PrEP: time to rethink prevention, effectiveness and ethics?

via Somatosphere, by Marsha Rosengarten

One of the more controversial interventions proposed for HIV prevention in those who test HIV antibody negative and perceived to be at risk is pre-exposure prophylaxis (PrEP) – a daily pill comprising one or two antiretroviral drugs manufactured by Gilead Inc. Besides the mixed results from multi-site randomised controlled trials (RCTs) seeking to establish the efficacy of PrEP (see iPrEX versus Fem-PrEP), concerns have been raised about PrEP’s potential to undermine condom use, its cost implications in locales where treatment provision is still lacking and elsewhere, its potential to cause unwanted drug side-effects as well as possible drug resistance in those it fails to protect.

Nevertheless, continuing new infections and evidence that high adherence produces a strong protective effect are mobilising many public health authorities to devise feasible implementation models.

Most remarkable about the growing interest in PrEP is the exclusion of the social sciences from major forums where this work is taking place. One such example is a two-day forum held in the UK by IAPAC on the dual topics of treatment as prevention (TasP) and PrEP. The only non-biomedical speakers listed on the programme were a psychologist (speaking on adherence), a bioethicist, activists and public health officials linked to various national epidemics.

Indeed it won’t come as a surprise to many to know that despite the millions of dollars to support RCTs for PrEP, the Bill and Melinda Gates Foundation have so far declined to support a substantial programme of social research on PrEP. In fact if we consider the bioethical requirements imposed on the conduct of RCTs for PrEP and other biomedical interventions, there is no ethical requirement for research on the social dimensions of the intervention during or post RCTs. This applies even when RCTs demonstrate candidate efficacy.

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Antiretroviral Prophylaxis for HIV Prevention Reaches a Key Milestone

via Lancet.com, by Salim S Abdool Karim  and Quarraisha Abdool Karim

On May 10, 2012, a US Food and Drug Administration (FDA) advisory committee voted in support of the use of tenofovir-emtricitabine for HIV prevention.1 If the FDA, which is scheduled to make its decision by June 15, adopts the committee's recommendations, tenofovir-emtricitabine will become the first antiretroviral drug to be approved as pre-exposure prophylaxis (PrEP) for the prevention of HIV, paving the way for implementation.

PrEP has a unique advantage in young women in southern Africa, who bear a disproportionate burden of the HIV epidemic. In much of this region, young women are often unable to convince their male partners to use condoms, remain faithful, or have an HIV test. To rely on her HIV- positive discordant male partner to come forward to test, to agree to take antiretroviral therapy (ART), and to take his ART with high adherence, all for her protection, puts a woman's risk of acquiring HIV back in the hands of men, thereby disempowering women and undermining their efforts to control their risk of HIV.

However, there are several criticisms and concerns about PrEP. First, that data on the effectiveness of PrEP, especially in women, are inconsistent. This concern is based on the results of two PrEP studies—the FEM-PrEP2 and VOICE3, 4 trials—which were stopped, at least partly, earlier than planned when they did not show efficacy. To some extent, this concern has been allayed by recent data from the FEM-PrEP trial5 which show that adherence to daily tenofovir-emtricitabine in the trial was too low allow assessment of efficacy. Data to explain the VOICE trial, which still has an ongoing tenofovir-emtricitabine group, are not expected until 2013.

Second, some suggest that antiretroviral drugs should be provided to HIV-negative people only when all eligible HIV-positive patients are receiving ART. Although it is a legitimate concern that eligible HIV-positive patients should be prioritised for ART for their own health and to save their lives, it is spurious to trade off treatment and prevention as if these drugs are being taken away from sick and dying patients to be given to healthy people. Treatment and prevention strategies are a continuum in their use of antiretroviral drugs—both are needed in conjunction with each other to ensure ART provision is sustainable in the long term and to realise the quest to end the HIV epidemic.

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Two Studies Show the Importance of Adherence in PrEP at CROI 2012

via AidsMap.com, by Gus Cairnes

Adherence makes all the difference to the efficacy of pre-exposure prophylaxis (PrEP), the 19th Conference on Retroviruses and Opportunistic Infections (CROI) heard today.

Further data were presented from two trials of PrEP (giving anti-HIV drugs to HIV-negative people to prevent infection), which announced dramatically different results last year.

