WITH hope of an HIV injectable on the horizon set to change prevention of HIV to manageable levels, an injection administered every two months has shown success in clinical trials.
By Catherine Murombedzi Health Correspondent
Spouses in discordant unions are at risk of acquiring HIV. With condoms offering safe sex not generally practised, prevention before and after sexual encounters in general rely on pills for prevention.
Globally 1.7 million acquire HIV annually.
The pill burden faced by those taking pre exposure prophylaxis (PrEP) tablets may be a thing of the past as clients heave a sigh of relief. Promising results of an HIV injectable prevention is set to bring a new lease of life from an annual dosing of 365 days to six times per year.
In a statement recently released by the Data and Safety Monitoring Board (DSMB), the HPTN 083 study taken by the HIV Prevention and Trials Network (HPTN) noted success of the trials.
Efficacy trials of long-acting, injectable cabotegravir for HIV prevention has found cabotegravir to be 69% more effective in preventing HIV acquisition in men who have sex with men (MSM) and transgender women who have sex with men when compared to the current standard of care, daily oral tablets,” said the report.
● The HPTN 083 study, with approximately 4 600 participants across more than 40 sites in Argentina, Brazil, Peru, United States, South Africa, Thailand and Vietnam was taken from 2016.
● Among the 50 people in the trial who acquired HIV, 12 were randomised to the long-acting cabotegravir arm and 38 were randomised to the daily, oral tablets arm. This translated to an HIV incidence rate of 0.38%.
RATE OF INFECTION
● Annually, about 1.7 million people are infected with HIV hence the need for more preventive measures.
● The pill burden to the current oral tablets for daily use has seen some clients defaulting
● If approved, a new injectable agent, such as long-acting cabotegravir administered every two months, could play an important role in reducing HIV transmission and helping to end the HIV epidemic.
● The medication had less severe reactions at injection site hence there was no discontinuation due to intolerance.
● Why the target group? The HPTN 083 study enrolled HIV-negative men who have sex with men and transgender women who have sex with men, participants considered more at risk for HIV infection and usually left behind.
“These study results demonstrate that long-acting injectable cabotegravir dosed every two months can successfully reduce HIV acquisition in at-risk MSM and transgender women,” said Kimberly Smith, MD, Head of Research & Development at ViiV Healthcare.
The completion of the companion study HPTN 084 trials, which began in November 2017 will give important information about the effectiveness of cabotegravir in women.
New options are needed for HIV prevention that offer an effective alternative to daily oral PrEP.
Zimbabwe is taking part in the HTPN 084 clinical trials with more than 3 000 sexually active women in seven African countries have enrolled in HPTN 084, which is also co-funded by NIAID, ViiV Healthcare and the Bill & Melinda Gates Foundation.
As of now, cabotegravir has not yet been approved for the treatment or prevention of HIV as a single agent by regulatory authorities globally.
The head of the local clinical trial, Prof Z. Mike Chirenje MD, FRCOG, Principal Investigator, HPTN-084 Zimbabwe and Director – University of Zimbabwe College of Health Sciences Clinical Trials Research Centre is thrilled with the efficacy news.
The results are indeed good news for the entire HIV prevention research field. HPTN-083 is the first ever study to demonstrate that long-acting injectable Cabotegravir is effective in preventing HIV in humans. We are all excited that we may soon be adding another effective method to our toolbox of HIV prevention modalities for men. It is now important that robust evidence be accumulated for women for this exciting new intervention and that we, as HPTN 084 teams, continue to operate the trial, safely, during this COVID-19 pandemic,” said Prof Chirenje.
DR MGODHI ON CHOICES
Dr Nyaradzo Mgodhi, a local researcher of repute weighed in saying: “This is a significant milestone for the HIV prevention field. We need different options for preventing HIV infection to allow people best choices for their circumstances.” Dr Nyaradzo Mgodi MBChB, MMed, Investigator of Record, HPTN-084 Zimbabwe – University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, and HPTN Executive Committee Member.
The HPTN 084 study is a phase III double blind safety and efficacy study designed to evaluate the safety and efficacy of the long-acting injectable cabotegravir for HIV prevention administered every eight weeks compared to daily oral tablets in women who are at increased risk of HIV acquisition. HPTN 084 opened to enrolment in November 2017 and is being conducted at research centres in Botswana, Kenya, Malawi, South Africa, Eswatini, Uganda and Zimbabwe for 4 to 5 years.