Solthis Newsletter E d i t o S u m m a r y Women health The GlobalFund: ofthereform at theheart GLOBAL HEALTH insitu support Solthis ECHOES FROM THE FIELD AIDS 2012 Washington CONFERENCE FEEDBACK HIV Cure SCIENTIFIC NEWS Viral Load andResistances FOCUS Fleutelot,Eric Sidaction Fogue Foguito, Positive-Generation INTERVIEW of outstanding grants, and most activities activities most and grants, outstanding of payment normal resumed not still has Fund Global the particular, In malaria. and culosis HIV, tuber against fight the for programs its of funding the with problems has also Mali going treatment isvital. care, especially those with HIV, for whom on- medical of need in those of all to course, of nowse out, go is thoughts Our compromised. riously region, in this difficult was already which needs, healthcare of Coverage Fasotania, Burkina andNiger. Malians have been fleeing this area to- Mauri of thousands many now months several For North. the in populations the of conditions deteriorating the to contribute all services healthcare of breakdown the and instability social the operation, military insecurity, impending an serious: is Mali in situation The Newsletter Issue 14 – December 2012 December – 14 Issue Universal  s i h t l o S 16-18 14-15 12-13 10-11 by capacity building forall by capacity treamentaccess to 5-9 2-4 - - quality treatmentquality inthehealthcare centers. high to access and testing diagnostic prove im- to 3 and 2 Bamako to support provided also has Solthis going. programs treatment quality high keep to authorities local with together working are who team, our by larly regions are and Mopti of Ségou visited regu- The mobilized. complete remains team Our for the localpopulations. programs treatment and diagnostic of support its continue to Mali in present main re will and remains Solthis this, all Despite force majeure. of case a of name the in hidden, remainmay pre this of war,all the of Because in women. gnant testing recommending messages of credibility the undermining months, few past the in lacking seriously been have ting tes- HIV Fordiagnostic blocked.areexample - -

SOLIDARITY is truly the first initial of Solthis. istrulythefirstinitial of SOLIDARITY ofthecountry.North the in conflict terrible the despite durable, be will HIV with those to provided care that the guarantee a are Mali in activities this’ - Sol dissuaded. be cannot we and workers, healthcare and patients to possible as close as remain to determined absolutely are We and conflicts. wars during necessary more even are ments families is also a moment of hope. These mo their and patients of Treatmentsupport and Pr Christine Katlama Chairman n - Interviews

Fogue Foguito, © Journal La Croix © IAS Eric Fleutelot, Executive Director of the Positive Generation, member of the 15% Coalition Deputy CEO international and spokesperson Cameroonian activist of the conflict against the AIDS, Fogue Foguito is also an activist of the right to Since the annual Conference on AIDS of this summer, Eric Fleutelot rises up in front of health for all. With the Coalition 15 %, it is threatened in its country by a trial for illegal organization of the mass media which speak more and more the « end of the AIDS ». manifestation.

You have been active in the Fight Against from membership fees, donations and ser- to healthcare [Abuja Declaration in 2001]. On Can we now speak of «the end of AIDS » funding cuts of the last two years are dange- nical platforms and facing shortages in both AIDS for many years. How did you become vices that we do. The rest of our funding came March 30 2011, the Coalition organized a de- the way it has been announced in the rous. Indeed in the fight against AIDS, which diagnostics and treatment. All of that is ter- committed to this cause? through the partnership response to calls for monstration in front of Parliament. Although media? is a disease that cannot be cured, the cost of ribly demotivating to the small number of hu- I have been politically active as long as I can proposals or joint implementation projects we filed for a permit to hold a public meeting For several months now, the media has cho- medical management is necessarily cumula- man resources dedicated to the fight against remember. I inherited this from my parents with partners. with the authorities, on the day of the protest, sen to take a shortcut from the innovative tive. To give 15 million people access to treat- HIV/AIDS. and even my grandparents: my grandmother The goal of PG is to help improve the living policemen in and out of uniform arrested us treatments available today to reduce the epi- ment, the way the Member states promised was one of first women in her village to fight conditions of patients with HIV/AIDS and several feet from Parliament, and brought and demic and the “end of AIDS”. I am outraged at the United Nations in June 2011, more mo- Although considerable progress has been against the single party; and my grandfather, high-risk populations. We are active in Came- held us at the police station under deplorable to hear anyone speaking of the “end of AIDs” ney is needed than for the 8 million existing made in access to treatment, the same cannot was a famous nationalist known for his moral roon by providing psychosocial support, mo- conditions because they claimed that the de- in 2012, when 1.7 million people have died patients. Thus more funds are necessary. The be said for discrimination and stigmatization. integrity. I come from a family where freedom bilizing the community and lobbying. monstration had been banned. Today, we are of AIDS and there were 2.2 million new infec- cost of disease management can only be re- HIV is a disease associated with significant of speech, justice and equality are sacred. We waiting for a court date. We had a court date tions in 2011. However you look at it, the end duced when the number of patients being stigmatization of HIV+ individuals, and added all learned very early to rebel when justice and Why did you create the Treatment Access on September 26, but the judge couldn’t find of AIDS is not a reality today, not in France or treated is high enough to reduce the number to this is the social marginalization of many of equality were not respected. As a child, my Watch (TAW) Observatory? the file and adjourned until December 26! The anywhere else in the world. of new infections, because of the preventive those who are infected because they are ho- father called me « little Sankara » (anti-impe- As a lobby we are often accused of not being government is trying to frighten us so that we AIDS cannot be cured today. Even in the effect of treatment. mosexuals, drug users, prostitutes etc. A prio- rialistic Burkinabian politician) because I was “scientific” enough. Therefore we created will stop speaking out. Why? There are several “rich” countries where access to testing, care And this is added to the fact that the cost of rity for all of those involved in the fight against the student spokesperson. grids to compile the information we obtained plausible reasons for this, but we cannot com- and treatment is known to be easier than in treatment is still too high. Why? First, because HIV/AIDS should be to work in an environ- At school, I heard about AIDS but I had no idea during our activities, ment on them here, because we countries with low incomes, the epidemic the cost of first line treatments is increasing: ment that respects the rights of the actors in of the consequences of the disease. At the on drug shortages, have been warned about that. We has not been contained. The epidemic is out guidelines recommend not using less ex- the fight as well as of the populations at high university [where he studied communication the quality of pa- will let justice decide. One thing is of control at our door in Eastern Europe. Eve- pensive single dose combination treatments risk of exposure to HIV. Unfortunately, this is and law] I began militate in defense of human tient reception etc. « We wonder why certain: what we are fighting against rywhere in Africa, progress made in the fight based on stavudine (140 dollars per year but not a top priority, in particular in countries in rights with the association Environnemental’ Our capacity for fol- they are going must affect certain obscure interests against HIV/AIDS is in danger. And finally, as with irreversible side effects). And beside this, Sub-Saharan Africa. Art: we discovered that students were being low-up/evaluation because otherwise why would they a person living with HIV, I think that you have more and more people living with HIV are tested for HIV without them knowing it and was very limited, so after us in this go after us this way? to be careful of the meaning of changing from first line Finally we cannot make the progress or ob- that the university refused to give them a we began working We have received the support of words… A world without AIDS to 2nd line treatment, be- tain the victory we hope for in a united fight room. This was the beginning of the fight and with 3SH in 20091 way » the US Embassy, from Ambassador is also a world without any cause of resistant viruses, against HIV/AIDS without the renewed com- Environnemental’Art became Positive-Gene- and a group of doc- Pepfar who is keeping a close eye on HIV+ individuals, and there are « To talk about and 2nd line therapies are mitment of political leaders. In the past, po- ration (PG). tors who wanted to our case, as well as from several Afri- a lot of us out there that would the end of three to four times more litical leaders led the fight against HIV/AIDS, study the impact of free HIV treatment. We can organizations, the European Union and like to stick around for a certain expensive than first line. but this is no longer true. Today it is more fre- What is the role of Positive Generation? created TAW together. several French associations2. We are deeply number of years…When you HIV/AIDS, is And what about 3rd line quently in the hands of technocrats, who may The name Positive Generation comes from The name is inspired directly from Human disappointed that France, which has historical speak of the end of AIDS, it is false » which can cost 100 times be competent, but whose political commit- the students who had dreams and even then, Rights Watch, because it is supposed to be an ties to Cameroon, and is the country of human factually false, but it’s also dan- more? Not to mention dia- ment is different. To mobilize people against were full of hope: we knew that we would be international observatory. Today, only Burkina rights, has not taken a position on this matter. gerous, or at least counterpro- gnostic testing and biologi- HIV/ AIDS, society must be mobilized, and in the HIV+ generation and that we would have Faso starts to use it. Despite the intimidation we will not give up, ductive when we are trying to cal and virological monito- particular political, artistic, community and to live with AIDS. But we didn’t want to use the As expected initial results showed the disas- because the risks, even if they are significant convince political authorities that they must ring whose cost has not yet decreased the way religious leaders who must show the way and word «HIV positive» it was too stigmatizing. trous state of HIV management. Of course can be overcome, and they are certainly less maintain or even increase their financial and treatment has. In this area, the priority must defend the values of this fight. Our slogan was: Think positive, Be positive the Minister and the CNLS contested the important than those of patients who have no human investment in the fight. be to lobby in the market to lower the cost of and Overcome. scientific legitimacy of these results even treatment. At the same time as the progress in the fight viral load testing and lymphocyte count. PG welcomes members who are HIV positive though we had informed them of the results n against AIDS is seriously in danger because and negative: there was no way we wanted ahead of time. And even if today we remain the leaders of both rich and poor countries Thus we find ourselves in engaged in a battle to create a group of HIV+ members only. A on speaking terms, they continue to take ac- are incapable of investing the sums necessary without enough money to continue ongoing 1. 3SH (Synergie des Sciences Sociales et Humaines) association group for patients only, that’s stigmatization tion without listening to us. For example no supporting research on questions of human and social to continue, you hear people talking about work and with the costs of medical treatment guaranteed! That is why we are not only ac- later than last week, we were not invited to development in Africa an HIV success story! Are they serious? What on the rise. In addition, we are working in 2. Several associations including Solthis have asked the French tive in patient networks. For example in 2003, the workshop on follow-up/evaluation that Ambassador to Cameroon to take measures to put pressure on success? The millions of deaths? In fact, if countries where trained healthcare human when the American association AWARE began they organized. And yet they are more than Cameroon authorities to have the charges dropped. there is any success story to talk about in the resources are too limited. Numerically too li- lobbying in Africa for laws to protect patients, happy to use our data when they are looking fight against AIDS, it is the incredible alliance mited to manage the 15 million people who PG was against it. For us, defending patient’s for funding. of patients, healthcare workers and research need to be treated, and there is also a pro- rights means respecting the universal rights of TAW is kept up to date daily by our “sentinels”. scientists who have managed to force public blem of efficacy: task shifting is only a solu- man. And we are also careful: when you get On Saturday we compile and analyze and on authorities to adapt the public response to tion if national programs invest in continuing rights, you have obligations. Monday we publish, and publish the results in the pandemic. But even then the fight against education for paramedical and psychosocial I was the President of PG from 2003 - 2008. our Newsletter. AIDS should not be called a success story, be- personnel. And task shifting must not result From 2008 - 2010, a Management committee cause it is fragile, even more so today. in lower quality services. Moreover, healthcare presided, before Alice Djenadek was elected Today the 15 % Coalition where you are an professionals may be isolated, in particular president. In 2010, thanks to support from the active member is being taken to court in What are the main challenges today in the from national programs and national coordi- European Union (EU), PG was restructured to your country. Why? fight against AIDS? nation bodies (such as the CCM) which often become more professional. Several managing The 15% Coalition is a collective of Cameroon There are many challenges facing the fight decide on protocols and make policies to bodies were created. I became the Executive healthcare and human rights associations. It against AIDS and they are basically the same scale up access to treatment etc. without their Director. In terms of financial resources, there gets its name from the promise made by the as those that we faced several years ago. input. Finally, healthcare workers too often is a minimum of self-financing, which comes government to contribute 15% of their GDP First, existing funding is insufficient and the find themselves working with deficient tech-