In April 2011, the FEM-PrEP study found that giving HIV-negative women tenofovir/FTC (Truvada) pills to prevent their acquiring HIV was totally ineffective: there was no difference in HIV incidence between women taking Truvada and women taking placebo.

In July 2011, however, the Partners PrEP study found that Truvada was 73% effective in preventing HIV transmission between heterosexual partners of different HIV status.

How do we explain why giving HIV-negative women antiretroviral pills made no difference to the HIV infection rate in one trial, but prevented at least two in every three infections in the other? The difference, it appears, is that in the Partners PrEP trial, adherence to the study medication was very high, whereas in FEM-PrEP, despite counselling and support, less than half the women took their PrEP pills regularly.

The Partners PrEP study

The Partners PrEP study enrolled 4758 serodiscordant couples in Kenya and Uganda; the HIV-negative partner was female in 38% of couples. This study had three arms: a daily tenofovir pill, a daily Truvada pill, or placebo.

There were 17 infections in participants on tenofovir, 13 on Truvada and 52 on placebo. Efficacy overall was 75% in those assigned Truvada and 67% in those assigned tenofovir, though confidence intervals (44% to 81% in tenofovir and 55% to 87% for Truvada) overlapped, so the efficacy of the two regimens was the same statistically. The same was true of efficacy observed in women (65%) and men (70.5%).

Adherence according to pill counts of unused medication was 97%. A substudy (Donnell) compared tenofovir levels in the blood of 29 out of the 30 people who became infected in the two PrEP arms with levels in a random selection of 198 people who did not become infected.

Tenofovir was undetectable in the blood of 70% of the people who became infected but only 18% of the people who did not, indicating a ‘true’ adherence level of about 80% – and having a detectable level of tenofovir in the blood was associated with an 86% reduction in HIV risk in those taking tenofovir and a 90% reduction in those on Truvada.

The FEM-PrEP study

In the FEM-PrEP study, 2056 HIV-negative women in South Africa, Kenya and Tanzania were randomised to take a daily Truvada pill or a placebo. The trial was stopped when an interim analysis found near-identical HIV infection rates in both trial arms. There were 33 HIV infections in women taking Truvada and 35 in women taking placebo; this translates into annual incidence rates of 4.7% and 5.0% respectively. This 0.3% difference is no difference at all, statistically speaking (hazard ratio 0.94, 95% confidence interval 0.59 to 1.52, p = 0.81).

Participants in the study said they took their pills 95% of the time and adherence as measured by pill count was 85%. However when drug levels of tenofovir and FTC were measured in the blood of women assigned to Truvada, the investigators found that less than 50% of the women who should have been taking the drug had actually done so in the last 12 days, and less than 40% within the last 48 hours.

In infected participants, 26% had detectable levels of tenofovir in their blood in the last visit before they tested HIV positive, 21% at the visit they tested positive, and 15% at both visits; in non-infected participants whose samples were taken at the same visits they were 35%, 38% and 26% respectively.

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[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

FEM PrEP Study Releases Trial Results

via MedPage Today, by Ed Susman

Pre-exposure prophylaxis with antiretroviral drugs failed to prevent women in Africa from becoming infected with human immunodeficiency virus (HIV) – apparently because more than half the women failed to take their medication.

The incidence of HIV infection among previously uninfected women treated with a co-formulation of emtricitabine and tenofovir (Truvada) was 4.7 per 1,000 person-years compared with a rate of 5 per 1,000 patient-years among women in the placebo group (P=0.81), said Lut Van Damme, MD, PhD, senior scientist at FHI 360, in Durham, N.C.

In a press briefing here at the Conference on Retroviruses and Opportunistic infections, Van Damme said it was likely that lack of adherence resulted in the failure to show a difference between those women on the active antiretrovirals and those who received placebo.

"The women in the study seriously overestimated adherence," she said. The participants told researchers that they took their assigned medicine 95% of the time. Pill counts indicated that 85% of the pills were not returned at regular points in the trial. But tests for emtricitabine/tenofovir in the blood of patients showed that only about 40% of the women had levels of the drug that would indicate the pills had been ingested within 48 hours of the tests.

The study was stopped early when an interim analysis showed that it was unlikely to prove positive.

The so-called FEM-PrEP was a randomized, double-blinded, placebo-controlled trial of once-daily oral emtricitabine/tenofovir. The primary effectiveness endpoint was incident HIV infection during 52 weeks of follow-up.

