaxis (PrEP)
is a procedure where an HIV-negative adult, especially those in high risk sexual relationships like discordant couples, take HIV medication before being exposed to the virus, for instance prior to sex.
The method, which currently uses Truvada, a US manufactured drug, reduces the risk of catching HIV.
Unlike in the US where Truvada is mainly used by men who are at high risk of getting infected with HIV through sex with fellow men, Ugandan activists wanted the drug to be made available for discordant couples who are in urgent need of prevention strategies.
“After the failure of the vaginal microbicide, we thought Truvada would give HIV-negative partners in discordant relationships another method of preventing HIV other than condom use,” says Robert Ssebunya, a senior presidential adviser on Buganda matters, who chaired a community advisory group during the 2011 PrEP research.
How effective is Truvada
Truvada is a combination of two drugs; Emtricitabine and Tenofovir. According to the results of the study on the drug’s efficacy released in July, 2011, only 78 HIV infections were recorded out of the 4,758 HIV sero-discordant couples who participated.
This was over 85% effectiveness. Chances of not contracting HIV were slightly higher among individuals who used Tenofovir combined with Emtricitabine than those who took Tenofovir alone.
Of the 78 infections, 18 occurred among those assigned Tenofovir, 13 among those assigned to the combination of Tenofovir and Emtricitabine, and 47 among those assigned a placebo (a drug look-alike, but with unknown medical effects).
Funded by the Bill and Melinda Gates Foundation, the study was conducted in nine research sites in Kenya and Uganda. A total of 1,000 Ugandan discordant couples, mainly from the central region, participated.
“This is an extremely exciting finding in the field of HIV prevention. Now, more than ever, the priority for HIV prevention research must be on how to deliver successful prevention strategies, like PrEP, to populations in greatest need,” said Dr. Jared Baeten, an associate professor of global health and medicine at the University of Washington, who chaired the research team.
The results, together with other studies, convinced the US Food and Drug Administration to approve Truvada that very year, as the first medication to prevent HIV infections in people having sex with infected individuals.
The results were described as critically important for Africa, where the majority of new HIV infections occur.
Despite continued promotion of abstinence and condoms, national statistics still show that 74,400 (60%) of the 124,000 annual new infections in Uganda occur in stable relationships between HIV discordant couples.
Thus, Ssebunya argues that the number of new infections would reduce drastically if the problem was attacked from the side of discordant couples. This, he says, would in the long run reduce HIV prevalence, which has again increased to 7.3% from about 6% in 2006.
Why health ministry is opposed to Truvada
But the ministry thinks otherwise. Dr. Alex Ario, the anti-retroviral therapy (ART) programme coordinator, says a new policy in the ministry prohibits introduction of the Pre-exposure Prophylaxis.
Instead, the ministry has maintained the current treatment strategy, which focuses on Post-exposure prophylaxis (PEP)
and providing ARVs to people living with the virus.
Unlike PrEP where one takes the drug, for instance, before sex, post-exposure prophylaxis involves taking anti-HIV medications as soon as possible after one may have been exposed to HIV to try to reduce the chance of becoming HIV-positive.
In both procedures, the drug, when taken within 72 hours before or after being exposed, would weaken the virus and stop it from multiplying. The post-exposure treatment is accessed mainly by victims of rape and medical personnel who may come in contact with patients’ blood in the course of their work.
“We have conducted several studies and decided that it is not yet time to adopt Pre-exposure Prophylaxis in Uganda,” he said, citing the cost as one of the factors that do not favour introducing PrEP in Uganda.
There are also fears in the health ministry that the Pre-exposure prophylaxis, if adopted in Uganda, would instead encourage promiscuity and make the battle against HIV/AIDS backfire.
Dr. Ario also explained that it was not viable to provide drugs to people who do not have HIV, yet many of those who are infected have failed to access ARVs.
“Our guidelines do not recommend it (Truvada) anymore, not because it is a bad drug, but because it is expensive,” Ario explained. “We decided that instead of giving drugs to an HIV negative partner in a discordant relationship, for example, we concentrate on giving ARVs to an HIV-positive partner.”
Currently, more than half of the money sourced for HIV/AIDS work in Uganda goes to care and treatment.
Both the Government and non-government actors spent sh564.1b on treatment in the financial year 2008/2009 and sh596.5b in 2009/2010, according to the National AIDS Spending Assessment (NASA) report 2012.
Yet, over half of the 710,000 HIV positive Ugandans eligible for ARVs cannot get them because, officials say, funds are inadequate.
In comparison, only sh206.1b and sh212b was spent on prevention in the two years respectively, which is even less than sh237.7b consumed through management and administration.
A person’s daily Truvada dose costs about $35 (about sh90,000) in the US, but Dr. Ario says the cost would be higher if it is imported here.
However, Ssebunya and Lillian Kentutsi, the chairperson of the National Forum of People Living with HIV/AIDS Networks (NAFOPHANU), called the argument irrelevant.
“Whoever has done that (rejected PrEP) has not considered the consequences to the discordant couples who participated in our study, the time and sacrifice people put in the research,” Ssebunya said.
“How can you refuse a drug whose efficacy has been proved by research? Ugandans hoped that at last this drug would solve problems faced by discordant couples.”
Ssebunya feared that competitor pharmaceutical manufacturers might influence government technocrats to shun the new prevention strategy and urged the health minister, Dr. Ruhakana Rugunda, to probe the matter.
“Drug manufacturers play many political games. If a country like US has come up with a drug, other countries may not be happy. I hope no one is influencing our technocrats to prevent Truvada,” he said. “The cost is not an issue. Let us look at the effectiveness of the drug, and then we will look for the funds.”
Ssebunya said it is uncommon for a study on drugs to achieve 85% efficacy and asked the Government to reconsider its position for the greater good of discordant couples.
Kentutsi added: “You cannot say that pre-exposure prophylaxis will cause more promiscuity. The drug should be for HIV-negative people whose partners are positive.”
“We are not saying every person who is HIV-negative should be given the drug. We have known discordant couples that must be supported. It is not about being promiscuous. People living with HIV must be able to protect their partners.”
Alternative preventive measures and their challenges
Prof. Elly Katabira, who also worked on the PrEP study in 2011, has no problem with the Government rejecting the prevention strategy. He says there are other equally effective measures like abstinence and condoms, which discordant couples can use, and “besides the Government has to have priorities.”
“Effectiveness of the drug (Truvada) has been approved, but the health ministry can offer only what it can afford. If the Government cannot afford it, there are other prevention measures like abstinence,” Katabira said.
However, a study conducted by professors Jolly Beyeza and Florence Mirembe in 2009, revealed that abstinence and condoms may not work for discordant couples would like to have children.
“Couples wanting children and those with multiple sexual partners were less likely to use condoms.
Most safe sexual practices used by couples do not allow pregnancy to occur,” stated the report.
The study cited ensuring lineage continuity and posterity, securing relationships and pressure from relatives to reproduce as the main reasons for discordant couples wanting a child.
But the report says such couples are faced with several challenges like the risk of HIV transmission to the partner and child, lack of negotiating power for safer sex and failure of health systems to offer safe methods of reproduction.
“We need to address gender issues, risky behaviour and reproductive health services for HIV sero-discordant couples,” says the report.
“Pre-exposure prophylaxis would help HIV-negative partners in discordant relationships to also have children.
Denying them this chance is telling them to take the risk of infecting or allowing to get infected with the virus for the sake of a child. This is bad,” says Ssebunya.