2 Solthis Newsletter • n°14 • December 2012 Solthis Newsletter • n°14 • December 2012 3 Focus : Viral Load and Resistances

Especially in African countries? tered on the patient and his/her family. More thing is inevitable about this story, but that on Viral Load and Resistances than anything, it should be based on the idea the contrary, by continuing to want change, We need to take a step back from all the pro- that things must be done with people, rather which is sometimes considered utopic even Importance of monitoring resistances to antiretroviral therapies in resource-limited countries gress we’ve made in the field, where the fight than for people. Decompartamentalization though it is close enough to touch, we can against HIV/AIDS has changed the destinies of of the actors in the fight against HIV/AIDS is make a durable change in our societies. millions of families. We need to look at what another solution to strengthen the healthcare n Resistance to ARVs: surveillance and biological monitoring more than ever essential we’ve done and ask ourselves a few questions! systems. Associations, which do a remarkable We have often helped build vertical services job, sometimes compensate for the gaps in The goal of Sidaction is for people living with HIV/AIDS. There is no the healthcare system. But this should not Expected increase in resistance to ARV in concerning Solthis’ activities in Africa are des- 2007-2010 conclude that the prevalence of to fight against AIDS by need to blame ourselves because there was no mean that public structures lose interest in the resource-limited countries cribed here. resistance to ARV is moderate, compared to other solution in countries where the health- fight against AIDS. In the same way, hospitals supporting programs Increased access to antiretroviral therapies only 18 % between 2004-2006, confirming the care systems were inexistent. However today that are specialized in HIV management must of scientific and medi- (ARV) in resource-limited countries means Prevalence of primary resistance overall tendency. In Africa, 18 countries per- with all the progress that has been made, it is also integrate the global approach to patient cal research as well as that more than 8 million patients with HIV A meta analysis of studies in the scientific li- formed this type of study including 6 in Cen- going to become important to increase sup- management, which has been shown to be ef- training, prevention were receiving treatment at the end of 2011, terature by WHO performed in countries with tral or Western Africa (Table 2). None of these port of capacity building in the healthcare sys- fective, either by working with associations or and mutual help pro- which multiplied by 26 the number of people low or middle incomes shows that the global ever showed a prevalence of more than 15%. being treated compared to 20031. rate of primary resistance has progressively in- tems and to gradually integrate other health- by developing psychosocial support services. grams to improve the quality of life, care care topics, especially those that affect people However, one of the expected consequences creased in the past few years to reach a peak If we focus specifically on the studies perfor- living with HIV, or high-risk populations. In What role should associations play in and support of people with HIV infection of this improved antiretroviral coverage in in 2009 with a prevalence of 6.6% (95% CI 5.1- med in Africa, the overall prevalence of re- this way, it is urgent to include the manage- meeting this challenge? and/or their families in France and the de- the developing countries, like in the deve- 8.3%) all classes of ARV combined (Table 1). sistance to non nucleoside reverse transcrip- ment of sexual and reproductive health in If we can be satisfied with existing progress it veloping countries. loped countries at the end of the 1990’s after tase inhibitors (NNRTIs) the key family in first HIV/AIDS programs. Even if it seems obvious, is only because we were constantly told that it tritherapies were introduced, is an increase in In the same way, if only studies that were line therapies, went from 1% (CI 95% : 0.3%- programs that integrate the fight against tu- was not possible for poor populations in poor resistance to ARV, in particular transmitted re- performed according to WHO guidelines are 2.1%) in 2003 to 6.4% (CI 95% : 1.3%-17.5%), berculosis should be ramped up, because countries to have access to high quality care sistance. Indeed the rate of resistance to ARV analyzed, 32% of those performed between which is more disturbing. This is this is the primary opportunistic infection in and sometimes difficult treatment regimens, is strongly associated with how long a popula- people living with HIV throughout Africa. It while our colleagues in these countries, sup- tion has had access to ARV and the rate of co- verage of ARV in a specific geographic area, as is not normal for a patient to have to consult ported by international solidarity and NGO’s Primary (or transmitted) resistance to ARV describes any phenotypic or geno- in one department for HIV and in another for from ‘rich’ countries have proven that it is shown by the prevalence of resistance around 2 typic resistance in the HIV virus when a treatment-naïve patient is first infected tuberculosis. Departments should be created possible. But today, the fight against AIDS is the world : where the patient is the center of focus and in danger. The feeling of urgency is no longer l 12.9 % in North America, with the virus. receives all the care and treatment s/he needs. there, even though mortality and the inci- l 10.9 % overall in Europe (including 10-12% Methodology of studies on primary resistance10. This would be more efficient for the patient dence of HIV remain high. The epidemic will in France [3]), and more economical for the healthcare sys- never really recede until people everywhere l 6.3 % in South America, l Selection criteria of patients must be rigorous. This means including patients tem. The management of coinfections and co- are mobilized again. This is a huge challenge l only 4.7% in Africa. who have not had prior exposure to ARV and were recently infected by HIV: morbidities, which are increasingly frequent, because it more or less means doing twice as patients under 25 years old, presenting, if possible with biological proof of re- WHO Strategy of follow-up and recent data must also be integrated into programs. In much in 4 or 5 years as we have already done cent HIV infection (seroconversion), while excluding if possible those with a fact, the medical services of tomorrow should in the past twelve years. It is an exciting chal- on resistance be based on a more human model of patient lenge. It will give families affected by HIV/AIDS In preparation for the expected increase in CD4 count of less than 500, in advanced stages of the disease (WHO 3 or 4) or management, which is more global and cen- hope for a new destiny. It will show that no- resistance in the developing countries, and women with a risk of prior exposure to ARV during pregnancy. to ensure the long term efficacy of ARV treat- ment, WHO has developed a strategy for the l The size of the study population should be as large as possible to reduce the prevention and monitoring of resistances confidence interval associated with observed prevalence to a minimum. based on: Collaboration with the review for international solidarity Difficulties and limitations l Monitoring early warning indicators (EWI), ALTERMONDES for a special report on AIDS. factors associated with the emergence of l It is difficult to respect the selection criteria in a situation where most patients Solthis as well as Sidaction, Aides, Solidarité Sida, ACT UP and other as- resistance in active patient files, which are are diagnosed and treated late. being monitored in pilot centers where an- sociations for the fight against AIDS, helped prepare a special dossier in tiretroviral treatment is being administered4. l The cost of drug-resistance genotyping is high, nearly 150 euros per patient. ALTERMONDES whose December issue was dedicated to HIV/AIDS. AL- l “Sentinel”, studies or investigations to moni- Thus most studies are performed in populations limited to 100 patients, resul- TERTMONDES is specifically dedicated to questions of international soli- tor resistance transmitted to newly infected ting in large confidence intervals that can bias interpretation of results. darity, sustainable development and human rights while giving voice to patients or primary resistance, and acquired members of civil society in the developing countries. resistances in patients being treated by ARV l Moreover very few laboratories in the developing countries have the equip- or secondary resistance. ment necessary to study drug resistances. “The end of AIDS, it’s possible, it’s coming tomorrow” can be heard eve- rywhere and made headlines in the media during the international HIV/ However the methodology of these viral resis- WHO guidelines AIDS conference in Washington last July. After thirty years of a ruthless tance studies must be rigorous and they are l Because of cost restrictions, the WHO working group on drug resistance deve- influenced by numerous difficulties that limit and exceptional fight, the international community finally has the means loped a so called “sequential sampling” method11 making it possible to reduce to end the epidemic. And yet a terrible question remains: will they give both their implementation and interpretation. Even if the number of studies is still insufficient the number of patients necessary to include in primary resistance studies to a themselves the means? and certain countries have never performed maximum of 47. In this issue, ALTERMONDES presents articles from associations, activists, any studies on resistance at all, in particular in l This method classifies resistance to each class of ARV into 3 levels correspon- and experts who confirm that yes, AIDS can be ended, but only under cer- Central and Western Africa, the landscape of resistance is now increasingly clear. ding to their prevalence rate: low (< 5 %), moderate (between 5% -15%) or tain conditions. high (>15%). Price of the review: 5 euros - www.altermondes.org The tendency reported in the most recent WHO report on resistance to ARV in July l WHO recommends performing this type of study every 2 years. 20121, and several recent studies in particular

