SCULPTRA (Poly-L-lactic acid) for the treatment of HIV and HAART related facial lipoatrophy and restoration of facial contours and a youthful appearance

What is Sculptra?
It is a semi-permanent filler composed of polylactic acid which is injected to help correct facial lipoatrophy due to the ageing process or resulting from the side effects of certain drugs. Sculptra® or polylactic acid is a biocompatible, bioabsorbable synthetic polymer which is immunologically inert and has been around for 20 years and has proved to be safe.

How does it work?
It increases skin thickness through an initial bulk effect and subsequent stimulation of fibroblasts over time (weeks) to increase collagen production (months). This will result in the development of increased skin thickness but with the retention of normal skin appearance and texture.

What is Sculptra used for?
Sculptra is used to treat:
- scars and wrinkles
- fine lines, skin creases and furrows
- facial lipoatrophy* and volume loss
- to treat facial lipoatrophy related to HIV infection and HAART

Type of patients involved
- HIV + patients with facial lipoatrophy

How is Sculptra administered?
Poly-L-lactic acid is mixed with local anaesthetic and injected into the dermis of the skin. The treatment is administered every 2 weeks for a minimum of 3 sessions.

How long will the treatment take? Is it painful?
It takes between 30-45 minutes depending on the area being treated. The poly-L-lactic acid filler is mixed with local anaesthetic to numb the area being treated. The patient will experience pain from the needle pricks only. An ice-pack will be applied before the treatment to numb the skin before injecting.

What must I do after the injections?
Your dermatologist will provide specific aftercare instructions. You will need to massage the treated areas for a few minutes each night for several days after treatment.

How long will the filling effects last for?
A change in the facial contour is evident immediately due to the injected volume but this disappears after 48 hours once the fluid from the injected product is absorbed. Volume increase then occurs gradually 4 to 6 weeks following treatment providing gradual, natural-looking results. Its effects last up to 2 years following which a "top up" may be required.

Are there any side-effects?
Sculptra injection is a relatively safe procedure. Some potential side effects are injection related and transient. These may include bleeding, pain, local redness, bruising and swelling. In rare cases skin thickening and nodules have been reported but this was thought to be due to incorrect dilution techniques. Massaging the injection area after treatment can minimize the chance of occurrence of these nodules.

Is the volume enhancing effect of Sculptra permanent?
No. Although the effect of poly-L-lactic acid filler injections have been shown to persist beyond 2 years, its effects are not permanent and "top-up" injections may need to be administered.

* Valantin MA, Aubron-Olivier C, Ghosn J et al. Polylactic acid implants to correct facial lipoatrophy in HIV-infected patients: results of the open-label study VEGA. AIDS 2003; 17:2471-2477.

To book an appointment with Dr Priya Sen, Associate Consultant for the above procedure, please call the National Skin Centre at 63506666.

Nonoccupational Postexposure HIV Prophylaxis

Doctors who manage patients with sexually transmitted infections may be confronted with the scenario of a patient requesting for nonoccupational postexposure (NOPEP) HIV prophylaxis in the clinic. In such a situation, the physician should assess the likelihood that HIV will be transmitted as a consequence of the exposure, and advise the patient about the risks and benefits of treatment. Appropriate counseling must be given, and if the decision is made to treat, follow up care for potential side effects of medication, repeat HIV testing and reinforcement of counseling messages must be done.

Introduction

Antiretroviral therapy (ART) offered as PEP has become the standard of care for healthcare workers who have had occupational exposure to HIV. A case-control study has demonstrated that PEP with zidovudine was associated with an 81% decrease in the odds of HIV transmission with a percutaneous exposure in the occupational setting.¹ Although there is no data to show that ART is effective at preventing transmission from nonoccupational exposures, the principles of managing patients with recent HIV exposure are similar whether the exposure occurs in an occupational or nonoccupational setting.

HIV Exposure Risk Assessment

A detailed and careful history of the exposure event is the first step in evaluating a patient.