Participants attended screening, enrollment, and follow-up visits monthly. HIV seroconverters were taken off the product and followed for an additional 52 weeks

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[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

Differing Truvada Drug Levels in Vaginal and Rectal Tissue Offer Clues to HIV PrEP Puzzle

via HIVandHepatitis.com, by Liz Highleyman

The 2 drugs in the Truvada pill -- tenofovir and emtricitabine -- reach different concentrations in human cervical, vaginal, and rectal mucosa tissues and fluids, according to new research published in the December 7, 2011, issue of Science Translational Medicine. Lower drug levels in the female genital tract suggest that women may need higher doses to achieve a prophylactic effect, which may help explain conflicting results from some recent biomedical HIV prevention trials.

A series of large trials over the past 2 years have produced mixed findings about the benefits and risks of pre-exposure prophylaxis (PrEP), or use of antiretroviral drugs by HIV negative people in an effort to prevent infection.

The iPrEx study of gay and bisexual men in several countries and the TDF2 trial of heterosexual women and men in Botswana both showed that daily oral tenofovir/emtricitabine dramatically reduced the risk of HIV infection when given along with risk-reduction counseling, free condoms, and other prevention services.

The Partners PrEP trial of serodiscordant heterosexual couples found that both daily tenofovir/emtricitabine and oral tenofovir alone reduced the risk of infection, by 73% and 62%, respectively.

In contrast, the FEM-PrEP trial did not find a prevention benefit of daily oral tenofovir/emtricitabine for heterosexual women in Kenya, South Africa, and Tanzania; that trial was halted this past April after an interim review showed a similar number of new HIV infections in the tenofovir/emtricitabine and placebo arms.

Most recently, the VOICE trial, looking at women in South Africa, Uganda, and Zimbabwe, halted its oral tenofovir monotherapy arm in September after an interim analysis found that the study could not demonstrate that it was more effective than placebo. But another study arm testing tenofovir/emtricitabine was  allowed to continue, suggesting the combination performed better in the interim analysis.

The reasons for these conflicting results are not clear, but researchers have noted that, overall, tenofovir-based PrEP appears to work somewhat better for men than for women, leading some to speculate that the drugs may not behave the same at different anatomical sites.

Kristine Patterson and Myron Cohen from the University of North Carolina Chapel Hill and colleagues designed a study to look at pharmacological properties of tenofovir and emtricitabine in genital and colon-rectal mucosal tissue from 15 healthy HIV negative volunteers, 8 men and 7 women.

Cohen was the principle investigator of the HPTN 052 study -- presented to much fanfare at the International AIDS Society conference this summer in Rome -- which showed that if the HIV positive partner in a serodiscordant couple started immediate ART upon diagnosis regardless of CD4 cell count, the risk of HIV transmission was reduced by 96%; HPTN was mostly conducted in low- and middle-income countries, however, and use of tenofovir/emtricitabine was uncommon (10% overall, but zero at several sites).

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[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

Closure of oral Tenofovir arm in VOICE Pre-Exposure Prophylaxis trial: PrEP as a “niche intervention”?

via Incidence, by Roger J. Tatoud

The Microbicides Trial Network (MTN) September 28th that its VOICE (Vaginal and Oral Interventions to Control the Epidemic, MTN003) HIV Pre-Exposure Prophylaxis (PrEP) prevention study will discontinue the daily oral tenofovir arm of the trial. The decision follows an interim review of the trial’s data by its Data Safety and Monitoring Board (DSMB) which recommended that VOICE stops evaluating the oral tenofovir tablet (TDF, brand name Viread), because it will not be possible for the study to show a difference in effect between the drug and the placebo tablet (futility) for the prevention of HIV infection in the context of that study. Importantly, the DSMB did not found any safety issues associated with the use of TDF in any arm of the trial.

This is the third PrEP trial, after FEM-PrEP and TDF2, for which an interim review of the trial’s data led to a change of course of the study. Because the four other arms of the VOICE trial continue, there are no data available publicly yet to explain why tenofovir would not show effectiveness in this study when three other studies showed a dramatic reduction in the risk of HIV infection with tenofovir alone or in combination with another antiretroviral (see table below). However, Sharon Hillier and Ian McGowan of the Microbicide Trials Network noted that the study’s population – predominately women in their 20’s, could be an important factor.