4 Solthis Newsletter • n°14 • December 2012 Solthis Newsletter • n°14 • December 2012 5 Focus : Viral Load and Resistances

further supported by the results in Table 1. Estimated prevalence of HIV drug resistance among ARV–naive ted the prevalence of overall primary resis- Table 4. HIV drug resistance among people experiencing treatment failure at 12 months, treatment-naïve patients in Mali, with muta- individuals from the published literature, 2003–2010 tance to be 9.9% ([95% CI 6.9-12.9%], mainly by drug and drug class tions associated with resistance to etravirine to NNRTI. The second study in 54 patients (Y181),a potent NNRTI that is usually recom- in the Segou region showed a more mode- mended as second line therapy5 (Table 3). rate overall prevalence of primary resistance of 7.9% [8]. Although the precision of all of More specifically, there are no studies perfor- these studies is limited by the small size of the med according to WHO guidelines in countries study populations or the patient characteris- where Solthis has programs. One indepen- tics, they still confirm that the prevalence of dent study was performed jointly in 2009 in primary resistance is gradually increasing to a Guinea and Niger [6], which documented the “moderate” level. prevalence of primary resistance in these two countries. The estimated prevalences were Prevalence of secondary resistance 8.6% (95% CI 2.91-14.29%) in Guinea and 6.5% Because of the more complicated methodo- (95% CI 1.50-11.50%) in Niger. logy, there are fewer published studies on se- condary resistance. There are two specific ma- In Mali, at least two studies have been pu- jor difficulties: the large number of patients blished on primary resistance in the past few included in studies who are no longer being years. One performed in 2008 in 101 treat- followed-up after one year: nearly 25%; and ment-naïve patients from Bamako [7] estima- the difficulty of scientifically confirming the- rapeutic failure on a virological basis, when access to viral load testing is nearly inexistent. Table 2. WHO surveys of transmitted HIV drug resistance with results classifiable for at least one drug class Thus the WHO report only retained 9 indepen- dent studies on acquired resistance including 4,248 patients in 8 countries with 4 in Western Africa. Among the 573 patients with a treatment fai- lure (or 13% of included patients), 60% pre- sented with resistance to at least one class of drugs (NRTI: 55% ; NNRTI: 46%) of ARV. The remaining 40% have no resistance to ARV and treatment failure is due to other causes. Most studies on secondary resistance perfor- med with the WHO label were performed in Africa, but none in Western Africa. Once again, Tableau 3. Prevalence of drug resistance mutations in individuals included in WHO transmitted HIV drug resistance surveys, more than one quarter of the patients who 2004–2010 began treatment were no longer being fol- lowed a year later, for whatever cause: lost to Secondary (or acquired) resistance is the resistance that develops in patients follow-up (12.4%), transferred (6.1%) or sim- due to selective pressure from his/her ARV treatment. ply deceased (7.2%). Moreover, the very small On-treatment resistance to ARV appear in case of residual viral replication or viral percentage of patients who spontaneously load rebound which may be caused by many factors: the presence of existing mu- switched at 1 year confirmed the difficulty of tations which limit the efficacy of first line treatment, suboptimal dosages or drug identifying therapeutic failure when viral load interactions which reduce concentrations of ARV in the blood, poor observance testing is unavailable. Overall the rate of treatment success in pa- or other causes that prevent treatment from being taken regularly. tients receiving ARV and still being followed at one year was 76.6%. A resistance mutation Methodology of secondary resistance studies was only found in 70% of the patients with l Studies on secondary resistance are performed by definition in patients recei- treatment failures, which shows that a good ving ARV, in prospective studies or in occasional transversal cohorts. Usually the percentage of patients begin second line the- variable studied is the proportion of patients with a therapeutic failure and re- rapy who should not. sistance to ARV after 12 months of treatment. Even more disturbing data have been repor- ted in certain isolated studies. For example a recently published study in Difficulties 2008 in Togo [9] showed that the virological l These studies have the same cost constraints as studies on primary resistance, failure rate at one year was more than 30% which influence the size of the study populations and thus the precision of esti- 1.  WHO HIV Drug resistance report 2012 6. Charpentier C. and al. High prevalence of antiretroviral drug sectional survey for use in low resource settings. Antivir Ther in a cohort of 188 patients with resistance to mates. A minimum of 130 patients who have begun ARV treatment and have a 2. Frentz D, Boucher CA, van de Vijver DA. Temporal changes in the resistance among HIV-1-untreated patients in Guinea-Conakry 2008 ; 13 Suppl 2 :37-48. NNRTI in 80%. Once again certain profiles of epidemiology of transmission of drug-resistant HIV-1 across the and in Niger. Antivir Ther. 2011 ;16(3) :429-33. 11. Dagnra, A.Y., et al., High prevalence of HIV-1 drug resistance resistance genotype prior to beginning ARV treatment must be included. world. AIDS Reviews, 2012, 14 :17–27. 7. Haidara A, Chamberland A, Sylla M, Aboubacrine SA, Cissé among patients on first-line antiretroviral treatment in Lome, resistance are especially disturbing for usually 3. Chaix ML, Descamps D, Wirden M, Bocket L, Delaugerre C, M, Traore HA, Maiga MY, Tounkara A, Nguyen VK, Tremblay C. Togo. J Int AIDS Soc. 14 : p. 30. l Moreover, the main difficulty is the poor quality of treatment follow-up in cen- Tamalet C, Schneider V, Izopet J, Masquelier B, Rouzioux C, Meyer High level of primary drug resistance in Mali. HIV Med. 2010 Jul 12. Van Oosterhout JJ, Brown L, Weigel R, Kumwenda JJ, Mzinganjira recommended second line treatments, such L, Costagliola D ; ANRS AC11 Resistance Group ; Cohort PRIMO 1 ;11(6) :404-11. Epub 2010 Feb 8. D, Saukila N, Mhango B, Hartung T, Phiri S, Hosseinipour MC. as the K65R mutation, which creates resis- ters in resource limited countries as well as the difficulty of diagnosing thera- ANRS CO 6 ; FHDH ANRS CO4 Study Groups. Stable frequency 8. Transmitted antiretroviral drug resistance in newly hiv-infected Diagnosis of antiretroviral therapy failure in Malawi: poor tance to tenofovir, or resistance to etravirine. peutic failure, which is still rarely based on viral load testing, even though it of HIV-1 transmitted drug resistance in patients at the time and untreated patients in ségou and bamako, mali. Aids res hum performance of clinical and immunological WHO criteria. Trop of primary infection over 1996-2006 in France. AIDS. 2009 Mar ret. Med Int Health 2009; 14(8):856-61. Epub 2009 Jun 22. And yet the failure rate in therapeutic trials is known to be more reliable than the clinical and immunological criteria pro- 27 ;23(6) :717-24. 9. Bennett DE, Myatt M, Bertagnolio S, Sutherland D, Gilks CF. 13. Reynolds SJ, and al. Failure of immunologic criteria to and prospective studies performed with clini- 12-14 4. (Cf. Lettre de Solthis n°11, p 16-17). Recommendations for surveillance of transmitted HIV drug appropriately identify antiretroviral treatment failure in Uganda. posed by WHO . 5. Maïga Al, et coll. Resistance-associated mutations to etravirine resistance in countries scaling up antiretroviral treatment. Antivir AIDS 2009; 23(6):697-700. cal and virological follow-up were comparable (TMC-125) in antiretroviral naïve patients infected with Ther 2008 ; 13 Suppl 2 :25-36. 14. Mee P, Fielding KL, Charalambous S, Churchyard GJ, Grant AD. to those found in the developed countries; non-B HIV-1 subtypes. Antimicrob Agents Chemother. 2010 10. Myatt M and Bennett DE. A novel sequential sampling technique Evaluation of the WHO criteria for antiretroviral treatment failure Feb ;54(2) :728-33. for the surveillance of transmitted HIV drug resistance by cross- among adults in South Africa. AIDS 2008; 22(15):1971-7. nearly 10-15% at 12 months. Thus,

