PrEP proven protection against HIV
Effective use of PrEP means taking it consistently when engaging in risky behavior
Henriette Lamprecht – Currently between 23 000 and 24 000 Namibians are on pre-exposure prophylaxis (PrEP) as part of the country’s combination HIV prevention strategy which kicked off in 2017. The target for this year and in collaboration with the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) is to give an estimated 46 647 HIV-negative Namibians a way to help protect themselves from getting HIV. Those at high risk include but are not limited to the following, are HIV negative people in serodiscordant relationships with a partner who is not confirmed as virologically suppressed; all HIV negative people in serodiscordant relationships, regardless of viral load (VL) of the partner, who want to conceive; partner(s) of unknown HIV status; recent/ recurrent sexually transmitted infections (STIs); multiple and/ or concurrent sexual partners; history of inconsistent or no condom use; recurrent Post-exposure prophylaxis (PEP) users and a history of sex whilst under the influence of alcohol or recreational drugs.
In Namibia EQUIP Health is working closely with local implementing partners, health care providers and community members in the country to complete a demonstration project that will provide PrEP for up to a 1 000 sex workers and men who have sex with men through the Society of Family Health and the Walvis Bay Coordinator Group.
Another partner in the fight against HIV/Aids in the country is the International Training and Education Center for Health (I-Tech) who since 2017 been instrumental in Namibia’s prevention and treatment strategy. With regard to PrEP, I-TECH’s support in the country focuses on three key areas namely direct service delivery support for PrEP for adolescent girls and young women (AGYW); technical assistance to strengthen facility-based delivery of PrEP for priority populations; and technical assistance at regional- and national-levels.
PrEP involves the use of antiretroviral drugs to reduce the risk of becoming infected with HIV. Although oral PrEP is the only PrEP option currently approved for HIV prevention, other forms of ARV-based primary prevention, including the dapivirine vaginal ring and long-acting injectable cabotegravir are on the horizon as possible additions to the PrEP toolbox.
Two types of PrEP, both oral pills, have been approved by a regulatory body for use as prevention. TDF/FTC was the first oral PrEP method available (brand name Truvada), although in select countries generic options such as TDF/3TC and TDF are also available. To date, only TDF/FTC has been approved for all populations. F/TAF, (brand name Descovy) is a newer addition to the prevention portfolio. In 2019, F/TAF was approved by the US FDA for daily use by cisgender men and transwomen. A trial is planned to investigate efficacy in cisgender women.
According to prepwatch.org a Dapivirine Vaginal Ring may also be available soon. Studies show that the ring, inserted monthly, reduces risk of HIV acquisition through a slow release of an ARV called dapivirine, with no safety concerns. After receiving a positive opinion from the European Medicines Agency (EMA) in July 2020, the ring is on track for WHO pre-qualification and will be submitted for licensure review in key African countries as well as by the US FDA.
Cabotegravir is an ARV currently being studied for use as PrEP. It was found to be safe and efficacious in two studies administering the drug, every two months, as a long acting injection. HPTN 083 enrolled cisgender men who have sex with men and transwomen and HPTN 084 enrolled cisgender women. Both trials will continue as open label extension studies, and the product will also undergo regulatory review.
A dual-prevention pill (DPP), an option which combines active ingredients from oral contraceptives and oral PrEP into one daily pill is also being studied. Results are expected in 2022. This kind of combination prevention is referred to as multipurpose prevention technology (MPT).
Other PrEP strategies in earlier phases of development include a monthly oral pill (islatrivir), a quick-dissolving vaginal film containing ARVs that can be inserted right before sex, and a long-acting implant that could offer protection for up to a year.
Although oral PrEP is a terrific HIV prevention tool currently available, it does not reduce the risk of chlamydia, gonorrhea, syphilis or herpes, and it does not prevent pregnancy
Although studies demonstrate that daily use ofTDF/FTC (Truvada) provides protection for all populations, and for cisgender men who have sex with men, an event-driven approach to dosing is also effective (taking a double dose of TDF/FTC between 2 and 24 hours before having sex and then, if sex occurs, one pill 24 hours after the double dose and another 24 hours later).
In October 2019, the US Food and Drug Administration (FDA) approved F/TAF (brand name Descovy) as daily oral PrEP for HIV prevention in men who have sex with men and transgender women. Due to lack of data on safety and efficacy, F/TAF is not approved for use by cisgender women. The drug manufacturer Gilead is designing a new trial to gather data on the efficacy of F/TAF in cisgender women, the results of which are expected in 2022.
There were no major adverse events observed in any of the trials. Some mild side effects were reported, the majority of which went away over time. With respect to F/TAF however, additional safety data still needs to be collected in the upcoming trial in cisgender women, as well as additional studies that will examine the effects of long-term use of the drug.