“If there’s one thing we’ve learned over the years it’s that unmarried women in their 20s are in a very different place in their lives than married women in their 30s. People in different circumstances will make different choices about their use of condoms, their choice of partners and whether or not to use a biomedical prevention product. As we continue the VOICE trial we recognize that there could be many factors that influenced the outcome with oral tenofovir, and even when we have more information available to us, understanding what exactly happened (or not) will not be simple.”

If confirmed (a full analysis of the data will not be available before several months) this would add to the challenge of defining a strategic use for PrEP in the general population or in populations at risk.

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[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

The Latest Treatment Action Campaign (TAC) Briefing - Antiretrovirals and Prevention

via the Treatment Action Campaign (TAC), by Catherine Tomlinson and Nathan Geffen

Exciting new evidence has demonstrated the potential of antiretroviral medicines (ARVs) to prevent HIV from being sexually transmitted. This TAC briefing explains the evidence and then discusses policy implications.

Our recommendations

1.The WHO must release its guidelines on serodiscordant couples.
2.People living with HIV should be offered highly active antiretroviral treatment (ART) when their CD4 counts fall below 350 cell/mm3, or if they have an AIDS illness or TB.
3.HIV-positive people in serodiscordant couples should be offered ART irrespective of their CD4 count.
4.For serodiscordant couples trying to conceive, both partners should be offered ARVs until conception is confirmed, after which the HIV-positive partner should continue on ART.
5.Pre-exposure prophylaxis (PrEP) should be made available to sex workers.
6.In other cases, pre-exposure prophylaxis should be made available to HIV-negative people who request it or who will --in the opinion of their nurse or doctor-- likely benefit from it.
7.The rollout of ARVs for prevention must not divert funding away from treatment programmes. Achieving universal access for people with HIV must remain the priority for governments, policy makers and funders.
8.Effective prevention interventions such as voluntary medical male circumcision and ensuring availability of male and female condoms continue to be critically important.

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[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

Open-Label Extension of iPrEX HIV PrEP Study Begins at 11 Sites in 6 Countries

Via iPrEX News.

The iPrEx Open-Label Extension Study (iPrEx OLE), the next phase of the first human study to report efficacy results on pre-exposure prophylaxis (PrEP) to prevent HIV infection, has begun at clinical trial sites around the world. Approximately 2,000 men and transgender women who have sex with men are expected to participate in the 72-week iPrEx OLE study. Study sites in the United States and South Africa are enrolling participants now, as other study sites finalize the regulatory approval process.

In PrEP, antiretroviral medications that are usually used to treat HIV are taken by uninfected people to reduce their risk of infection. The iPrEx study found that men and transgender women who have sex with men (MSM) who took a single daily tablet containing the HIV medications emtricitabine and tenofovir (FTC/TDF), known commercially as Truvada®, experienced an average of 44% fewer HIV infections than those who received a placebo (blank pill). HIV infection rates in the iPrEx study dropped by 90% among those who used PrEP consistently enough to have detectable drug in the body. The HIV risk reduction benefits of PrEP were in addition to those provided by safer sex counseling, condoms, HIV testing and the detection and treatment of sexually transmitted infections. iPrEx study results were published in the New England Journal of Medicine in November, 2010.

The news of the start of iPrEx OLE follows the announcements by two other major PrEP studies, Partners PrEP and the CDC study in Botswana, known as TDF2, which demonstrated the safety and efficacy of PrEP in heterosexual women and men.

AdvertisementiPrEx OLE is a continuation of the iPrEx study that will collect additional data on PrEP efficacy, safety and adherence. All HIV-negative participants who took part in the original iPrEx study and who wish to participate will receive FTC/TDF for HIV prevention for 72 weeks through iPrEx OLE. No placebo will be used in the Open Label Extension.

"We are in a critical moment in HIV prevention research," said iPrEx Protocol Chair Robert Grant, MD, MPH of the Gladstone Institutes and the University of California at San Francisco. "iPrEx provided the first proof of an important new method of HIV prevention that can help slow the global toll of 2.6 million new HIV infections each year. Partners PrEP and the TDF2 study have now expanded that finding by demonstrating the effectiveness of PrEP in heterosexual women and men. Developing and deploying proven HIV prevention methods -- including PrEP, microbicides, vaginal gels, clean needles, medical male circumcision, early treatment, counseling, testing, condoms and suppressive therapy for pregnant women will all be key to slowing the global epidemic."