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easy access to viral load testing pro- ca, it is indispensable. Even though ARV have fective biological tool: viral load testing. Even bably improves the diagnosis of virological been available in certain areas for the past ten if different strategies are possible, all of the ac- New strategies sustained by UNITAID failures and makes it possible to change to se- years, information remains limited but clearly tors working in the field of HIV seem to agree cond line therapy early, limiting the accumu- shows that the rate of resistance is increasing, to this approach, such as UNITAID, which is lation of resistances that may negatively affect in particular to NNRTI and NRTI, key molecules developing several approaches for the deve- the efficacy of second line therapy. in first line therapies. We must increase our loping countries. n understanding of resistance, in particular on- In 2009, for the first time, UNITAID In conclusion although monitoring of trans- treatment acquired resistance; but we must Dr Rémi Lefrançois published a request for proposals to mitted and acquired resistance to ARV is not especially improve follow-up in patients on Scientific Coordinator develop access to biological testing easy in resource-limited countries such as Afri- treatment by providing access to the most ef- devices (CD4 count, viral load and PCR for early diagnosis in newborns) in low income countries. What are the goals of this request for proposals? In response to a real need in the regions of resource limited countries, the Board of Di- The expert’s point of view – Pr Vincent Calvez, Department of Virology, rectors of UNITAID has decided to support projects associated with CD4 counts, as well Pitié-Salpêtrière Hospital (University Paris VI) as viral load testing and early PCR diagnostics in infants, nearer to treatment centers. Indeed: Why are primary and secondary resistance fore incorrect to believe that the same thing 2 NRTI + 1 PI. The results show the same vi- l Only 9% of patients have access to viral load studies needed? would not happen in Africa that happened rological response rate in both arms. On the testing in the outlying regions of limited re- First with HIV, as with all infectious diseases, elsewhere just because treatment begins other hand, with first line PI the virological source countries regular epidemiological follow-up is necessa- directly with tritherapy. It is impossible to response is higher than with NNRTI. NRTI are l The cost of viral load testing is very high: 100 000 - 225 000 dollars for a machine and 10 © UNITAID ry to identify viral resistance to the anti-infec- know today if the rate of primary resistance very effective in countries in which patient Zambia, 2011 tious agents used. These are good practices will increase further. follow-up is adequate because they are well -70 dollars for a test; in medicine and just because it is in Western Data on secondary resistance are also very tolerated and inexpensive with a long half- The use of these devices is complex and re- who have access to essential diagnostics and Africa, does not mean they should not be fol- alarming. According to several studies, the life Thus, shouldn’t the treatment strategy quires both a specialized infrastructure and increase the number of healthcare centers lowed. rate of virological failure is approximately be changed? Obviously this is a complex specifically trained technicians. where these devices are available. Second, in the fight against HIV, investigation 15%. That is fairly normal and these results can discussion that should take into account the of primary and secondary resistance is essen- even be considered good. The problem is the price of treatment… Several types of gui- This commitment to support innovative dia- 2. Médecins Sans Frontières (MSF). The MSF tial. However, if a priority had to be given to lost to follow-up cohort. Certain studies have delines are needed: for countries with ge- gnostic technologies is the fruit of a long project received 28.7 million dollars of fun- the two types of studies, studies on secondary a high rate of lost to follow-up, which should neralized access to viral load, for those with process of expert research begun in 2009. In ding from UNITAID. The goal is to make CD4 resistance are probably more important. Why? be interpreted with caution, because this is partial access and for those who only have 2011, UNITAID obtained several general ana- counts available at the treatment centers and Because primary resistance is very difficult to difficult to evaluate correctly. Patients who clinical criteria. lyses including one on the diagnosis of HIV/ 15 to develop viral load testing in decentralized study in Africa where patients are diagnosed escape from first line combinations develop AIDS: Diagnostic Technology Landscape . healthcare centers. About UNITAID late. These studies analyze the resistance of numerous resistance mutations: 15 % in the What strategies seem to be best adapted These reports describe/plan on the develop- Seven countries are concerned by this project: UNITAID uses innovative approaches to viruses that infected a person 4 or 5 years ago. first year and 10 % the next year. So after 2-3 to improve access to viral load? ? ment and imminent marketing of simple, ef- South Africa, Lesotho, Malawi, Mozambique, increase access to treatments and dia- WHO has tried to establish a strategy based years 25 - 30 % of these patients have signi- In terms of access strategies, I do not have one fective accessible diagnostic tools- closer to Uganda, Swaziland and Zimbabwe. gnostics for HIV/AIDS, malaria and tu- on a study of 50 patients under very complex ficant resistance to first line therapies. These single approach. Several approaches must be treatment centers. With its request for propo- This project shows the feasibility and cost- berculosis in low-income countries. It is conditions, in which resistance was measured results are predictable. But what is very alar- taken depending upon the type of hospital: sals, UNITAID hopes to play a role in influen- effectiveness, of viral load and CD4 counting the first global health initiative to work at a very early stage. To my knowledge, very ming are the treatment failures from second l Commercial kits have several advantages: cing the market of biological monitoring tools in isolated, rural areas to create a market for through market interventions to make few countries have managed to perform this line therapies with protease inhibitors (PI). In- they are easy to use, automated (no need for in order to increase access to a large line of these products. life-saving products better and more af- type of study and very often, they have not deed the genetic barrier to resistance of boos- complex formulas) and cost effective. A well- innovative products. According to MSF, more than 200 000 patients fordable. The bulk of UNITAID’s resources been reproduced. ted PI is considered to very high. However equipped reference laboratory could test come from a small levy on airline tickets Several strategies have been chosen in the are going to benefit from viral load testing My team performed a study for several years this is only true under optimal conditions of 15000 patients per year. The price must be in several countries, while the rest is pro- developing countries, including open during the three years of the project. MSF es- in Mali in patients with severe immune defi- follow-up and observance, which are difficult negotiated although it decreases regularly. vided primarily by multi-year contribu- platforms - OPP ERA - which are supported timated that 16 000 patients will change from ciencies but who were going to begin treat- to conform to in these countries. As a result l Generic kits (“Open platform”). Their use is tions from governments. This long-term by Solthis. Can you explain the main 1st line treatment to 2nd line treatment after ment, which was very interesting from a cli- the rate of resistance to PI after second line more complex and requires extensive trai- and predictable stream of funding allows principles of each of these? diagnosis of a virological failure. nical point of view. It is just as important to therapy is very high as shown by the results ning for technicians. UNITAID to provide incentives for manu- understand the virus that infected a person 3 of the study by A. Maïga in Mali. Even with a l Points-of-care (portable viral load testing). In 2012, the Board of Directors of UNITAID 3. France Expertise Internationale Opp-Era: facturers to supply quality public health or 4 years ago that is going to be treated as molecule such as lopinavir, which is a potent These are obviously very interesting for pa- approved 3 new projects on complementary The goal is to improve access to viral load tes- products at a reduced price and bring to understand the actual circulating virus. I antiviral drug, the rate of resistance increases tients in outlying regions. But these have not innovative strategies: ting in four target countries (Burundi, Came- new formulations tomarket. would also say that the figures produced by under poor conditions of use. yet been extensively developed. roon, Ivory Coast and Guinea). By promoting these studies are “baseline figures”. They cor- 1. Clinton Health Access Initiative and the OPP (Open Polyvalent Platform) model, respond to the virus that infected people 3/4 How can the rate of secondary resistances These strategies could be complementary UNICEF. The Board of UNITAID granted 20 the goal of the first phase is to change the years ago, which are viruses that are generally be reduced? and not opposed. million dollars to this project, whose goal is market dynamics of viral load technologies less resistant than those circulating several l Ideally viral load testing should be genera- n to accelerate access to innovative biological to improve follow-up of patients with HIV at years later. lized as much as possible. It is important to follow-up tools for HIV/AIDS at the treatment a reduced price and on a larger scale in target remember that once the patient is being centers (CD4, viral load and Early diagnosis in countries. UNITAID has granted a maximum of The rate of resistances seems to be treated, spending money on measuring the infants) in Ethiopia, Kenya, Malawi, Mozam- 2.4 million dollars to implement phase 1 of the increasing in the developing countries. Is CD4 count is useless, it is more important to bique, Uganda, Tanzania and Zimbabwe. project. n this expected and are these figures make sure that viremia is undetectable. The intervention of UNITAID in this market alarming? l First line treatment strategies must also be should increase the demand, lower the prices l When we began studies in Mali in 2002 there reconsidered. At the CROI, Pr Nathan Clu- of products and introduce a large line of in- were zero primary resistances. Since then meck presented a randomized trial perfor- novative products by simplifying the rules for the rate has increased. In my opinion, we med in the Congo which compared first acquisition and work with developers. These could reach rates of 10 - 15 %. It was there- line treatment with 2 NRTI + 1 NNRTI versus actions will increase the number of clients

8 Solthis Newsletter • n°14 • December 2012 Solthis Newsletter • n°14 • December 2012 9 Pr Brigitte Autran Pitié-Salpêtrière Scientific news: A cure Hospital, Inserm UMR-S 945, Paris VI Pr Christine Katlama Pitié-Salpêtrière Hospital, Inserm Potential strategies to reduce HIV reservoirs Eradication or remission of HIV: What hope for tomorrow? The term “HIV cure” refers to two entities: U943, Paris VI CD8 In July 2012 at the World Aids Conference the world of research dared to pronounce Pr Christine Rouzioux Maraviroc 1. Eradication of HIV is defined as the di- CD4 Laboratory of Virology, An1-­‐inflammatory drugs the word “cure” as they launched the International AIDS Society Program: Towards an -­‐ Sta1ns Gold salts sappearance of all infectious viral particles Cellular Immunity Necker Hospital, -­‐ Chlorochin OH-­‐ and the elimination of all latent infected Immune Interven1on HIV Cure. The hopes of the scientific community are now focused on « reservoirs ». An EA 3620 Université Massive CD4 T-­‐cell deple1on ARV Interven1on Bacterial transloca1on -­‐ An1-­‐HIV vaccine cells in chronically infected patients. The -­‐ Intensifica1on update on the progress of treatment and on new directions in research. Paris Descartes -­‐ IL7 only example of this at present is the “patient Systemic Inflamma1on -­‐ Nevirapine in Berlin” in whom no virus or infected cells Pre-­‐Probio1cs could be detected after chemotherapy for leukemia and two bone grafts from a donor Viral Co-­‐ Immune Residual A decade ago, the HIV/AIDS epidemic was l if treatment is stopped, whose immune cells were deficient in the Infec1ons one of the greatest threats to human health. HIV starts replicating CCR5 receptor. The case of this patient is fun- Ac+va+on Replica+on Today, 35 million people live with this disease again, that is, the virus damental for the proof of concept of a cure. An1viral drugs including two thirds in sub-Saharan Africa. multiplies from its reser- On the other hand the procedure used can- Gene therapy It has killed 25 million people since the first voir cells; not be reproduced on a large scale due to the l cases were identified in 1981, and 2.7 million ARVs are associated with high risks associated with the treatment. CD4 DC Quiescent T cells ac1va1on people continue to be infected every year. co-morbidities, especial- HIV Reservoirs -­‐ IL7 The arrival of antiretroviral (ARV) therapy ly as patients age such as 2. The term remission or “Functional Cure” An1-­‐co-­‐s1mulatory molecules Latency transformed the prognosis of HIV with a mas- metabolic disorders due is based on the well known notion in onco- -­‐ an1 PD1 / an1 PDL1 Pre/post-­‐transcrip1onal -­‐ an1-­‐CTLA4 factors disrup1on sive reduction in mortality as well as in the to protease inhibitors or logy describing a disease that is in remis- -­‐ an1-­‐CD137 -­‐ HDACi comorbidities associated with HIV. certain non-nucleoside sion, or without clinical signs, which does -­‐ HMBA methila1on inhibitors Antiretroviral treatment: an undeniable revo- reverse transcriptase not progress, but in which the HIV has not lution inhibitors (NNRTIs) (efa- disappeared either. The virus persists in the Potential strategies to reduce HIV reservoirs The development of new drugs that are more virenz), bone disorders, organism at a very low rate of replication and more effective, increasingly well tolera- cardiovascular risk… ; (less than 400 copies/ml) with no clinically ted and simple to take on a daily basis has re- l ARVs are expensive: ap- significant effects after ARV treatment is dis- 1. Targeting residual replication. DNA (HDAC). The use of these activators is sulted in a therapeutic success rate of nearly proximately 1000 euros continued. Two patient populations fall into The sources of persistent HIV-1 viremia in pa- nevertheless complex and potentially dan- 90% in patients receiving ARV treatment. In per month in the deve- this category: tients on treatment have not yet been com- gerous because they are non-specific for the the past few years the indications for treat- loped countries and 100 - l patients called Elite Controllers who have pletely determined, but could be the result virus. In other words these activators could ment of HIV have been extended: from the 500 euros in the undeve- an undetectable RNA viral load in plasma of cycles during residual viral replication and/ reveal a cancerogenic process. Several HDAC clinically symptomatic stage to a non-symp- loped countries. The necessity of taking this lymphocytes and monocytes/macrophages, without treatment. This population is rare or of reactivation of viral expression in latent inhibitors are or were being evaluated: val- tomatic stage with clear immune deficiency treatment for life explains why the financial which are key cells in the immune system. (0.3 - 0.5% of the HIV+ population) and has infected cells. Several factors could be the proic acid was shown to be ineffective, while and fewer than 350 CD4/mm3. Little by little, burden of ARV has begun to affect health- CD4 memory T cells are the most highly in- a specific genetic profile with over repre- cause: insufficient absorption of antiretrovi- vorinostat (SAHA) seems more promising. these indications have been extended to be care economies throughout the world; fected and are the principle reservoir. Viral sentation of HLA-B27 and B57 and a low rals in the deep tissues and non-optimal pe- closer to the moment when the diagnosis of l ARVs are only administered to 6 million persistence is linked to the fact that these DNA reservoir; netration in infected cells, homeostatic proli- Conclusion infection is confirmed. people worldwide today which only repre- cells have a lifespan lasting from several days l another group recently described patients feration of CD4 memory T lymphocytes (also Basic research to identify the mechanisms, At present in certain countries such as France, sents 40% of the patients in need. Exten- to several months and preserve the capacity with a profile that corresponds more to the resulting in the proliferation of infected cells), find molecules that can knock the virus out ARV treatment is recommended from 500 ding the indications would require an even to proliferate while still producing the virus idea of disease remission, Post Treatment a proinflammatory environment, the very of the organism and clinical research to test CD4/mm3. Recently the International Aids greater effort. as soon as they are infected. This reservoir is Controllers. The VISCONTI study described high density of T CD4 cells or the presence them have all become a necessity in the fight Society (IAS) and the North American health- found throughout the entire organism be- 15 patients who were chronically infected of mature dendritic cells that favor cell to cell against HIV. This very ambitious goal is even care authorities (Department of Health and Research on the eradication or remission cause CD4 memory T cells are constantly cir- with HIV, treated for 3 months or more after HIV transmission. more difficult because for the moment, there Human Services - DHSS) have recommended of HIV: a major challenge. Why can’t culating in the lymph glands, the spleen and a primary infection for a median of 5 years, is no way to knock out a retrovirus that has initiating ARV treatment whatever the num- existing treatments eradicate HIV? lymphoid tissues, which are also associated in whom interruption of ARV treatment did 2. On the contrary, inhibiting cell activa- integrated the nucleus of a cell. And yet it is ber of CD4 for several reasons: Three main hypotheses explain why ARV can- with the mucous glands, while macrophages not result in renewed viral replication, af- tion and residual inflammation to inhibit only with the same sort of scientific, clinical l Treatment reduces morbidity-mortality as- not eradicate HIV. reside in non-lymphoid tissue. The size of the ter a median of 75 months. These patients residual replication and political investment that was necessary sociated with HIV. The biological progres- l viral integration, latency and persistence in reservoir can be estimated in each patient by are characterized by an excellent immune The results of the first trials with anti-in- to develop antiretroviral tritherapies, that we sion of the disease can be controlled and reservoir cells which occurs early in the in- quantifying the number of infected cells in response with a median CD4 count of 845 flammatories such as statins or hydroxy- will one day be able to respond – positively or deterioration of the immune system can be fection, which is not controlled by ARV, and the blood by measuring HIV-DNA. CD4/mm3, a CD4/CD8 of 1.49, a nadir CD4 chloroquine were not conclusive. The use of negatively – to the inevitable question asked prevented, which is also responsible for se- which can begin replicating again as soon Thanks to cohort studies the viral reservoir of 505 mm3, a very small HIV-DNA reser- stronger anti-inflammatories, or even immu- by HIV+ patients: ‘Doctor when will I get rid of veral secondary comorbidities not directly as treatment is stopped; process has been described during the di- voir (approximately 1.5 log 10 per million nosuppressive drugs is being considered. the virus?’ The question of treating reservoirs linked to HIV such as the development of l persistent low levels of viral replication sease. The highest DNA levels were found cells). Moreover, these patients do not have does not only concern patients in the deve- cancers and an increased cardiovascular whose causes are still not well known, but in primary infection, and the lowest in Elite the same favorable genetic profile as Elite 3. Attacking virus latency loped countries. It is easy to imagine that this risk. which may include irregular or insufficient Controllers. Treatment begun during primary Controllers. Other studies have confirmed There are several possible approaches. type of treatment will be at least as useful in absorption and circulation of treatment in infection reduces the reservoir to very low le- the possibility of going without treatment l Activate latent cells to promote viral expres- the developing countries, by drastically redu- l Treatment massively reduces (>90%) the deep tissue and in lymphoid tissue; vels. Thus the reservoir represents the quan- for several months and without replication sion so that it can be secondarily controlled cing costs and the duration of treatment and risk of transmission from HIV+ individuals l immune activation and persistent inflam- tity of virus the organism must control. The in patients treated very early with a small by ARV. There are several activation pa- by reversing the risk of progression of the on treatment to HIV- individuals. mation despite maximum control of viral earlier the infection is treated the greater the reservoir. thways of the cell such as JAK-STAT activa- epidemic. n Although ARV treatment has progressed replication, favoring the production of a reduction in the viral reservoir. ted by IL-7 or activation of the NF-kB pa- considerably and has become more effective, low levels of viral replication. How can the HIV reservoir be reduced? thway via prostatine or TNF –α. simpler to administer, (with effective trithe- Functional cure of HIV infection or There are three areas of research based on l Wake up the latent virus rapies now available in one pill once a day) What is the viral reservoir? eradication of HIV? the mulitfactorial mechanisms involved in Latency is maintained by various mecha- better tolerated, and more widely distributed During the viral cycle, the virus that has pe- For all the reasons mentioned above, clinical the process. These approaches should be nisms: either by blockage of the signalization worldwide, in 2011: netrated the cell integrates into the nucleus research has focused on eradicating the infec- combined. Basic research studies are still cascades described above or by epigenetic l existing treatment cannot eradicate HIV and remains quiescent, silent, and perfectly tion, or more realistically in the past few years, needed. mechanisms protecting chromatin such as from the cells that harbor it (these are cal- hidden from the immune system and from there has been renewed interest in the scien- histone methylation or desacetylation of led reservoirs); ARV. The main cells that are infected are CD4 tific community in the idea of HIV remission.