Table 1 shows the risk of HIV transmission following a single percutaneous occupational, sexual, or injection drug exposure.2 Patients should be told that these are estimates, and in reality, the odds of infection with a specific exposure are hard to estimate because the risk of HIV transmission is affected by many factors such as the viral load of the infected person, presence of other sexually transmitted diseases, the size of the inoculum, and so forth. Certain sexual practices (receptive anal intercourse) carry much higher risk than others (insertive oral sex).

Generally, exposures to saliva, urine, tears and sweat are not though to be infectious, and the risk of HIV transmission from splashes of contaminated fluids to mucosal surface or nonintact skin has not been accurately quantified, although it is likely to be low.

Criteria for NOPEP against HIV

The following criteria should be used:

• There is high risk exposure (any unprotected anal or vaginal intercourse, receptive fellatio with ejaculation) with: (1) a partner known to be HIV-infected, or (2) in HIV-risk group (men who have sex with men, bisexual men, IV drug users, commercial sex workers), or (3) patient was raped.
• Patient must be counseled and make a commitment to safe sex
• Patient must make an informed decision regarding potential risks and benefits of the treatment offered
• Exposure must have taken place within the last 72 hours, as initiating PEP after 72 hours is not advised

Regimen

The Department of STI Control Clinic (DSC) offers a triple drug combination of Combivir^® (zidovudine/3TC) 1 tablet BD with nelfinavir (Viracept^®) 750mg TID for a total of 28 days. The cost to the patient is approximately $1400 at the time of writing.

Side Effects

The drugs used can all cause GIT side effects i.e. nausea, diarrhoea, anorexia

ZDV: most side effects are dose-related; major side effect is haemtaological - anemia, granulocytopenia; pigmentation of nails reported

3TC: well-tolerated; rash, hairloss, vasculitis, photophobia, paraesthesia

Nelfinavir: main side effect is diarrhoea in up to 52% of patients; elevated liver enzymes

Baseline Tests and Follow Up

Baseline HIV test is performed

Full blood count, liver and renal function tests; these will detect any preexisting abnormality prior to treatment and can be repeated if necessary

Patients should be seen after 2 and 4 weeks to assess compliance and possible side effects of medication, as well as to reinforce prevention messages

Counseling Patients

It is important to counsel patients that:

• There is no absolute proof that ART PEP decreases risk of HIV, although there is supportive evidence based on biologic plausibility, animal studies and in a single study on HCW
• The treatment is not 100% effective, as there have been documented cases of seroconversion after occupational exposures despite PEP
• Side effects will be encountered with medication
• Most importantly, issues of safer sex and how to prevent future exposures must be addressed

References

¹ Cardo DM, Culver DH, Ciesielski CA, et al. A case-control study of HIV seroconversion in health care workers after percutaneous exposure. N Engl J Med 1997; 337:1485-90.

² Katz MH, Gerbeding JL. Management of occupational and nonoccupational postexposure HIV prophylaxis. Current Inf Dis Reports 2002; 4:543-9.

³ Gerbeding JL. Prophylaxis for occupational exposure to HIV. Ann Intern Med 1996; 125:849-56.

⁴ Vittinghoff E, Douglas J, Judson F, et al. Per-contact risk of human immunodeficiency virus transmission between male sexual partners. Am J Epidemiol 1999; 150:306-11.

⁵ Peterman TA, Stoneburner RL, Allen JR, et al. Risk of human immunodeficiency virus transmission from heterosexual adults with transfusion-associated infections. JAMA 1988, 259:55-8. [Erratum, JAMA 1989; 262:502]

⁶ Kaplan EH, Heimer R. A model-based estimate of HIV infectivity via needle-sharing. J Acquir Immune Defic Send 1992; 5:1116-8.

Topic – Genital rashes
Please note that this article is only for information and you should always see your doctor if you have developed any symptoms and are uncertain if you have an STD.

GENITAL RASHES – NON-STD RELATED
The external genitalia are a common site for rashes, itching, and minor infections. The various possible causes can be discussed under the following categories: (1) Red (inflammatory patches) (2) White patches (3) Skin coloured lumps and bumps.