Read the rest here.

[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

WSJ: Trial Halted on HIV Pill for Women

[of interest: "There is research, as yet unpublished, showing that the concentration of tenofovir, when taken orally, is higher in rectal tissue than in vaginal tissue, said Timothy Mastro, an FHI vice president who spoke on behalf of the study. If so, the men might have had more of the drug than the women at the site where they were exposed to the virus."]

via Wall Street Journal, by Mark Schoofs

A highly anticipated trial to determine whether AIDS drugs taken by mouth can ward off HIV infection in women has been stopped early, a setback that surprised researchers after a string of successes in preventing transmission of the disease.

Researchers said Monday they had called off the trial among high-risk women in Africa because they wouldn't be able to determine whether use of antiretroviral medication produced any benefit. The study tested whether taking the medication once a day could prevent uninfected women from contracting the AIDS virus, estimated to infect more than 2.5 million people each year.

Several researchers lamented the result as "disappointing" and surprising. The same prevention method was proved successful just last year in a multicountry trial among gay and bisexual men. Moreover, an AIDS drug applied to the vagina in a topical gel—rather than swallowed as a pill—demonstrated a protective effect last year among women.

Researchers speculated that participants in the most recent trial might not have adhered to the regimen as closely as the participants in the other trials. Physiological differences between men and women might also account for the differences between this trial and the one among gay and bisexual men.

But a particularly intriguing hypothesis, supported by other research, is that swallowing a pill might not lead to high enough drug concentrations at the site where HIV enters a woman: in the tissues of the vagina.

In another surprise finding, women in the study taking the antiretroviral medication were more likely to get pregnant than women taking a placebo. This was true despite the fact that 96% of women in the study were on oral or injectable contraceptives when the study began.

There is no known interaction between the antiretroviral drugs and hormone contraceptives, said researchers. They said they would analyze their data to try to tease out if there might be such an interaction.

The randomized, placebo-controlled trial, called FEM-PrEP, was carried out among 1,951 women in South Africa, Kenya, and Tanzania by FHI, a non-profit health and development organization, with about $23 million in funding from the United States Agency for International Development and about $3 million from the Bill and Melinda Gates Foundation.

Approximately half the women were given Truvada, a pill that combines two antiretroviral medications, tenofovir and emtricitabine; the other half were given a placebo. Fifty-six infections occurred overall, with half among women taking a placebo and half among women taking the active drug.

Truvada is marketed world-wide by Gilead Sciences Inc., based in Foster City, Calif. In a statement Monday, the company said, "While this development is a disappointing one, Gilead believes that antiretroviral therapies remain a promising potential HIV prevention strategy."

Clinical trials are typically reviewed at regularly scheduled intervals by an independent committee. Such a committee decided that, statistically, the FEM-PrEP trial could not answer the fundamental question of whether Truvada reduces the risk of HIV infection. So the committee recommended closing the trial. Two other studies in Africa are continuing that could resolve the issue of whether AIDS drugs taken orally can prevent HIV infection in women.

Last year, a study of Truvada among gay and bisexual men showed it reduced the chance of infection by about 44%. There is research, as yet unpublished, showing that the concentration of tenofovir, when taken orally, is higher in rectal tissue than in vaginal tissue, said Timothy Mastro, an FHI vice president who spoke on behalf of the study. If so, the men might have had more of the drug than the women at the site where they were exposed to the virus.

Last year, another trial in South Africa showed that women could be protected against HIV by applying to their vaginas before and after sex a gel containing tenofovir, one of the two medications in the pill taken by the women in the latest study.

However, research presented earlier this year at the Conference on Retroviruses and Opportunistic Infections showed tenofovir concentrations in vaginal tissue were about 100 times higher when the drug was applied in the gel form compared with when it was taken orally.

One question researchers raised is whether women in the study took the pill faithfully. Dr. Mastro said his team would address this question by examining whether stored blood samples contain the medication.

[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

FHI to Initiate Orderly Closure of FEM-PrEP

via FHI website

Following a scheduled interim review of the FEM-PrEP study data, the Independent Data Monitoring Committee (IDMC) advised that the FEM-PrEP study will be highly unlikely to be able to demonstrate the effectiveness of Truvada [emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF)] in preventing HIV infection in the study population, even if it continued to its originally planned conclusion. FHI subsequently concurred and has therefore decided to initiate an orderly closure of the study over the next few months. The final analyses have not yet been conducted. At this time, it cannot be determined whether or not Truvada works to prevent HIV infection in women.

