Vaginal ring effective, acceptable

FEMALE condoms have not received favourable uptake, leaving women, particularly those in sub-Saharan Africa, with few options to protect themselves from sexually transmitted infections.

According to the National Aids Council 2015 annual report, female condoms had an uptake of 5 573 786 against 109 402 154 male condoms.

Moreover, some women are often unable to convince their partners to use condoms.

In the region, approximately 60 percent of new infections in the 15-24 age group occur among girls and young women, where unprotected heterosexual sex is the primary driver of the epidemic.

However, an updated adherence analysis from A Study to Prevent Infection with a Ring for External Use (ASPIRE) study indicates that consistent users of a vaginal ring containing dapirivine for HIV prevention is effective and acceptable.

In ASPIRE, HIV risk was reduced by about one-third, meaning that one in three women who might have acquired the virus did not.

Dr Nyaradzo Mgodi, the director of the ASPIRE study, said the dapivirine ring works in HIV prevention.

“ASPIRE suggests that even higher levels of protection can be achieved with regular and consistent use. Among women who appeared to use the ring most regularly, HIV risk was cut by more than half across all analyses, and in some, by 75 percent or more,” said Dr Mgodi.

“We want nothing more than for women in sub-Saharan Africa, and of course the world over, to have a means to be protected.”

The ASPIRE study evaluated the effectiveness of a vaginal ring impregnated with the anti HIV drug — dapivirine.

The ring, which is similar to devices used for contraception, is designed to be worn inside the vagina for a month at a time, releasing medication slowly over the time. Women can insert and remove it on their own.

The study recruited 2 629 women between the ages of 18 and 45 years from Malawi, South Africa, Uganda and Zimbabwe.

Stratified by age, the vaginal ring had zero effectiveness for women aged 18-21, reduced infections by 56 percent in women aged over 22-26 and reduced infections by 51 percent in women aged 27 and older.

“Across multiple analyses, there is a statistically significant relationship between ring use and HIV protection,” the researchers concluded.

“These analyses provide evidence suggest- ing a dose-response relationship between ring use and HIV acquisition.”

Women who took part in the study told researchers that they like the product because they found it easy to use and preferred it to possible alternatives such as tablets or vaginal gels.

The headline findings, released in February, were somewhat disappointing - an overall reduction in infections of 27 percent. But this masked a higher level of effectiveness for the older study participants, who may have had higher levels of adherence than the younger participants.

One of the participant interviewed by Dr Elizabeth Montgomery and Dr Ariane van der Straten of RTI International as heard at the 21st International Aids Conference held in Durban, South Africa in July, explained the ring as simple and discreet.

“I like it because once you wear it, you don’t fell it, and nobody can suspect you are wearing something. I like it because nothing changes in how we live as women,” one woman explained.

Ms Montgomery added that some participants’ misgivings about the research process could have contributed to lower adherence.

The development of an effective and acceptable microbicide comes after a series of studies that failed to show efficacy in HIV prevention.

The results of the study, Follow-on African Consortium for Tenofovir Studies (Facts 001), a vaginal gel using 1 percent Tenofovir proved to be ineffective.

The Facts 001 results refuted the findings of a similar study published in 2010 by the Centre for the Aids Programme of Research in South Africa (Caprisa).

Researchers in the Caprisa study sampled over 900 women in the KwaZulu-Natal province and reported that the Tenofovir gel was 39 percent effective at reducing the rate of HIV infection among these women.

Despite advances in preventing HIV, women — young women, especially — still face disproportionate risk, and a number of current prevention options, including oral pre-exposure prophylaxis (PrEP), may not be accessible to or practical for many women.

Dr Mgodi, however, acknowledges the ring may not be for everyone.

“While we are excited about the ring, it may not be the right approach for some women.

“Maybe they would prefer oral PrEP, or perhaps other approaches we are investigating, like long-acting injectables. It’s really about giving women choices,” she said.

“Ideally, women should be able to have choices when it comes to protecting themselves against HIV because no one approach will be right for all women, nor be right at all times in their lives.”

Women who took part in ASPIRE will soon be offered the opportunity to use the ring as part of a new study called HOPE.

The first sites for HOPE opened in July in KwaZulu-Natal, South Africa.

Other than South African sites, some will be opened in Malawi, Uganda and Zimbabwe between September and November as in-country approvals are received and other requirements are met.

HOPE (HIV Open-label Prevention Extension) will build on the results of ASPIRE by gathering information on the ring’s safety, how women use the ring knowing that it can help reduce their risk of HIV and the relationship between adherence and HIV protection.

“The study also seeks to understand why the ring may work well as an HIV prevention strategy for some women but not for others,” explained Dr Mgodi.

Dr Mgodi explained that in HOPE, there will be no usage of a placebo since it is designed to help move toward a more “real world” delivery model.

The monthly ring offered to women in the HOPE study contains an anti-retroviral (ARV) drug, dapivirine, as a way to provide women with potentially longer protection against HIV.

Dapivirine also known as TMC 120, belongs to a class of anti-retroviral drugs called non-nucleoside reverse transcriptase inhibitors (NNRTIs) that bind to and disable HIV’s reverse transcriptase enzyme, a key protein needed for HIV replication.

The HOPE study is expected to be completed by early 2018 and the comprehensive data on dapivirine and the ring, including findings from ASPIRE and from several smaller supporting studies, will be compiled into an extensive dossier which is anticipated to be submitted to regulators in 2017.

“If granted, the first regulatory approvals could be received as soon as 2018, within the same time frame that results of HOPE may be available,” said Dr Mgodi.

An Aids vaccine appears to be a long shot at the moment and in the meantime, scientists are keenly looking at other options that could prevent HIV.

HIV poses as a huge threat around the world with 35 million people living with the disease while 1,5 million people die from it every year.

However, this is in spite of new infections falling by 33 percent since 2001 due to the availability of ARVs.