10 Solthis Newsletter • n°14 • December 2012 Solthis Newsletter • n°14 • December 2012 11 Etienne Guillard Pharmacy Manager Conference Feedback

tic testing, prevention and management of New Treatments - AIDS 2012 cryptococcus20. The strategy was based on systematic testing in all high-risk patients The 2012 Annual World Aids Conference was held from July 19-22. Organized by the International Aids (CD4<100/mm3) with rapid test strip testing Society, the meeting was held in the USA for the first time in 19 years since the ban preventing HIV positive the detection of the Cryptococcus antigen individuals from entering the country was lifted. Etienne Guillard, who was present at the Conference has (CRAG lateral flow assay, a method that has been validated by the FDA21) and preventive selected the main informations on new treatments presented there. treatment with fluconazole 400mg taken once a day (algorithm – table). 13,14 This integration of routine screening is similar countries . The goal of this study is to pre- to what was done in Uganda and published vent fragmentation of the market into small a little earlier this year22, and which showed quantities to allow more rapid purchases at that this strategy is very cost effective, repre- more interesting prices and to limit the risk of senting for Uganda 1.57 dollars per DALY (Di- shortages and losses. sability-Adjusted Life Year).

In Adults – new integrase inhibitors and showing that neuropathies in 1/4 children7 Tuberculosis - new treatments The question of which treatment is best adap- booster were due to the limited therapeutic options in There was important news on antituberculo- ted to low-income countries is recurrent. Numerous studies were performed on the this population. The use of mostly stavudine- sis treatment with new molecules and thera- Fluconazole 1200 mg is the most frequently main available ARV molecules. Complementa- based treatment (D4T) at present is a remin- peutic regimens. These results were particu- prescribed regimen. A poster from a Ugandan ry data were presented in adults in particular der of how important it is to develop novel larly encouraging because of the presence of team23 presented a cost-effective analysis of for the class of integrase inhibitors. pediatric therapeutics for resources limited multi-drug resistant tuberculosis (TB) in nu- different treatments, in particular for treat- Figure 2. Cost effectiveness of cryptococcal induction therapies Thus the 5 year results on raltgravir in the countries. merous countries. ment induction. This study, published since STARTMRK and BENCHMRK studies confirmed The FDA has extended the indications for a Thus one new molecule PA-824, was admi- on PLoS24, showed that induction of treat- the very good efficacy and tolerability profile certain number of ARV to children based on nistered in an original regimen with moxi- ment with amphotericine B for 7 days then tors and protease inhibitors are the cause of clinically observable with antimalarial drugs. floxacine and pyrazinamide in a randomized of this molecule both in treatment-naïve pa- recent results: tenofovir, raltegravir, darunavir, 15 fluconazole 1200 mg is the most cost-effective numerous drug interactions because of their With the combinations of AZT+3TC+efavirenz tients and patients with resistances to three fosamprenavir8. AIDS 2012 was an occasion to 14-day study . Antibacterial activity with this regimen, as shown in the figure above. Never- effect on cytochromes P450. One satellite ses- (EFV) and artemether/lumefantrine, concen- classes of drugs1,2. present new data on this topic, in particular on regimen was greater than in the other treat- theless amphotericine B is fairly expensive. sion26 organized by the HIV drug interaction trations of artemether, dihydroArtemether Moreover, the results of 96 weeks of elvitegra- integrase inhibitors, for example preliminary ment arms, an eliminated 99% of the tuber- Also this implies a committment from interna- team27 discussed the main drug interactions. and lumefantrine were reduced by 77%, 75% vir3 confirmed those for 48 weeks: the non-in- results from the IMPAACT 1093 study on the culosis bacilli with relatively good tolerance. tional funding agencies so that it will become Although information on antituberculosis and 55% respectively. The combination with feriority of raltegravir, evaluated according to use of dolutegravir in adolescents9. Although Moreover, this regimen was effective in mul- part of free treatment programs.25 drugs is well documented and generally takes protease inhibitors was just as critical with a virological (48% vs 45%) and immunological the results are preliminary and were performed ti-drug resistant and extremely resistant TB. into account therapeutic regimens adapted significant increase in plasma concentrations results (205 vs 195 CD4/mm3), as well as good in a limited number of subjects, they showed Finally, initial results suggest that drug inte- Drug interactions – care must be taken to simultaneous HIV/TB treatment, this is less of up to 4 times for quinine and 386% for lu- tolerance to daily administration of the drug. the similar pharmacokinetic profile between ractions will be less important than with usual with concomitant administration of ARV true for antimalarial drugs. One presentation mefantrine (risks of potential toxicity). On the An important presentation of the SPRING 2 adults and adolescents with a daily dose of antituberculosis treatments. and antimalarial drugs during this session and a poster28 showed other hand there was a decrease of 43% for 4 Sutezoilid (PNU-100480) was presented in the study compared dolutegravir to raltegravir at 50mg, good tolerance and virological efficacy 16 Non nucleoside reverse transcriptase inhibi- that these interactions were significant and artemether. 48 weeks. These results showed the non-infe- with at least a one log decrease in viral load in late breaker session . Its use for 14 days in 25 Because of the importance of these interac- riority of dolutegravir, both for virological suc- all subjects after 4 weeks (median 2.8 log). patients resulted in a significant reduction in tions and the prescription context in Africa, it cess (88% vs 85%), immunological response The results of the CHAPAS2 study on the number of tuberculosis bacilli in sputum is urgent to draft guidelines to help healthcare (increase in CD4 from 230/mm3 in each arm) lopinavir/r microgranules were presented11 with a good tolerance profile. The lack of effect professionals manage these situations. n and the tolerance profile. Nevertheless do- during the satellite session of the Internatio- of this molecule on cytochrome P450 3A4 sug- lutegravir has the advantage of being taken nal AIDS Society-Industry Liaison Forum (IAS- gests that it will cause fewer drug interactions. once a day. ILF) and Drugs for Neglected Diseases initia- Moreover, the use of isoniazide as preventive Finally new results confirmed the interest of tive (DNDi)10. This form is interesting (even if it treatment (IPT) in a randomized double blind 20. Satellite session TUSA08 placebo study in South Africa for 12 months 21. http ://www.immy.com/ cobicistat as a booster. The administration of is not perfect) because of the palatability. On 22. Rajasingham R. et al. Integrating Cryptococcal Antigen atazanavir+cobicistat was shown to be non- the basis of these results DNDi and the CIPLA confirmed the efficacy of this molecule. The in- Screening and Pre-Emptive Treatment into Routine HIV Care JAIDS : cidence of TB went from 3.6 (CI 95%: 2.8-4.7) to 15 April 2012 - Volume 59 - Issue 5 - p e85–e91 inferior and with a similar tolerance profile laboratory announced the development of a 23. Poster Exhibition WEPE028. 2.3 (CI 95: 1.6-3.1) in the IPT arm for 100 patient 24. Rajasingham R et al. Cryptococcal Meningitis Treatment and efficacy to the atazanavir+ritonavir regi- combination of 4 ARV in 1 packet of microgra- 17 men5. nules with zidovudine/lamivudine (AZT/3TC) years (p=0.026) . Based on the results obtai- Strategies in Resource-Limited Settings : A Cost-Effectiveness ned with IPT, Family Health International (FHI) Analysis. (2012) PLoS Med 9(9) : e1001316. doi :10.1371/journal. At the end of August 2012, two molecules or abacavir/lamivudine (ABC/3TC) and lopina- pmed.1001316 12 took advantage of the conference to present 25. http ://preventcrypto.org/ mentioned received marketing approval from vir/ritonavir (LPV/RTV) . 18 26. Satellite session SUSA34 on line courses on its use . The i-TECH course 27. http ://www.hiv-druginteractions.org/ the Food and Drug Administration (FDA) in the At the same time, although identifying new 19 United States in the QUAD (Stribild®: tenofovir pediatric ARV forms is essential to improving on this subject should also be mentioned . 28. Poster Exhibition TUPE054 + emtricitabine + elvitegravir + cobicistat)6. management in children, these many new forms make purchasing and stock manage- Cryptococcus – what type of testing and Pediatrics - new treatments in the pipeline ment more difficult. The team from the Clin- what treatment? One of the major challenges at present is to ton Foundation presented its work in colla- Several sessions discussed cryptococcus, in obtain new treatments adapted to children. boration with WHO and UNICEF to rationalize particular a satellite session on the experience A South African team presented a study the lists of pediatric ARV in several African in South Africa on scaling up the diagnos-