		Endogenous eczema (‘sensitive skin’) Patients may already have a history of eczema or ‘sensitive skin’, or they could initially experience itch that may be caused by a yeast infection, heat, moisture, or any irritant. Repeated scratching can cause breaks in the skin and secondary infection. Over the scrotum, the skin can become very thickened, and can sometimes resemble ‘elephant skin’. This is a process called ‘lichenification’. Treatment consists of topical corticosteroids, antihistamines and avoidance of irritants. Secondary infection of excoriated skin may require a course of antibiotics.
		Contact dermatitis This can occur as a result of irritation or from an allergic reaction to something applied. The most common irritants are soaps, topical medicaments, urine, faeces and infected or copious vaginal secretions. Irritant contact dermatitis of the genitalia presents with redness and itching.
		Lichen planus This is a disease where the cause is unknown. It can affect the skin, mouth, nails and genitalia. It is usually itchy and causes pinkish or purplish small bumps to appear, sometimes with a lacy white streak on the surface. You should see your doctor if you suspect you have lichen planus. Topical corticosteroids are used.
		Psoriasis There are usually manifestations of psoriasis elsewhere on the body. Psoriasis is a chronic skin disorder that also affects the scalp and nails. It causes pinkish spots or small patches to appear on the genitalia, and may be itchy and scaly.
		Fungal infection Tinea cruris (jock itch) is caused by a ringworm type of fungus. It affects the groins. Candida is a type of yeast infection that causes vaginal discharge and rash, and also balanitis – an inflammation of the penis. If you have severe or recurrent candidal infections, you should see a doctor and also have investigations to exclude diabetes.
		Plasma cell (Zoon’s) Mucositis This presents as a balanitis in males. It appears as a moist, shiny, erythematous, well-demarcated plaque on the glans penis. It is benign and can be treated with a topical corticosteroid. However, a biopsy is often required to differentiate it from erythroplasia of Queyrat, which is a type of cancer occurring on the penis. Nearly all cases occur in uncircumcised males. We do not know what causes this condition to occur.
		White Patches Lichen sclerosus et atrophicus Lichen sclerosus et atrophicus (LSA) and it’s male counterpart, balanitis xerotica obliterans (BXO) presents as ivory or porcelain-white, smooth and atrophic areas on the genitalia. The cause is unknown, and it may be present for years before detection. Treatment is difficult and usually includes the use of potent topical or intralesional corticosteroids, as well as topical testosterone propionate ointment. Circumcision may relieve symptoms in males.
		Postinflammatory hypopigmentation This can follow any inflammatory disorder and does not require any specific treatment.
		Vitiligo These are sharply demarcated areas of depigmentation. Pigment is lacking in these areas.
		Skin Coloured Bumps Pearly penile papules These present as two or three rows of uniform, flesh-coloured papules running circumferentially around the corona. Onset is typically noted in the 20s and 30s. These things are not infectious and no treatment is required. They are often mistaken for warts.
		Vestibular papillomatosis These are also normal anatomical variants that occur on the mucous membrane of the introitus and labia minora and are often mistaken for warts. They are usually uniformly and symmetrically distributed, and are asymptomatic and require no treatment.
		Ectopic sebaceous glands (Fordyce spots) These are uniformly distributed, 1-2 mm flesh-coloured or yellowish papules that occur on the penile shaft as well as the labial surfaces. No treatment is required.

View

Genital herpes is usually diagnosed at the time of presentation, when a specimen from a blister or erosion is sent to the laboratory for viral culture, which is still the current gold standard for diagnosis of genital HSV infections.

Although the test is very accurate and reliable for diagnosis of the infection, a number of problems exist. The main problem is that patients often present when the lesions are healed, or when lesions are absent. The yield of positive cultures declines with duration of lesions.

Type-specific serological tests (TSST) for diagnosis of HSV infections would therefore offer doctors another means of diagnosis.

However, there are certain points that must be borne in mind.

•  HSV-1 is the usual cause of cold sores. Most infections are acquired during early childhood and it is estimated that more than 50% of adults have evidence of previous infection with this virus.

• Most genital infections are caused by HSV-2. However, the practice of oro-genital sex has meant that HSV-1 genital infections are occurring with increasing frequency. This factor may complicate interpretation of blood tests.