Effective use of PrEP means taking PrEP consistently when engaging in risky behavior (such as unprotected sex or sharing needles). Periods of risk will vary based on a person’s life circumstances, but as long PrEP is taken as prescribed during these periods, it will offer protection. - [email protected]
Sources: Pepfar; Unaid; I-Health; PrEPWatch
In Namibia EQUIP Health is working closely with local implementing partners, health care providers and community members in the country to complete a demonstration project that will provide PrEP for up to a 1 000 sex workers and men who have sex with men through the Society of Family Health and the Walvis Bay Coordinator Group.
Another partner in the fight against HIV/Aids in the country is the International Training and Education Center for Health (I-Tech) who since 2017 been instrumental in Namibia’s prevention and treatment strategy. With regard to PrEP, I-TECH’s support in the country focuses on three key areas namely direct service delivery support for PrEP for adolescent girls and young women (AGYW); technical assistance to strengthen facility-based delivery of PrEP for priority populations; and technical assistance at regional- and national-levels.
PrEP involves the use of antiretroviral drugs to reduce the risk of becoming infected with HIV. Although oral PrEP is the only PrEP option currently approved for HIV prevention, other forms of ARV-based primary prevention, including the dapivirine vaginal ring and long-acting injectable cabotegravir are on the horizon as possible additions to the PrEP toolbox.
Two types of PrEP, both oral pills, have been approved by a regulatory body for use as prevention. TDF/FTC was the first oral PrEP method available (brand name Truvada), although in select countries generic options such as TDF/3TC and TDF are also available. To date, only TDF/FTC has been approved for all populations. F/TAF, (brand name Descovy) is a newer addition to the prevention portfolio. In 2019, F/TAF was approved by the US FDA for daily use by cisgender men and transwomen. A trial is planned to investigate efficacy in cisgender women.
According to prepwatch.org a Dapivirine Vaginal Ring may also be available soon. Studies show that the ring, inserted monthly, reduces risk of HIV acquisition through a slow release of an ARV called dapivirine, with no safety concerns. After receiving a positive opinion from the European Medicines Agency (EMA) in July 2020, the ring is on track for WHO pre-qualification and will be submitted for licensure review in key African countries as well as by the US FDA.
Cabotegravir is an ARV currently being studied for use as PrEP. It was found to be safe and efficacious in two studies administering the drug, every two months, as a long acting injection. HPTN 083 enrolled cisgender men who have sex with men and transwomen and HPTN 084 enrolled cisgender women. Both trials will continue as open label extension studies, and the product will also undergo regulatory review.
A dual-prevention pill (DPP), an option which combines active ingredients from oral contraceptives and oral PrEP into one daily pill is also being studied. Results are expected in 2022. This kind of combination prevention is referred to as multipurpose prevention technology (MPT).
Other PrEP strategies in earlier phases of development include a monthly oral pill (islatrivir), a quick-dissolving vaginal film containing ARVs that can be inserted right before sex, and a long-acting implant that could offer protection for up to a year.
Although oral PrEP is a terrific HIV prevention tool currently available, it does not reduce the risk of chlamydia, gonorrhea, syphilis or herpes, and it does not prevent pregnancy
Although studies demonstrate that daily use ofTDF/FTC (Truvada) provides protection for all populations, and for cisgender men who have sex with men, an event-driven approach to dosing is also effective (taking a double dose of TDF/FTC between 2 and 24 hours before having sex and then, if sex occurs, one pill 24 hours after the double dose and another 24 hours later).
In October 2019, the US Food and Drug Administration (FDA) approved F/TAF (brand name Descovy) as daily oral PrEP for HIV prevention in men who have sex with men and transgender women. Due to lack of data on safety and efficacy, F/TAF is not approved for use by cisgender women. The drug manufacturer Gilead is designing a new trial to gather data on the efficacy of F/TAF in cisgender women, the results of which are expected in 2022.
There were no major adverse events observed in any of the trials. Some mild side effects were reported, the majority of which went away over time. With respect to F/TAF however, additional safety data still needs to be collected in the upcoming trial in cisgender women, as well as additional studies that will examine the effects of long-term use of the drug.
Effective use of PrEP means taking PrEP consistently when engaging in risky behavior (such as unprotected sex or sharing needles). Periods of risk will vary based on a person’s life circumstances, but as long PrEP is taken as prescribed during these periods, it will offer protection. - [email protected]
Sources: Pepfar; Unaid; I-Health; PrEPWatch
Kommentaar
Republikein
Geen kommentaar is op hierdie artikel gelaat nie