Antiretroviral drugs can be used to prevent HIV infection the results of the global iPrEx clinical trial, released today, show.
This is the first study to test the concept of oral pre-prophylaxis exposure (PrEP) among HIV-negative participants – and these promising results could change the field of HIV prevention.
Taking a daily dose of Truvada (TDF/FTC) 50% of the time offered roughly 50% protection to the gay men who took part in the trial, which was conducted across five countries.
The efficacy rose above 70% among participants who took the ARVs more than 90% of the time.
The findings are the third promising trial result since last year.
Last year the Thai RV144 vaccine showed modest protection of 31%.
The CAPRISA 004 tenofovir gel results, released in July, showed 39% protection for women in the microbicide trial.
And the iPrEx study shows a 43.8% efficacy overall among the 2499 participants.
The full report is published in the New England Medical Journal today.
The survey was conducted among more than 33 000 pregnant women aged 15-49 years old in some 1500 public health clinics in October last year.
The HIV prevalence rate among pregnant women in 2009 was estimated to be virtually the same as 2008: 29.4% compared to 29.3% the previous year.
Major findings of the report include:
* Pregnant women 30-34 years have the highest HIV prevalence at 41%;
* HIV rates have risen the most in women aged 35-39, from 29% in 2006 to 35% in 2009;
* Kwazulu-Natal is still the province with the highest prevalence, estimated at 39%; and
* Syphilis prevalence remains unchanged at 1.9%.
Releasing the survey on Thursday November 11, Health Minister Aaron Motsoaledi said that an extra R5.4 billion had been allocated for expanding ARV treatment, in the 2010-11 financial year.
An estimated 1.584 million South Africans older than 15 years need ARVs and 158 000 children, the report states.
Approved this week by the US Food and Drug Administration, Egrifta (tesamorelin) reduces abdominal fat as measured by CT scan.
Lipodystrophy is “a condition in which excess fat develops in different areas of the body, most notably around the liver, stomach, and other abdominal organs” the FDA said in a press release yesterday.
“The condition is associated with many antiretroviral drugs used to treat HIV.”
The Treatment Action Campaign explains that lipodystrophy can lead to fat gain around the stomach, breasts or shoulders and fat loss from the face, arms, legs and buttocks.
TAC says that it usually, but not always, develops slowly over months or years – and can “occur rarely in HIV positive people who are not on treatment”.
This visible side effect can impact on people’s self image and qualify of life.
Lipodystrophy is linked to stavudine, or d4T, which was first line therapy in South Africa until 1 April 1 2010 when updated clinical management guidelines were released.
“The updated guidelines will begin to phase out the use of stavudine (d4T) and start replacing it with tenofovir (TDF)… all patients experiencing side effects on d4T or zidovudine (AZT) will be switched to TDF,” the SA National AIDS Council announced at the time.
The FDA explained that Egrifta is a growth hormone releasing factor (GRF) drug that is administered in a once-daily injection.
Dr Curtis Rosebraugh from the FDA’s Center for Drug Evaluation and Research said: “The presence of excess fat with this condition may contribute to other health problems as well as affect a patient’s quality of life, so treatments that demonstrate they are safe and effective at treating these symptoms are important.”
The FDA reported that: “Egrifta was evaluated in two clinical trials involving 816 HIV-infected adult men and women with lipodystrophy and excess abdominal fat.
“Of these, 543 patients received Egrifta during a 26-week, placebo-controlled period. In both studies, patients treated with Egrifta experienced greater reductions in abdominal fat as measured by CT scan, compared with patients receiving another injectable solution (placebo). Some patients reported improvements in their self image.
“The most commonly reported side effects in the studies included joint pain (arthralgia), skin redness and rash at the injection site (erythema and pruritis), stomach pain, swelling, and muscle pain (myalgia). Worsening blood sugar control occurred more often in patients treated with Egrifta than with placebo.
“Whether Egrifta decreases the risk of cardiovascular disease or improves compliance with antiretroviral drugs has not been studied.”
The 3rd HIV and AIDS Workplace Conference to be held next week will focus on strengthening prevention efforts and research in the workplace.
“The conference will, for the first time, reflect on the intersection of workplace HIV responses, academic research and surveillance,” the organisers say.
The forum has also attracted delegates from other countries.
“Businesses cannot ignore the impact the pandemic has on productivity and the welfare of employees,” says senior researcher at the Health Economics and HIV and AIDS Research Division (HEARD), Gavin George.
“This conference will provide an opportunity to disseminate cutting-edge research that we hope will inform and improve prevention strategies in the workplace.”
The SA Business Coalition on HIV/AIDS (SABCOHA), HEARD, Wits Business School and the Foundation for Professional Development are major players in the private sector response to HIV/AIDS.
SABCOHA CEO, Brad Mears, says: “We aim to bring the private sector on board in playing a more participative role in addressing HIV and AIDS in the workplace.
“The conference offers business an opportunity to step back, reflect and review HIV and AIDS programmes in the workplace and to establish more results driven initiatives to ensure efficiency in addressing issues concerning the epidemic.”
“The 3rd HIV/ AIDS Conference invites the private sector, including business leaders, as well as concerned members of the community to attend the conference and “to take a more active role in addressing pertinent issues affecting business and African communities”.
The conference will take place from 9 – 11 November 2010 at the Gallager Estate, Midrand, Johannesburg , and the Minister of Health, Dr. Aaron Motsoaledi , will open event.
*To register for attendance, visit www.sabcoha.org/conference