• Seroconversion may take up to 6 weeks. TSST may thus not be positive if done immediately after a first episode of genital herpes

These Guidelines are designed to be a concise and comprehensive reference manual by all doctors managing patients with STI. It is also a handy reference for paramedical personnel, medical students, and counsellors.

This third edition (2003) contains updated laboratory and treatment sections in all the chapters. For this update we referred to the 2002 STD Treatment Guidelines from the Centers of Disease Control and Prevention, the 2001 European STD Guidelines, local experience and knowledge. Some of these amendments include - new tests for Chlamydia infection and HSV; dropping of fluroquinolones as recommended treatment of gonorrhoea (close to 50% of isolates are resistant to this class of antibiotics); and classification of HPV treatment according to home or office-based therapies (hopefully reducing workload in clinics).

Information on key points of counselling and partner notification for these infections are also provided. These are integral to the complete management of patients with STI. A new section on screening of STI has also been added.

This publication is priced at $10 and is available from the DSC Clinic.

Three Times as Many People Living With HIV/AIDS in Middle East, West Asia Than Three Years Ago, WHO Reports [Feb 24, 2003]

The number of people living with HIV/AIDS in the Middle East and West Asia has more than tripled over the last three years, according to new figures released at a World Health Organization conference in Cairo, Egypt, last week, Agence France-Presse reports.

The figures indicate that 700,000 people are HIV-positive in the Eastern Mediterranean region -- which includes 18 countries, including Libya, Pakistan and Afghanistan -- compared with 220,000 HIV-positive people in the region in 1999. In addition, the proportion of HIV-positive people who are women nearly doubled in 2000 to 32% of the total number of cases, up from 17% in previous years.

Jihane Tawileh, head of the WHO HIV/AIDS program in the region, said that many of the countries do not have the equipment, staff and facilities to deal with the increasing number of people affected by the disease. She also called on officials in the region to include HIV/AIDS treatment in their free medical care programs, adding that curbing the spread of the disease is "not hopeless if there is adequate medicine." An unnamed conference attendee said that the numbers presented were "well below reality" and added that HIV/AIDS is a "real scourge" in some countries, including Libya, Djbouti and Sudan.

Some conference attendees said that people in the region do not seek treatment due to the stigma associated with the disease. Dr. Stewart Flavell, coordinator of the nongovernmental group People Living with AIDS, said, "There is an aura of shame that prevails in this region. You cannot fight a disease as long as you deny its existence" (Abboud, Agence France-Presse, 2/21).

Source: Kaiser Daily HIV/AIDS February 24, 2003.
Web: http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=16199

New Communication Tool Advances UNIFEM and UNAIDS Commitment to Reversing
Epidemic

UNITED NATIONS, New York - A new gender and HIV/AIDS web portal launched today, will provide researchers, policy-makers and practitioners access to cutting edge information at their fingertips. Developed by the United Nations Development Fund for Women (UNIFEM), in collaboration with the Joint United Nations Programme on HIV/AIDS (UNAIDS), the portal is a one-stop online resource center on the gender dimensions of the HIV/AIDS epidemic.

Globally, 50 per cent of adults living with HIV/AIDS are women. The epidemic disproportionately affects women and adolescent girls who are socially, culturally, biologically and economically more vulnerable, and who shoulder the burden of caring for the sick and dying.

UNIFEM's Executive Director, Noeleen Heyzer, in announcing the launch of the portal, stressed the importance of placing gender equality at the very core of the fight against HIV/AIDS. "We must do all we can to loosen and remove the grip of this terrible disease. I believe that one of the most powerful HIV vaccines available today is women's empowerment. By bringing knowledge and information to the global community, we are able to empower women. Women's empowerment is the key to reversing the epidemic."

Peter Piot, UNAIDS Executive Director, welcomed the creation of the web portal. "Women make up half the world's HIV epidemic, but bear a much higher proportion of its burden. They continue to provide most of the care for families and children, but are often last in line to receive life-saving care and information for themselves. This online resource center is a practical step forward by UNIFEM and UNAIDS together, designed to help improve the support for the millions of women around the world living with HIV and affected by the epidemic," he said.