1. Poster abstract LBPE19. 9. Oral abstract TUAB0203. Geneva ; Mumbai, July 20, 2012 2. Poster abstract TUPE025. 10. International AIDS Society-Industry Liaison Forum (IAS-ILF) and 13. Satellite session SUSA61 3. Oral abstract TUAB0105 Drugs for Neglected Diseases initiative (DNDi), Catching children 14. Poster Exhibition THPE673 4. Late breaker oral presentation THLBB04. before they fall : addressing the urgent drug development needs 15. Oral Abstract MOAB0305 5. Oral abstract TUAB0103. of children living with HIV. 16. Oral Abstract THLBB02. 6. http ://www.fda.gov/ForConsumers/ByAudience/ 11. Oral late breaker LB_08 - http ://regist2.virology-education. 17. Abstract THLBB03. ForPatientAdvocates/HIVandAIDSActivities/ucm317204.htm com/2012/4HIVped/docs/21_Keishanyu.pdf 18. http ://www.fhi360.org/training/en/ipt/index.html 7. Oral abstract MOAB0205. 12. DNDi and Cipla, DNDi and Cipla to develop 4-in-1 pediatric 19. http ://www.tbpreventiontoolkit.org/ 8. Lettre de Solthis – n°13 – Juin 2012 antiretroviral drug combination, press release, Washington DC ; Figure 1. Algorithm for CRAG screening upon entry into HIV care

12 Solthis Newsletter • n°14 • December 2012 Solthis Newsletter • n°14 • December 2012 13 Sophie Calmettes Director of Echoes from the field Operations Charlotte Dézé Capacity Building Manager management of co-infection. Certain 2. The goal to complete a “pilot” of our Capacity building : Understanding Solthis support in situ Hannah Yous services received material or unde- approach to structure on-site support Quality project rwent renovations, and during the first Number of patients in nine centers was ambitious and took For two years, the support provided by Solthis teams to healthcare centers, which is Leader Guinea team meetings, the participating de- initiating treatments more time than planned. It was neces- one of the association’s key intervention strategies, has been thoroughly assessed. partments discussed the data presen- Number of patients sary to take into account the time ne- Structuring the approach, reflecting upon methodologies, and experimentation are on- ted in their activity reports (the number lost to follow-up cessary to appropriate this approach by of patients who were co-infected but Number of patients the partners, but also by Solthis teams. going : spotlight on the intervention in Guinea. receiving treatment, for example). referred to other center However, this also showed that the dif- To ensure improvement in individual Number of death ficulties encountered were not always patients Since it was created in 2003, Solthis’ goal has AIDS in low-income countries. national authorities during a regional feed- skills, Solthis is developing a post-trai- inherent to the approach, and made it been capacity building for the healthcare sys- Solthis has been developing this methodo- back workshop. Healthcare center directors ning follow-up for healthcare profes- Number of patients possible to begin identifying the “keys follow-up tems in the countries where it intervenes, so logy for two years by offering various tools to presented problems that concerned the na- sionals. This is based on self-evaluation to success” for this approach.

April May June July that they can provide high quality, accessible teams in the field who have been experimen- tional level (complexity of the supply network, and regular follow-up of the trainers, March January and sustainable treatment to people living ting with them and adapting them to their shortages) to National HIV Program managers. with the help of a framework to eva- February 3. The assessement tools were shown with HIV/AIDS. Based on the principle of non- specific context. A road map listing the commitment of the luate the acquisition and implementa- to be effective (assessement sheet, Follow up of active patient files receiving ARV substitution, Solthis supports local capacity different actors was drafted during this mee- tion of the operational goals that were exercises in participative analysis) but building through training, material support, The experience in Guinea ting, and was contractualized in a three party worked on during training sessions. the most difficult phase is clearly fol- organization of patient treatment programs partnership protocol. A table of indicators for low-up of the process. This is where and help drafting national HIV policies. Solthis has been working in Guinea since 2008 follow-up and improving performance, crea- Phase 3: Follow-up/Study the emphasis must now be placed: Number of new patients Because the technical assistance offered by on national level and in the centers in the re- ted from routine data collected by the centers, Indicators of activities and results, most with TB on strengthening follow-up and ap- Solthis coincided with the arrival of antire- gions of Conakry and Boké. In 2012 Solthis was an integral part of the protocol. of which had already been obtained propriation of the new process by the troviral tritherapies in Africa, the initial goals began a process of restructuring its support in during routine data collection, were Number of patients with healthcare teams (with specific work for capacity building were obvious: training the centers with the healthcare teams and the Phase 2: Implementation used to evaluate progress in the per- TB, and tested for HIV with a “focal point” who is responsible healthcare personnel to provide pluridisci- intermediary authorities based on quality im- Besides their routine activities, the healthcare formance of each treatment center. for follow-up of the approach in each plinary management of HIV/AIDS to patients The novelty of this approach to quality Number of patients with center), on varying the methods of re- provement. This included 9 healthcare centers teams added “new” activities to the road map TB, and tested as HIV + in treatment facilities. However the constant (4 in Conakry and 5 in the Boké region). to achieve the solutions they had identified. improvement is the development of tro-information to the teams and their growth in the number of patients creates or- For example it was decided that pharmacists graphic tools to facilitate visualization Number of patients performance, on improving post-trai- ganizational problems, which is an obstacle to Phase 1 Analysing would present a report on supplies during and analysis by healthcare teams and coinfected and receiving ning follow-up methods, and on moni- high quality patient management. After having determined needs during regular each team meeting to improve communi- authorities, so that the data could be HAART toring the participation of authorities The challenge today is not only to continue visits in the field, Solthis organized meetings cation between prescribing physicians and used as a decisional aid (see graphics). 1st semester 2012 2nd semester 2012 in charge of supervising the centers. capacity building for healthcare personnel, for a participative diagnosis in each treatment pharmacists. Regional authorities confirmed but also to provide support for other complex center with all of the actors involved in the their intention to include HIV in their moni- Phase 4: Evaluation/Action In 2013 we should be able to measure issues of patient management in order to li- management of HIV/AIDS. toring activities and to take an active role in Between now and the end of 2012, the Follow-up of management of HIV/TB the impact of this approach on the mit the number of lost to follow-up patients, Each of the actors presented their depart- reporting back HIV data. Some of them sug- collected data will be analyzed on a management of HIV in the participa- or prevent mis-quantification of needs. Based ment’s activities and the difficulties encounte- gested that retroinformation on 6 month center by center basis then presented ting centers. However, a very positive on the realities in the field, Solthis teams are red which were generally associated with the monitoring results be provided to the teams during intercenter meetings, with na- response has already been observed, dedicated to improving the organization of following aspects: during that on site team meetings. The ac- tional authorities, so that experiences thanks to improved communication in task shifting of specialized human resources, l organizational: lack of communication on tivities proposed by Solthis fall in the areas can be exchanged and good practices Number of women who the healthcare teams, their reflections reorganizing the patient treatment program, patient follow-up, availability of supplies, of expertise, organization and material. To can be strengthened. A second cycle came during the month on their activities, and the participation consultation times, the use of consultation of quality improvement will be begun, of treatment center directors and local l material: out of date locales, lack of space improve management of HIV-Tuberculosis rooms and improving archiving of files and Number of women who making confidentiality during counseling co-infection, for example, training programs with mutually agreed targets for each authorities. These three factors help data collection... came and tested for HIV difficult ; were organized: laboratory technicians were center. This will mean choosing and give meaning to daily practices and are At the same time the substantive work per- trained on diagnostic testing good practices, analyzing specific quality indicators an important source of motivation for l skills: availability and skill of human re- Number of women who formed by Solthis to improve pedagogical healthcare professionals were made aware with the healthcare teams: do dia- healthcare professionals. n sources in the healthcare facilities. came and tested as HIV + methods has shown the crucial importance of the importance of testing in patients with gnostic testing practices respect qua- of post-training follow-up and of continuous The directors of the different facilities presen- tuberculosis and prescribing physicians were lity standards? Do patients begin ARV support in between training sessions if real ted ideas for improvement to the regional and informed of the national guidelines on the treatment according to national pro- May May June April