The FEM-PrEP clinical trial—implemented by FHI in partnership with research centers in Africa—is designed to study whether HIV-negative women who are at higher risk of being exposed to HIV can safely use a daily dose of a pill called Truvada to prevent infection. This study was funded by the United States Agency for International Development (USAID), with early funding from the Bill & Melinda Gates Foundation.

The FEM-PrEP outcome is surprising and disappointing, given a number of earlier studies suggesting the promise of pre-exposure prophylaxis (PrEP) using antiretrovirals. Most recently, the iPrEX study showed that use of Truvada can prevent infection in men who have sex with men at risk of HIV.

There are a number of possible reasons for the study findings, including low adherence to study regimen, a true lack of effect of the product among women (versus men who have sex with men), or other factors still to be determined. FHI will be conducting further analyses and will share additional findings in the coming months. The IDMC commended the trial team on a study conducted to a high standard with good follow-up and careful attention to good clinical practice and ethical standards.

Only preliminary FEM-PrEP data are available at this time:

• As of February 18, 2011, the study had screened 3,752 women and enrolled 1,951: 739 in Bondo, Kenya; 764 in Pretoria, South Africa; 432 in Bloemfontein, South Africa; and 16 in Arusha, Tanzania. The most common reason for women not being enrolled was existing HIV infection. The overall HIV prevalence was 21 percent among women screened for enrollment across the sites.
• Preliminary data indicate about 90 percent of the participants were retained in the study.
• Adherence to study product was approximately 95 percent when the study product was available for use.
• Women reported an average of 3.7 vaginal sex acts in the 7 days prior to enrollment, consistent with the average of 3.6 acts reported during follow-up.
• As of February 18, the approximate rate of new HIV infections among trial participants was 5 percent per year. A total of 56 new HIV infections had occurred, with an equal number of infections in those participants assigned to Truvada and those assigned to a placebo pill.
• Women participating in FEM-PrEP used an effective method of contraception at the time of enrollment—66 percent were using injectables and 30 percent were using oral contraceptives. The overall pregnancy rate was 9 percent; the highest pregnancy rates were among women using oral contraceptives.
• The use of Truvada in FEM-PrEP was associated with some known side effects that were not serious.

Among study participants randomly assigned to the Truvada arm, observed pregnancy rates were higher than among women randomly assigned to the placebo arm. This is unexpected and inconsistent with known drug interactions involving tenofovir (TDF) and contraceptive hormones, and with known metabolic effects of emtricitabine (FTC). Possible explanations include differential pill adherence by group, previously undefined drug-drug interactions, chance, or a combination of factors (including yet unknown factors). FHI will conduct further analyses of these data.

FHI and its partners are especially grateful to the women whose willingness to participate and commitment to the study were essential. To the extent possible, all participants have been notified of the decision and are being asked to come to the study clinics for final visits. Study participants who became infected with HIV during the study are being followed by the study team for an additional year and are referred for appropriate medical care and treatment in their community.

When the follow-up of the HIV-uninfected women is complete in a few months' time, FHI will be conducting in-depth analyses of study data and blood specimens collected during the study to examine the factors contributing to the observed outcomes. FHI will also collaborate with scientists conducting other PrEP studies to compare findings and to better understand the results.

When available, the final results from FEM-PrEP will make a strong contribution to our understanding of the use of antiretrovirals for HIV prevention. FHI, USAID, and research partners in Africa are committed to finding new technologies and developing new strategies to protect women from HIV.

For more information, see the following fact sheets:

• Questions and Answers (PDF, 222 KB)
• About FEM-PrEP (PDF, 263 KB)
• Key Findings (PDF, 246 KB)
• Adherence (PDF, 230 KB)
• Community Engagement (PDF, 242 KB)
• Drug Resistance (PDF, 229 KB)
• Pregnancy and Contraceptive Effectiveness in the FEM-PrEP Trial (PDF, 217 KB)
• Safety (PDF, 220 KB)
• Socio-Behavioral Aspects of FEM-PrEP (PDF, 255 KB)

[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]