The web portal will be a constantly evolving, multi-dimensional and dynamic virtual space that promotes understanding, knowledge-sharing, and action on HIV/AIDS as a gender and human rights issue. User-friendly, informative and interactive, the site offers research, training materials, surveys, advocacy tools, current news and opinion pieces by leading
experts, and women's stories from the field. Plans are also underway to house an experts database, which will serve as a technical and networking vehicle for national and global gender and HIV/AIDS specialists.

Please visit the gender and HIV/AIDS web portal at http://www.GenderandAIDS.org

"A gendered response is vital if HIV/AIDS is to be tackled effectively. This great resource will really help by providing people with the information and tools they need."

Hazel Reeves, manager of BRIDGE, a specialized gender and development service of the Institute of Development Studies

"This is a great interactive site. It's a place where I can connect with others working on the issues and get up-to-date information, ideas and good practices to support my work."

Sisonke Msimang, youth activist from South Africa

Some statistics:

* At the end of 2002, the number of people living with HIV/AIDS totaled 42 million. Of these 42 million, 38.6 million are adults - 19.4 million men and 19.2 million women.

* Of the 4.2 million newly-infected adults, 2.2 million are men and 2 million are women.

* AIDS deaths totaled 3.1 million in 2002, of which 2.5 million are adults - 1.2 million women and 1.3 million men.

* An estimated 3.5 million new infections occurred in Sub-Saharan Africa in 2002, and 2.4 million Africans died of the disease. In Asia, 7.2
million people are now living with HIV.

* Women make up 58% of HIV-positive adults in Sub-Saharan Africa, 55% in North Africa and the Middle East, and 50% in the Caribbean.

***
The United Nations Development Fund for Women (UNIFEM) works to promote women's empowerment, rights and gender equality worldwide.
UNIFEM,
304 East 45th Street,
15th floor, New York, NY 10017,
Tel: 212-906-6400
Web: http://www.unifem.undp.org

UNAIDS is the leading advocate for worldwide action against HIV/AIDS, bringing together eight United Nations organizations. It leads, strengthens and supports an expanded response to the epidemic that will prevent the spread of HIV, provide care and support for those infected and affected by the disease, reduce the vulnerability of individuals and
communities to HIV/AIDS, and alleviate the impact of the epidemic.

Condoms are regulated as medical devices and are subject to random sampling and testing by the Food and Drug Administration (FDA). Each latex condom manufactured in the United States is tested electronically for holes before packaging. Rates of condom breakage during sexual intercourse and withdrawal are low in the United States (i.e., approximately two broken condoms per 100 condoms used). Condom failure usually results from inconsistent or incorrect use rather than condom breakage."

The CDC Divisions of HIV/AIDS Prevention (DHAP)

1. Putting on two condoms will increase protection
Wearing two actually increases the friction between the condoms, making it easier for the condoms to break. Just one condom is sufficient.

2. You only need to put it on just before penetration
You should wear a condom even during foreplay. Dr Tan Hiok Hee, Deputy Head of the DSC Clinic, says there may be opportunities for a sexually transmitted disease to be passed on to your sex partner even before the penis enters the vagina.

3. Condoms can break easily
Condoms are classified as medical devices and are regulated by the United States Food and Drug Administration. During the manufacturing process, they are double-dipped in latex and undergo stringent quality control procedures. Breakage is usually due to incorrect usage rather than poor condom quality. Using oil-based lubricants can weaken latex, causing the condom to break. So avoid lubricants like Vaseline, suntan oil and even whipped cream. All can cause a hole in a condom.

In addition, condoms can be weakened by exposure to heat or sunlight or by age, or they can be torn by teeth or fingernails.

4. Condoms have holes in them and HIV can get through
While this may be true for natural membrane condoms, laboratory studies show that intact latex condoms provide a continuous barrier to micro-organisms, including HIV, as well as sperm.

5. Condoms reduce the pleasure felt by a man
Condoms are thin and do not prevent pleasure. If a couple is not using a condom, then they will be worrying about pregnancy and contracting STDs, which can lead to less pleasure than using a condom.