change is to be made in healthcare practices. tocols? Do they remain in the patient March January It has also shown that it is increasingly im- treatment programs? February l Tools : portant to improve measurement of change Needs assessment by the l Evaluation of the rate of pluridisciplinary Solthis Follow up and testing of HIV in Postnatal consultation l Capacity building manual in professional practices and in the quality of success of road map team (assessment, analysis of What is the conclusion after one l Grid for the different thematic re- management in the centers receiving support l Analysis of the impact of strong/weak points) experimental year? the changes on quality l Participative diagnosis in views from Solthis. improvement the centers with the patient l Guide to participative diagnosis and l “Adopt, adapt, or abandon” management teams 1. The healthcare teams and the autho- the actions tested for PHASE 4 PHASE 1 l Feedback workshop with guides to leading various sequences To improve its support of change, Solthis has improvement regional and national rities were enthusiastic about the parti- Evaluate Analyze of the analysis decided to adopt a structured approach in the l Identification of priority authorities cipative approach, but care must be ta- Number of patients treatment centers and has proposed a metho- actions for the next phase Act Plan l Three party contract ken not to spend all the time discussing l Road map (partnership protocols, with appointment and l  dology to its field teams which is based on roadmaps) the difficulties encountered. So that who did not come Partnership protocols two major theories: the participants do not lose interest, Number of patients l Post-training evaluation grid and with appointment and l the challenge is to focus discussions self evaluation – Training modules Change Management theory, which is not who come specific to health but which focuses upon on possible improvements. In this way on clinical mentoring. l Follow the road map PHASE 3 PHASE 2 the appropriation of the goals of change by l Organizational support training sessions can be a time for par- l Analysis of the progress of Study Implement participants, follow up indicators (team meetings) ticipants to project themselves positi- follow l Material support vely into change, based on standards of l Methods to improve the quality of care de- (prescription kits, laboratory material, rehabilitation) good practices, which generally renews veloped for hospital management in the June July August September l Capacity building (training, motivation. developed countries and adapted by Anglo post-training follow-up) Saxon NGOs for the management of HIV/ Attendance at pharmacy appointments

14 Solthis Newsletter • n°14 • December 2012 Solthis Newsletter • n°14 • December 2012 15 Sophie Calmettes Director of Operations Global Health Caroline Gallais Grant development officer

agreement. Once again the goal is countries to satisfy The Global Fund: at the heart of the reform to accelerate and simplify the pro- specific conditions, The Board of the Global Fund will meet on November 14 and 15 to validate major changes in the functioning cess, but there is some fear that problems with local this new model turns into a very LFA or ongoing inves- of the Global Fund. Update on the main issues at stake. complicated process, as suggested tigations by the Office by the figure below. of the Inspector Gene- For a year now the Global Fund to fight AIDS, quality assurance, Local Fund Agents (LFA), ral (OIG). As a result the tuberculosis and malaria has been in a state Country Coordination Mechanisms (CCM), or The new funding model Rather than creating a consensus, grants in Mali, Niger of major upheaval. Confronted by both the grant renewals. these decisions are the subject of and Guinea have been world financial crisis and the crisis of confi- The last Global Fund Board meeting, which intense debate among the diffe- blocked since the OIG 2 dence because of revelations of fraud in cer- Moreover “Country teams” have been crea- was held on September 13 and 14 in Geneva, rent delegations. For example, the investigation while the tain recipient countries, the Global Fund has ted in each of the geographic departments. began defining the basic tenets of the new Secretariat and most of the inter- reports of these inves- begun a process of profound reform in view Each team includes: funding model by confirming two principles national funding agencies support tigations have still not of its new Strategy 2012 – 2016. This reform l a portfolio manager, whose decisional about the distribution of grants among the the idea of a cap for each country been published (this is built around two main axes: reorganization power has been increased, assisted by one countries and the process of filing proposals that would be transmitted to the has been going on for of the Executive Secretariat and changing the or several program managers, by the countries. These decisions are based, countries before they submit their two years in Mali). funding model of the Global Fund. l technical assistants who work on questions in particular, on the work of the Strategy, In- funding requests. On the other To deal with these si- of supplies, follow-up/evaluation and finan- vestment and Impact Committee (SIIC), which hand, NGO delegations and the tuations, the division Reorganization of the Secretariat cial and administrative management. is one of 3 committees created by the Board Communities support the idea of grant management The main change is that these assistants are to reform the system of governance (Finan- of a distribution of funds among Figure 2. New model of financing for the Global Fund: has placed these A larger «Grant Management» division now an integral part of grant management. cial and Operational Results Committee and countries from the same group, schema for resource allocation grants on a watch list The basic principle of the Global Fund reform Although in theory strengthening grant ma- the Audit and Ethics Committee) where the from a maximum predefined bud- and a specific action is to refocus the organization on grant mana- nagement should make it possible to manage French delegation is a member. get, after they have simultaneous plan has been drafted gement to improve the efficacy and reactivity grants more effectively, especially by sim- sent their grant requests so that countries can allocated. Once again negotiations are tense for each of them. If this initiative seems to of the Secretariat in this area. This will to im- plifying communication among Global Fund First certainty: available funds will be design proposals inclusive of all their needs. on how these funds should be spent: while head in the right direction, we are still waiting prove grant management grew from the com- staff members, the effects have yet to be ma- allocated to bands of countries The Board meeting in September finally de- the Global Fund would like to privilege fun- for the results to materialize on the field while plete reorganization of the Secretariat1 which terialized in the field. For example, there are Most available funds will not be granted any- cided in favor of a compromise between the ding of specific “high impact” interventions the persistence of the bottlenecks lead to benefited grant management and whose staff still important delays at the Secretariat level more on a case-by-case basis. Instead, pre- two positions, with the creation of two types (for example passing to option B+ for PMTCT) major structural damages for the program of has now grown by 39% by shifting internal re- in revising contract agreements, approving defined budgets will be granted to bands of of funding: numerous actors in the field, including Solthis, involved countries (testing interruption, let- sources. In this new division, the geographical reports and transferring payments. countries in order to privilege funding the l a source of regular but capped funding, defend the use of these funds to top up exis- ting staff go…) and put into questions the regions have been redefined with 5 depart- countries with the greatest disease burden l a separate source of funding to reward the ting grants- which in many countries do not progress they have made towards universal ments: A new Executive Director and the fewest resources. The remaining countries with the best results or the best in- cover all existing needs, even to purchase me- access. This situation emphasizes how urgent l 3 regions with «high impact» countries which Whether this reform becomes truly operatio- funds could be granted on a case-by-case ba- terventions (“incentive funding”). dical products. it is to achieve organizational reform of the include the 20 countries representing 70% of nal also depend upon the next Global Fund sis to reward the best proposals or to fund the Numerous details must still be clarified before Global Fund, but also show the remaining the global burden disease (Nigeria, Demo- Director. The mandate of the present Gene- implementation of specific strategies. Thus, this new funding model will be finally adopted Remaining questions grey areas, especially in relation to crucial cratic Republic of Congo, South Africa, etc.) ral Director, Gabriel Jaramillo3 finishes at the this reform confirms that funding for groups at the next Board meeting in November 2012, Essential decisions will be made on the new unanswered questions such as the preroga- l 2 regions with the remaining countries end of the year, and the process of finding a of countries will be capped. How these caps to begin implementation in 2013. Many NGO funding model during the next Board mee- tives and the status of the OIG, the role of the The countries where Solthis work – Guinea, successor has begun. The Board has created will be defined (by country or by group) and are afraid that the next Board meeting recant ting on November 13 and 14 in Geneva. In LFA and more generally, the policy of the Glo- Sierra Leone, Mali and Niger – are part of the a committee to draw up a short list (gender when the recipient countries will be informed on the second source of uncapped funding. the meantime certain grants remain purely bal Fund in relation to risk management. “Africa” department, which is directed by Lelio equal) of a maximum of 4 candidates, and (before or after grant proposals have been and simply stuck in the field. According to the n Marmora. interviews are being held to determine this received) still remain to be defined. Although While waiting for the new funding model: 1.6 Secretariat, these “stuck grants” represent 10% A sixth department “Grant Management list. The future Global Fund Director will be the goal of these caps is to simplify the pro- billion dollars of “early funding” are available of active grants (51/519). There are programs Support” is in charge of supporting other de- elected by the Board from this list at the next cess of managing available funds, much While waiting for the new funding model that have still not received payment three partments on questions of risk management, Board meeting. criticism has been heard from civil society to become official, the Global Fund has 1.6 months after signature of the grant agree- 1. The Global Fund Secretariat manages the grant portfolio, because this approach goes against the foun- billion dollars available to be distributed. ment, or have not received payments for at including screening proposals submitted, issuing instructions ding principles of the Global Fund, which was While approximately 600 million dollars will least 6 months for ongoing grants. A total of to disburse money to grant recipients and implementing performance-based funding of grants. More generally, the based on funding according to the needs ex- be used for the Transitory Funding Mecha- 681 million dollars is waiting to be distributed. Secretariat is tasked with executing Board policies; resource pressed by each country, and this could result nism, which partially replaced Round 11 The Global fund has analyzed the different mobilization; providing strategic, policy, financial, legal and administrative support; and overseeing monitoring and in underestimated grants [4]. In addition limi- (which was cancelled for lack of funds), there factors that account for this situation: slow evaluation. It is based in Geneva and has no staff located outside ting demands may prevent progress to uni- is still 1 billion dollars of “early funding” to be negotiations with the countries, failure of the its headquarters. 2. On the same subject see Newsletter # 10. Interview with Joanne versal access, which necessitates to increase Carter the overall volume of funding. 3. Also see Newsletter # 13. Interview with Gabriel Jaramillo 4. See the interassociative press release « Monsieur Jaramillo : les plafonds vont écraser le Fonds mondial ! » Second certainty: the end of rounds of NSP Unfunded quality funding support When a robust National demand Strategy or Investment Board The process of rounds of funding is defini- Case are available TRP approval NSP: invest- review (final budget) tively over. Instead, the Global Fund would ment case Determine / Country Concept Note Grant-making like to use a more flexible model, which will (prioritized / approve adjusted (different grants) dialogue budget) funding amount allow countries to file proposals for conti- Band allocation Potential nuous funding. Instead of a complete propo- TRP Incentive funding sal which needs to be drafted by the CCM, the Indicative funding review Allocation range countries must now submit a shorter concept formula note based on the country’s national strategy, which will then serve as a basis for a conti- Total allocation for potential funding amount nuing dialogue with the Technical Review Pa- nel (TRP) and the Secretariat until a complete Figure 1. Global Fund 2012 proposal development and, in the end, a grant Figure 3. Process of funding grants – Global Fund 2012

16 Solthis Newsletter • n°14 • December 2012 Solthis Newsletter • n°14 • December 2012 17 Dominique Pobel Equilibres & Populations Solthis News Elodie Besnier Solthis ––– New projects, new partners ––– Girls, teenage girls, woman: obtaining the right to health for ALL ! INTERVIDA – Initiative 5 % - MADAGASCAR - MALI: Health Virology workshop in Antananarivo Besides the biological and physiological dif- adolescents between 15 - 19 years old and any actions which goal is to reinforce the au- Education Its partners in Madagascar have asked Solthis to pro- ferences between men and women, there are 2 million under the age of 15 1,3,5. tonomy of women and girls, help improving vide technical assistance to Canal 1 of Initiative 5% to culturally-based differences due to gender re- l Maternity and birth control: many women durably mother-infant heath programs and « Support the CNLS in optimizing therapeutic management and capacity building for supply lationships , which change depending on the must face increased medical risks due to the status of women and girls. Limiting wo- The NGO INTERVIDA provided 36.000€ of co- procurement and management of HIV stock». Dr Franck Lamontagne (Medical Coordinator) and period and the context. In all regions of the births occurring too close together be- men’s health to maternal and infant health funding for the project « Education for Health Etienne Guillard (Pharmacy Manager) of Solthis completed a first mission from October 16 – 29. world, these differences are marked by power cause they cannot decide whether to use maintains the unequal status of women and » which was begun in the Ségou région by Besides evaluating needs, three days of workshops were organized on the virological specificities hierarchy in favor of men and by inequalities birth control (even if they supposedly have limits the results of health programs. Solthis (La Lettre de Solthis n°13). The goal of of HIV in Madagascar, in association with the CNLS and the Minister of Health. Dr Marie-Laure against women. the right to). In western Africa only 9% of this project is to improve access to diagnostic Chaix (Necker Hospital, Paris) and Dr Jean-Paul Viard (Hôtel-Dieu Hospital, Paris) experts from the couples use some type of modern birth Turning rights into reality testing and treatment in the Ségou region. Solthis Scientific Committee also participated in these workshops. Inequalities in power and in the control of re- control (pill, injection, implant, condoms) Legal frameworks, national programs (law on This is based on activities to raise awareness On the first day, the results of a collaborative study between CHU Necker, Solthis and the LNR sources affect women’s access to social and and 20 - 30% of women face unmet-needs sexual health and reproduction, strategy for in high-risk groups (men having sex with men, on the virological profile of people infected with HIV were presented and their influence on pre- health services physically (access to transport, for family planning1,5. reproductive health in children and adoles- sex workers, seasonal workers, military men vention and the national therapeutic strategy were discussed. The next two days were dedicated freedom of movement), financially (payment l STD and the feminization of AIDS: in Africa cents, strategy to promote women’s rights) etc), opinion leaders (religions, political and to specifically managing therapeutic failure in the Malian epidemic with individual reporting of for care) and socio-culturally (discrimination 75% of new HIV/AIDS infections in the 15- as well as international or regional texts (Ma- journalists) and teachers. results to doctors. of young girls in healthcare and counseling 24 year old age group involve girls. Even puto Protocol, Convention for the elimination Present in Mali since 2002, INTERVDIA is a de- Approximately 50 Malian institutional healthcare managers and doctors participated in the three centers, difficult access to information, inabi- when they know how to prevent STD, and of all forms of discrimination against women, velopmental NGO which supports vulnerable days of workshops. lity to decide to consult), especially in deve- can obtain these means, girls and women International Convention on children’s rights) populations, mainly women and children to loping countries (DC). The risk factors asso- cannot negotiate using them during sexual which are in effect in most countries, provide promote access to education and high qua- NIGER, GUINEA – Project for capacity building in healthcare systems ciated with gender inequalities exist at every relations1,5. a framework and a foundation to be used to lity care. The project by Solthis and its Guinean and Nigerian partners was preselected by the steering stage of life (Figure). Gender inequalities and lobby or take action in the field so that, exis- committee for Canal 2 of Initiative 5% coordinated by France Expertise Internationale (FEI) in violence are especially visible in the areas of Fighting the causes of the problem ting women’s and girl’s rights can be effecti- UNITAID – GUINEA - Open response to the call for projects on the theme «Capacity building in healthcare systems». The goal of this project is «capacity building for the local implementation and follow-up of medical sexual and reproductive health, with signifi- Under these conditions the fight for women’s vely applied. Polyvalent Platforms (OPP-ERA) cant consequences on maternal and infant health must not be limited to programs that management of HIV/AIDS in Niger and Guinea. The project, which will last three years, should be The OPP-ERA project sponsored by the health which are not sufficiently taken into reduce maternal and infant morta/morbidity Although in the past few decades this topic signed in the upcoming months and should be launched at the beginning of 2013 consortium of French partners: FEI, GIP account. and that are only active for obstetrical and has become more visible, changes in the field ESTHER, ANRS, Sidaction and Solthis was ap- neonatal care, or that only target women on are slower to come. We must continue to de- proved by UNITAID. The goal of this project Alarming figures the demand side. Activities and services that fend the cause of women’s and girl’s rights at is to improve access to HIV viral load testing ––– In countries ––– Low recognition of the status of women and respond to the specific needs of teenagers the International Conference on Population and to the early diagnosis of HIV infection in GUINEA: Towards a project for the NIGER : Decentralization of patient girls, gender and power inequalities, and pre- (who are barely affected by existing programs, and Development (ICPD + 20) and above all, newborns by opening the market of viral load support of patient therapeutic management to district hospitals: judicial socio-cultural norms are a dangerous and who are underrepresented in the health- in the post MDG’s agenda. n measurement technologies to competition mixture for women’s and girls’ health in DC. care centers), actions targeting men and com- education initial training sessions in Maradi from new suppliers. A pool of laboratories will l Sexual abuse and violence: often goes unpu- munity leaders on the topics of family plan- For the moment the public healthcare centers The United Nations and the ULSS gave the be equipped with Open Polyvalent Platforms nished. This concerns more than 30% of the ning, the rights of teenagers and women, and in Guinea have developed very few activities, Solthis team in Niger a capacity building mis- – OPP in the 4 countries targeted for the pro- girls under the age of 18 and it occurs 2 to 3 on sexuality in general are essential if social 1. Women and health: today’s realities, tomorrow’s programs, WHO, thus everything must be created. sion in the Maradi region. This was a pilot pro- 2009. http://www.who.int/gender/women_health_report/fr/ ject (Burundi, Cameroon, Ivory Coast and Gui- times more often in girls than in boys1,2. norms are to change and if there is to be more Last September 26 and 27 a workshop to dis- ject for decentralization of HIV management index.html nea). Solthis is managing project implementa- l Early marriages and pregnancies: in western equality between men and women on deci- 2. Biddlecom AE et al., Protéger la prochaine génération en Afrique cuss this question was organized at the CHU to district healthcare facilities based on the subsaharienne : apprendre des adolescentes pour prévenir le tion in Guinea. The beginning of the project is and central Africa, even when the legal age sions about sexuality and reproduction. More Donka and the following departments partici- principle of integrating HIV activities into exis- VIH-Sida et les grossesses non désirées, Guttmacher Institute, planned for 2013. of marriage is 18 years old, 45% of the girls generally, taking a gender-focused approach, 2008 pated: Dermatology, Infectious diseases, Inter- ting departments. Solthis leads, coordinates 3. Facts and figures on women’s health WHO, 2011http://www.who. nal medicine as well as Hospital Management and provides training as well as material and of that age are already married, compared to that takes into account the relationship of int/features/factfiles/women/fr/index.html fewer than 5% of the boys5. Worldwide, early power between men and women, in any 4. Violence against women : violence of an intimate partner and and the Patient Association, Fondation Espoir organizational support to the participating sexual violence, Aide mémoire n° 239, WHO, 2011 http://www. Guinea. This workshop was led by Solthis, in structures. In September, the first joint United pregnancy - which is the primary cause of health programs, and in any activities promo- who.int/mediacentre/factsheets/fs239/fr/index.html mortality in adolescents - involves 14 million ting women’s and girl’s rights will, along with 5. Statistics WHO, World Bank, UNICEF, UNFPA particular Etienne Guillard, who is manager of Nations-Solthis-ULSS mission began in the re- ––– Agenda 2013 ––– PTE at Solthis. gions. Approximately 123 people were trained Discussions were organized on the problems by Solthis in HIV (intial training or re-training) CROI, 20th Conference on Retroviruses and inherent in patient support and TPE which have PMTCT, dispensing treatment and TPE. Opportunistic Infections – 3-6 March in been identified in the other countries where Atlanta (United States) Solthis has activities or by other actors: the SIERRA LEONE: Support of goals, the contents, how and who to include in AFRAVIH, Workshop on clinical research the patient treatment program, how to orga- supply procurement and stock methodology - 25-28 March in Grand Bassam nize healthcare facilities and funding (Lettre de management (Ivory Cost) Solthis n°13)… Despite the many challenges, In association with the Minister of Health and Institut Pasteur, 30 years of HIV science – 21- basic goals were established during the works- the National HIV/AIDS Secretariat, Solthis orga- 23 May in Paris (France) hop: sharing a common vision of this support, nized a national workshop from October 22-23 identifying the actors who can manage this in Freetown for HIV counselors (in charge of IAS, 7th Conference on HIV Pathogenesis, activity to provide them with capacity building, management of HIV patients) and pharmacists. 0-9 years 10-18 years 19-59 years More than 60 years-old Treatment and Prevention - 30 June - 3 July in identifying the questions that these actors must Debates were held on how to include the ma- Selection of fetuses / new Early pregnancies and Unwanted pregnancies, Over morta/morbidity Kuala Lumpur (Malaysia) respond to and the errors to be avoided to en- nagement of HIV products in the national phar- born on the basis of sex morta/morbidity maternity numerous and closed linked with sure long term functioning of these activities. maceutical supply system as these are at pre- Female sexual Mutilation Sexual violence Morta/morbidity maternity non transmissible Sexual Violences and rapes HIV/AIDS ans STD Gender violence deseases Solthis : 10 years Solthis will continue to support the structuring sent managed by two different systems. «The Discrimination HIV/AIDS and STDs 19-20 september in Paris (France) of this patient support program in this pilot active participation of those at the workshop is on healthcare access Mental Health project at the Donka Hospital. Feedback from a sign that this will be a promising collaboration ICASA, 17th International Conference on AIDS these experiences will certainly then be applied » declared Sophie Ouvrard, referent Pharmacist Risk factors for the health of the women at every stage of the cycle of life in developing and STIs in Africa - 7-11 December Durban to other structures so that a maximum number and leader of this workshop. This project should countries (South Africa) of Guineans can profit from these efforts. be launched at the beginning of 2013.

18 Solthis Newsletter • n°14 • December 2012 Solthis Newsletter • n°14 • December 2012 19 Your next appointment with Solthis : Save the date !

Scientific Conference 10 years of Solthis

19-20 september 2013 © Andres Koryzma© Andres

On the occasion of the tenth birthday, Solthis will organize a symposium international in presence of all the teams of the ground on topic « 10 years of ARV in Africa: what bilans? what perspectives? » We wait for you !

Solthis Team

Chair: Pr Christine Katlama Field Teams Scientific working Group

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